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Regulation (EU) 2017/745 of the European Parliament and of the CouncilShow full title

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)

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  1. Introductory Text

  2. CHAPTER I SCOPE AND DEFINITIONS

    1. Article 1.Subject matter and scope

    2. Article 2.Definitions

    3. Article 3.Amendment of certain definitions

    4. Article 4.Regulatory status of products

  3. CHAPTER II MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT

    1. Article 5.Placing on the market and putting into service

    2. Article 6.Distance sales

    3. Article 7.Claims

    4. Article 8.Use of harmonised standards

    5. Article 9.Common specifications

    6. Article 10.General obligations of manufacturers

    7. Article 11.Authorised representative

    8. Article 12.Change of authorised representative

    9. Article 13.General obligations of importers

    10. Article 14.General obligations of distributors

    11. Article 15.Person responsible for regulatory compliance

    12. Article 16.Cases in which obligations of manufacturers apply to importers, distributors or other persons

    13. Article 17.Single-use devices and their reprocessing

    14. Article 18.Implant card and information to be supplied to the patient with an implanted device

    15. Article 19.EU declaration of conformity

    16. Article 20.CE marking of conformity

    17. Article 21.Devices for special purposes

    18. Article 22.Systems and procedure packs

    19. Article 23.Parts and components

    20. Article 24.Free movement

  4. CHAPTER III IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES

    1. Article 25.Identification within the supply chain

    2. Article 26.Medical devices nomenclature

    3. Article 27.Unique Device Identification system

    4. Article 28.UDI database

    5. Article 29.Registration of devices

    6. Article 30.Electronic system for registration of economic operators

    7. Article 31.Registration of manufacturers, authorised representatives and importers

    8. Article 32.Summary of safety and clinical performance

    9. Article 33.European database on medical devices

    10. Article 34.Functionality of Eudamed

  5. CHAPTER IV NOTIFIED BODIES

    1. Article 35.Authorities responsible for notified bodies

    2. Article 36.Requirements relating to notified bodies

    3. Article 37.Subsidiaries and subcontracting

    4. Article 38.Application by conformity assessment bodies for designation

    5. Article 39.Assessment of the application

    6. Article 40.Nomination of experts for joint assessment of applications for notification

    7. Article 41.Language requirements

    8. Article 42.Designation and notification procedure

    9. Article 43.Identification number and list of notified bodies

    10. Article 44.Monitoring and re-assessment of notified bodies

    11. Article 45.Review of notified body assessment of technical documentation and clinical evaluation documentation

    12. Article 46.Changes to designations and notifications

    13. Article 47.Challenge to the competence of notified bodies

    14. Article 48.Peer review and exchange of experience between authorities responsible for notified bodies

    15. Article 49.Coordination of notified bodies

    16. Article 50.List of standard fees

  6. CHAPTER V CLASSIFICATION AND CONFORMITY ASSESSMENT

    1. SECTION 1 Classification

      1. Article 51.Classification of devices

    2. SECTION 2 Conformity assessment

      1. Article 52.Conformity assessment procedures

      2. Article 53.Involvement of notified bodies in conformity assessment procedures

      3. Article 54.Clinical evaluation consultation procedure for certain class III and class IIb devices

      4. Article 55.Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices

      5. Article 56.Certificates of conformity

      6. Article 57.Electronic system on notified bodies and on certificates of conformity

      7. Article 58.Voluntary change of notified body

      8. Article 59.Derogation from the conformity assessment procedures

      9. Article 60.Certificate of free sale

  7. CHAPTER VI CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS

    1. Article 61.Clinical evaluation

    2. Article 62.General requirements regarding clinical investigations conducted to demonstrate conformity of devices

    3. Article 63.Informed consent

    4. Article 64.Clinical investigations on incapacitated subjects

    5. Article 65.Clinical investigations on minors

    6. Article 66.Clinical investigations on pregnant or breastfeeding women

    7. Article 67.Additional national measures

    8. Article 68.Clinical investigations in emergency situations

    9. Article 69.Damage compensation

    10. Article 70.Application for clinical investigations

    11. Article 71.Assessment by Member States

    12. Article 72.Conduct of a clinical investigation

    13. Article 73.Electronic system on clinical investigations

    14. Article 74.Clinical investigations regarding devices bearing the CE marking

    15. Article 75.Substantial modifications to clinical investigations

    16. Article 76.Corrective measures to be taken by Member States and information exchange between Member States

    17. Article 77.Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination

    18. Article 78.Coordinated assessment procedure for clinical investigations

    19. Article 79.Review of coordinated assessment procedure

    20. Article 80.Recording and reporting of adverse events that occur during clinical investigations

    21. Article 81.Implementing acts

    22. Article 82.Requirements regarding other clinical investigations

  8. CHAPTER VII POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE

    1. SECTION 1 Post-market surveillance

      1. Article 83.Post-market surveillance system of the manufacturer

      2. Article 84.Post-market surveillance plan

      3. Article 85.Post-market surveillance report

      4. Article 86.Periodic safety update report

    2. SECTION 2 Vigilance

      1. Article 87.Reporting of serious incidents and field safety corrective actions

      2. Article 88.Trend reporting

      3. Article 89.Analysis of serious incidents and field safety corrective actions

      4. Article 90.Analysis of vigilance data

      5. Article 91.Implementing acts

      6. Article 92.Electronic system on vigilance and on post-market surveillance

    3. SECTION 3 Market surveillance

      1. Article 93.Market surveillance activities

      2. Article 94.Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance

      3. Article 95.Procedure for dealing with devices presenting an unacceptable risk to health and safety

      4. Article 96.Procedure for evaluating national measures at Union level

      5. Article 97.Other non-compliance

      6. Article 98.Preventive health protection measures

      7. Article 99.Good administrative practice

      8. Article 100.Electronic system on market surveillance

  9. CHAPTER VIII COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS

    1. Article 101.Competent authorities

    2. Article 102.Cooperation

    3. Article 103.Medical Device Coordination Group

    4. Article 104.Support by the Commission

    5. Article 105.Tasks of the MDCG

    6. Article 106.Provision of scientific, technical and clinical opinions and advice

    7. Article 107.Conflict of interests

    8. Article 108.Device registers and databanks

  10. CHAPTER IX CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES

    1. Article 109.Confidentiality

    2. Article 110.Data protection

    3. Article 111.Levying of fees

    4. Article 112.Funding of activities related to designation and monitoring of notified bodies

    5. Article 113.Penalties

  11. CHAPTER X FINAL PROVISIONS

    1. Article 114.Committee procedure

    2. Article 115.Exercise of the delegation

    3. Article 116.Separate delegated acts for different delegated powers

    4. Article 117.Amendment to Directive 2001/83/EC

    5. Article 118.Amendment to Regulation (EC) No 178/2002

    6. Article 119.Amendment to Regulation (EC) No 1223/2009

    7. Article 120.Transitional provisions

    8. Article 121.Evaluation

    9. Article 122.Repeal

    10. Article 123.Entry into force and date of application

  12. Signature

  13. ANNEXES

    1. ANNEX I

      GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

      1. CHAPTER I GENERAL REQUIREMENTS

        1. 1. Devices shall achieve the performance intended by their manufacturer and...

        2. 2. The requirement in this Annex to reduce risks as far as...

        3. 3. Manufacturers shall establish, implement, document and maintain a risk management...

        4. 4. Risk control measures adopted by manufacturers for the design and...

        5. 5. In eliminating or reducing risks related to use error, the...

        6. 6. The characteristics and performance of a device shall not be...

        7. 7. Devices shall be designed, manufactured and packaged in such a...

        8. 8. All known and foreseeable risks, and any undesirable side-effects, shall...

        9. 9. For the devices referred to in Annex XVI, the general safety...

      2. CHAPTER II REQUIREMENTS REGARDING DESIGN AND MANUFACTURE

        1. 10. Chemical, physical and biological properties

          1. 10.1. Devices shall be designed and manufactured in such a way...

          2. 10.2. Devices shall be designed, manufactured and packaged in such a...

          3. 10.3. Devices shall be designed and manufactured in such a way...

          4. 10.4. Substances

            1. 10.4.1. Design and manufacture of devices

            2. 10.4.2. Justification regarding the presence of CMR and/or endocrine-disrupting substances

            3. 10.4.3. Guidelines on phthalates

            4. 10.4.4. Guidelines on other CMR and endocrine-disrupting substances

            5. 10.4.5. Labelling

          5. 10.5. Devices shall be designed and manufactured in such a way...

          6. 10.6. Devices shall be designed and manufactured in such a way...

        2. 11. Infection and microbial contamination

          1. 11.1. Devices and their manufacturing processes shall be designed in such...

          2. 11.2. Where necessary devices shall be designed to facilitate their safe...

          3. 11.3. Devices labelled as having a specific microbial state shall be...

          4. 11.4. Devices delivered in a sterile state shall be designed, manufactured...

          5. 11.5. Devices labelled as sterile shall be processed, manufactured, packaged and,...

          6. 11.6. Devices intended to be sterilised shall be manufactured and packaged...

          7. 11.7. Packaging systems for non-sterile devices shall maintain the integrity and...

          8. 11.8. The labelling of the device shall distinguish between identical or...

        3. 12. Devices incorporating a substance considered to be a medicinal product...

          1. 12.1. In the case of devices referred to in the first...

          2. 12.2. Devices that are composed of substances or of combinations of...

        4. 13. Devices incorporating materials of biological origin

          1. 13.1. For devices manufactured utilising derivatives of tissues or cells of...

          2. 13.2. For devices manufactured utilising tissues or cells of animal origin,...

          3. 13.3. For devices manufactured utilising non-viable biological substances other than those...

        5. 14. Construction of devices and interaction with their environment

          1. 14.1. If the device is intended for use in combination with...

          2. 14.2. Devices shall be designed and manufactured in such a way...

          3. 14.3. Devices shall be designed and manufactured in such a way...

          4. 14.4. Devices shall be designed and manufactured in such a way...

          5. 14.5. Devices that are intended to be operated together with other...

          6. 14.6 Any measurement, monitoring or display scale shall be designed and...

          7. 14.7. Devices shall be designed and manufactured in such a way...

        6. 15. Devices with a diagnostic or measuring function

          1. 15.1. Diagnostic devices and devices with a measuring function, shall be...

          2. 15.2. The measurements made by devices with a measuring function shall...

        7. 16. Protection against radiation

          1. 16.1. General

          2. 16.2. Intended radiation

          3. 16.3. Devices shall be designed and manufactured in such a way...

          4. 16.4. Ionising radiation

        8. 17. Electronic programmable systems — devices that incorporate electronic programmable systems...

          1. 17.1. Devices that incorporate electronic programmable systems, including software, or software...

          2. 17.2. For devices that incorporate software or for software that are...

          3. 17.3. Software referred to in this Section that is intended to be...

          4. 17.4. Manufacturers shall set out minimum requirements concerning hardware, IT networks...

        9. 18. Active devices and devices connected to them

          1. 18.1. For non-implantable active devices, in the event of a single...

          2. 18.2. Devices where the safety of the patient depends on an...

          3. 18.3. Devices where the safety of the patient depends on an...

          4. 18.4. Devices intended to monitor one or more clinical parameters of...

          5. 18.5. Devices shall be designed and manufactured in such a way...

          6. 18.6. Devices shall be designed and manufactured in such a way...

          7. 18.7. Devices shall be designed and manufactured in such a way...

          8. 18.8. Devices shall be designed and manufactured in such a way...

        10. 19. Particular requirements for active implantable devices

          1. 19.1. Active implantable devices shall be designed and manufactured in such...

          2. 19.2. Active implantable devices shall be designed and manufactured in such...

          3. 19.3. Active implantable devices and, if appropriate, their component parts shall...

          4. 19.4. Active implantable devices shall bear a code by which they...

        11. 20. Protection against mechanical and thermal risks

          1. 20.1. Devices shall be designed and manufactured in such a way...

          2. 20.2. Devices shall be designed and manufactured in such a way...

          3. 20.3. Devices shall be designed and manufactured in such a way...

          4. 20.4. Terminals and connectors to the electricity, gas or hydraulic and...

          5. 20.5. Errors likely to be made when fitting or refitting certain...

          6. 20.6. Accessible parts of devices (excluding the parts or areas intended...

        12. 21. Protection against the risks posed to the patient or user...

          1. 21.1. Devices for supplying the patient with energy or substances shall...

          2. 21.2. Devices shall be fitted with the means of preventing and/or...

          3. 21.3. The function of the controls and indicators shall be clearly...

        13. 22. Protection against the risks posed by medical devices intended by...

          1. 22.1. Devices for use by lay persons shall be designed and...

          2. 22.2. Devices for use by lay persons shall be designed and...

          3. 22.3. Devices for use by lay persons shall, where appropriate, include...

      3. CHAPTER III REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE

        1. 23. Label and instructions for use

          1. 23.1. General requirements regarding the information supplied by the manufacturer

          2. 23.2. Information on the label

          3. 23.3. Information on the packaging which maintains the sterile condition of...

          4. 23.4. Information in the instructions for use

    2. ANNEX II

      TECHNICAL DOCUMENTATION

      1. The technical documentation and, if applicable, the summary thereof to...

      2. 1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES

        1. 1.1. Device description and specification

        2. 1.2. Reference to previous and similar generations of the device

      3. 2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER

      4. 3. DESIGN AND MANUFACTURING INFORMATION

      5. 4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

      6. 5. BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT

      7. 6. PRODUCT VERIFICATION AND VALIDATION

        1. 6.1. Pre-clinical and clinical data

        2. 6.2. Additional information required in specific cases

    3. ANNEX III

      TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE

      1. The technical documentation on post-market surveillance to be drawn up...

      2. 1. The post-market surveillance plan drawn up in accordance with Article 84....

      3. 2. The PSUR referred to in Article 86 and the post-market surveillance...

    4. ANNEX IV

      EU DECLARATION OF CONFORMITY

      1. The EU declaration of conformity shall contain all of the...

      2. Name, registered trade name or registered trade mark and, if...

    5. ANNEX V

      CE MARKING OF CONFORMITY

      1. 1. The CE marking shall consist of the initials ‘CE’ taking...

      2. 2. If the CE marking is reduced or enlarged, the proportions...

      3. 3. The various components of the CE marking shall have substantially...

    6. ANNEX VI

      INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29, AND THE UDI SYSTEM

      1. PART A INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND...

        1. 1. Information relating to the economic operator

        2. 2. Information relating to the device

      2. PART B CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE...

      3. PART C THE UDI SYSTEM

        1. 1. Definitions

          1. Automatic identification and data capture (‘AIDC’)

          2. Basic UDI-DI

          3. Unit of Use DI

          4. Configurable device

          5. Configuration

          6. UDI-DI

          7. Human Readable Interpretation (‘HRI’)

          8. Packaging levels

          9. UDI-PI

          10. Radio Frequency Identification RFID

          11. Shipping containers

          12. Unique Device Identifier (‘UDI’)

          13. UDI carrier

        2. 2. General requirements

          1. 2.1. The affixing of the UDI is an additional requirement —...

          2. 2.2. The manufacturer shall assign and maintain unique UDIs for its...

          3. 2.3. Only the manufacturer may place the UDI on the device...

          4. 2.4. Only coding standards provided by issuing entities designated by the...

        3. 3. The UDI

          1. 3.1. A UDI shall be assigned to the device itself or...

          2. 3.2. Shipping containers shall be exempted from the requirement in Section 3.1....

          3. 3.3. The UDI shall contain two parts: a UDI-DI and a...

          4. 3.4. The UDI-DI shall be unique at each level of device...

          5. 3.5. If a lot number, serial number, software identification or expiry...

          6. 3.6. Each component that is considered to be a device and...

          7. 3.7. Systems and procedure packs as referred to in Article 22 shall...

          8. 3.8. The manufacturer shall assign the UDI to a device following...

          9. 3.9. A new UDI-DI shall be required whenever there is a...

          10. 3.10. Manufacturers that repackage and/or relabel devices, with their own label...

        4. 4. UDI carrier

          1. 4.1. The UDI carrier (AIDC and HRI representation of the UDI)...

          2. 4.2. In the event of there being significant space constraints on...

          3. 4.3. For single-use devices of classes I and IIa packaged and...

          4. 4.4. For devices exclusively intended for retail point of sale the...

          5. 4.5. When AIDC carriers other than the UDI carrier are part...

          6. 4.6. If linear bar codes are used, the UDI-DI and UDI-PI...

          7. 4.7. If there are significant constraints limiting the use of both...

          8. 4.8. The HRI format shall follow the rules of the UDI...

          9. 4.9. If the manufacturer is using RFID technology, a linear or...

          10. 4.10. Devices that are reusable shall bear a UDI carrier on...

          11. 4.11. The UDI carrier shall be readable during normal use and...

          12. 4.12. If the UDI carrier is readily readable or, in the...

          13. 4.13. In the case of single finished devices made up of...

          14. 4.14. The UDI carrier shall be placed in a manner such...

          15. 4.15. Bar code carriers that include both a UDI-DI and a...

        5. 5. General principles of the UDI database

          1. 5.1. The UDI database shall support the use of all core...

          2. 5.2. Manufacturers shall be responsible for the initial submission and updates...

          3. 5.3. Appropriate methods/procedures for validation of the data provided shall be...

          4. 5.4. Manufacturers shall periodically verify the correctness of all of the...

          5. 5.5. The presence of the device UDI-DI in the UDI database...

          6. 5.6. The database shall allow for the linking of all the...

          7. 5.7. The data for new UDI-DIs shall be available at the...

          8. 5.8. Manufacturers shall update the relevant UDI database record within 30...

          9. 5.9. Internationally-accepted standards for data submission and updates shall, wherever possible,...

          10. 5.10. The user interface of the UDI database shall be available...

          11. 5.11. Data relating to devices that are no longer available on...

        6. 6. Rules for specific device types

          1. 6.1. Implantable devices:

          2. 6.2. Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between uses...

            1. 6.2.1. The UDI of such devices shall be placed on the...

            2. 6.2.2. The UDI-PI characteristics such as the lot or serial number...

          3. 6.3. Systems and procedure packs as referred to in Article 22

            1. 6.3.1. The natural or legal person referred to in Article 22 shall...

            2. 6.3.2. Device contents of system or procedure packs shall bear a...

            3. 6.3.3. Placement of the UDI carrier on systems or procedure packs...

          4. 6.4. Configurable devices:

            1. 6.4.1. A UDI shall be assigned to the configurable device in...

            2. 6.4.2. The configurable device UDI-DI shall be assigned to groups of...

            3. 6.4.3. A configurable device UDI-PI shall be assigned to each individual...

            4. 6.4.4. The carrier of the configurable device UDI shall be placed...

            5. 6.4.5. Each component that is considered a device and is commercially...

          5. 6.5. Device Software

            1. 6.5.1. UDI assignment Criteria

            2. 6.5.2. A new UDI-DI shall be required whenever there is a...

            3. 6.5.3. Minor software revisions shall require a new UDI-PI and not...

            4. 6.5.4. UDI placement criteria for software

    7. ANNEX VII

      REQUIREMENTS TO BE MET BY NOTIFIED BODIES

      1. 1. ORGANISATIONAL AND GENERAL REQUIREMENTS

        1. 1.1. Legal status and organisational structure

          1. 1.1.1. Each notified body shall be established under the national law...

          2. 1.1.2. If the notified body is a legal entity that is...

          3. 1.1.3. If a notified body wholly or partly owns legal entities...

          4. 1.1.4. The organisational structure, allocation of responsibilities, reporting lines and operation...

          5. 1.1.5. The notified body shall clearly document its organisational structure and...

          6. 1.1.6. The notified body shall identify the persons in top-level management...

        2. 1.2. Independence and impartiality

          1. 1.2.1. The notified body shall be a third-party body that is...

          2. 1.2.2. The notified body shall be organised and operated so as...

          3. 1.2.3. The notified body, its top-level management and the personnel responsible...

          4. 1.2.4. Involvement in consultancy services in the field of devices prior...

          5. 1.2.5. The impartiality of notified bodies, of their top-level management and...

          6. 1.2.6. If a notified body is owned by a public entity...

          7. 1.2.7. The notified body shall ensure and document that the activities...

          8. 1.2.8. The notified body shall operate in accordance with a set...

          9. 1.2.9. The requirements laid down in this Section in no way preclude...

        3. 1.3. Confidentiality

          1. 1.3.1. The notified body shall have documented procedures in place ensuring...

          2. 1.3.2. The personnel of a notified body shall observe professional secrecy...

        4. 1.4. Liability

          1. 1.4.1. The notified body shall take out appropriate liability insurance for...

          2. 1.4.2. The scope and overall financial value of the liability insurance...

        5. 1.5. Financial requirements

        6. 1.6. Participation in coordination activities

          1. 1.6.1. The notified body shall participate in, or ensure that its...

          2. 1.6.2. The notified body shall take into consideration guidance and best...

      2. 2. QUALITY MANAGEMENT REQUIREMENTS

        1. 2.1. The notified body shall establish, document, implement, maintain and operate...

        2. 2.2. The quality management system of the notified body shall address...

        3. 2.3. The top-level management of the notified body shall ensure that...

        4. 2.4. The notified body shall require all personnel to formally commit...

      3. 3. RESOURCE REQUIREMENTS

        1. 3.1. General

          1. 3.1.1. Notified bodies shall be capable of carrying out all the...

          2. 3.1.2. The notified body shall ensure that personnel involved in conformity...

          3. 3.1.3. The notified body shall clearly document the extent and limits...

        2. 3.2. Qualification criteria in relation to personnel

          1. 3.2.1. The Notified Body shall establish and document qualification criteria and...

          2. 3.2.2. The qualification criteria referred to in Section 3.2.1 shall refer to...

          3. 3.2.3. The personnel responsible for establishing qualification criteria and for authorising...

          4. 3.2.4. The notified body shall have permanent availability of personnel with...

          5. 3.2.5. The personnel responsible for carrying out product-related reviews (product reviewers),...

          6. 3.2.6. The personnel responsible for carrying out audits of the manufacturer's...

          7. 3.2.7. The personnel with overall responsibility for final reviews and decision-making...

        3. 3.3. Documentation of qualification, training and authorisation of personnel

          1. 3.3.1. The notified body shall have a procedure in place to...

          2. 3.3.2. For all of its personnel referred to in Sections 3.2.3...

        4. 3.4. Subcontractors and external experts

          1. 3.4.1. Notified bodies may, without prejudice to Section 3.2, subcontract certain clearly...

          2. 3.4.2. Where a notified body subcontracts certain conformity assessment activities either...

          3. 3.4.3. Where subcontractors or external experts are used in the context...

        5. 3.5. Monitoring of competences, training and exchange of experience

          1. 3.5.1. The notified body shall establish procedures for the initial evaluation...

          2. 3.5.2. Notified bodies shall review at regular intervals, the competence of...

      4. 4. PROCESS REQUIREMENTS

        1. 4.1. General

        2. 4.2. Notified body quotations and pre-application activities

        3. 4.3. Application review and contract

        4. 4.4. Allocation of resources

        5. 4.5. Conformity assessment activities

          1. 4.5.1. General

          2. 4.5.2. Quality management system auditing

          3. 4.5.3. Product verification

            1. Assessment of the technical documentation

            2. Type-examinations

            3. Verification by examination and testing of every product

          4. 4.5.4. Pre-clinical evaluation assessment

          5. 4.5.5. Clinical evaluation assessment

          6. 4.5.6. Specific Procedures

        6. 4.6. Reporting

        7. 4.7. Final review

        8. 4.8. Decisions and Certifications

        9. 4.9. Changes and modifications

        10. 4.10. Surveillance activities and post-certification monitoring

        11. 4.11. Re-certification

    8. ANNEX VIII

      CLASSIFICATION RULES

      1. CHAPTER I DEFINITIONS SPECIFIC TO CLASSIFICATION RULES

        1. 1. DURATION OF USE

          1. 1.1. ‘Transient’ means normally intended for continuous use for less than...

          2. 1.2. ‘Short term’ means normally intended for continuous use for between...

          3. 1.3. ‘Long term’ means normally intended for continuous use for more...

        2. 2. INVASIVE AND ACTIVE DEVICES

          1. 2.1. ‘Body orifice’ means any natural opening in the body, as...

          2. 2.2. ‘Surgically invasive device’ means:

          3. 2.3. ‘Reusable surgical instrument’ means an instrument intended for surgical use...

          4. 2.4. ‘Active therapeutic device’ means any active device used, whether alone...

          5. 2.5. ‘Active device intended for diagnosis and monitoring’ means any active...

          6. 2.6. ‘Central circulatory system’ means the following blood vessels: arteriae pulmonales,...

          7. 2.7. ‘Central nervous system’ means the brain, meninges and spinal cord....

          8. 2.8. ‘Injured skin or mucous membrane’ means an area of skin...

      2. CHAPTER II IMPLEMENTING RULES

        1. 3.1. Application of the classification rules shall be governed by the...

        2. 3.2. If the device in question is intended to be used...

        3. 3.3. Software, which drives a device or influences the use of...

        4. 3.4. If the device is not intended to be used solely...

        5. 3.5. If several rules, or if, within the same rule, several...

        6. 3.6. In calculating the duration referred to in Section 1, continuous use...

        7. 3.7. A device is considered to allow direct diagnosis when it...

      3. CHAPTER III CLASSIFICATION RULES

        1. 4. NON-INVASIVE DEVICES

          1. 4.1. Rule 1

          2. 4.2. Rule 2

          3. 4.3. Rule 3

          4. 4.4. Rule 4

        2. 5. INVASIVE DEVICES

          1. 5.1. Rule 5

          2. 5.2. Rule 6

          3. 5.3. Rule 7

          4. 5.4. Rule 8

        3. 6. ACTIVE DEVICES

          1. 6.1. Rule 9

          2. 6.2. Rule 10

          3. 6.3. Rule 11

          4. 6.4. Rule 12

          5. 6.5. Rule 13

        4. 7. SPECIAL RULES

          1. 7.1. Rule 14

          2. 7.2. Rule 15

          3. 7.3. Rule 16

          4. 7.4. Rule 17

          5. 7.5. Rule 18

          6. 7.6. Rule 19

          7. 7.7. Rule 20

          8. 7.8. Rule 21

          9. 7.9. Rule 22

    9. ANNEX IX

      CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION

      1. CHAPTER I QUALITY MANAGEMENT SYSTEM

        1. 1. The manufacturer shall establish, document and implement a quality management...

        2. 2. Quality management system assessment

          1. 2.1. The manufacturer shall lodge an application for assessment of its...

          2. 2.2. Implementation of the quality management system shall ensure compliance with...

          3. 2.3. Audit

          4. 2.4. The manufacturer in question shall inform the notified body which...

        3. 3. Surveillance assessment

          1. 3.1. The aim of surveillance is to ensure that the manufacturer...

          2. 3.2. The manufacturer shall give authorisation to the notified body to...

          3. 3.3. Notified bodies shall periodically, at least once every 12 months,...

          4. 3.4. The notified body shall randomly perform at least once every...

          5. 3.5. In the case of class IIa and class IIb devices,...

          6. 3.6. The notified body shall ensure that the composition of the...

          7. 3.7. If the notified body finds a divergence between the sample...

      2. CHAPTER II ASSESSMENT OF THE TECHNICAL DOCUMENTATION

        1. 4. Assessment of the technical documentation applicable to class III devices...

          1. 4.1. In addition to the obligations laid down in Section 2, the...

          2. 4.2. The application shall describe the design, manufacture and performance of...

          3. 4.3. The notified body shall assess the technical documentation using staff...

          4. 4.4. The notified body shall review the clinical evidence presented by...

          5. 4.5. The notified body shall, in circumstances in which the clinical...

          6. 4.6. The notified body shall verify that the clinical evidence and...

          7. 4.7. Based on its assessment of the clinical evidence, the notified...

          8. 4.8. The notified body shall clearly document the outcome of its...

          9. 4.9. The notified body shall provide the manufacturer with a report...

          10. 4.10. Changes to the approved device shall require approval from the...

        2. 5. Specific additional procedures

          1. 5.1. Assessment procedure for certain class III and class IIb devices...

          2. 5.2. Procedure in the case of devices incorporating a medicinal substance...

          3. 5.3. Procedure in the case of devices manufactured utilising, or incorporating,...

            1. 5.3.1. Tissues or cells of human origin or their derivatives

            2. 5.3.2. Tissues or cells of animal origin or their derivatives

          4. 5.4. Procedure in the case of devices that are composed of...

        3. 6. Batch verification in the case of devices incorporating, as an...

      3. CHAPTER III ADMINISTRATIVE PROVISIONS

        1. 7. The manufacturer or, where the manufacturer does not have a...

        2. 8. Each Member State shall require that the documentation referred to in...

    10. ANNEX X

      CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION

      1. 1. EU type-examination is the procedure whereby a notified body ascertains...

      2. 2. Application

      3. 3. Assessment

      4. 4. Certificate

      5. 5. Changes to the type

        1. 5.1. The applicant shall inform the notified body which issued the...

        2. 5.2. Changes to the approved device including limitations of its intended...

        3. 5.3. Changes to the intended purpose and conditions of use of...

      6. 6. Specific additional procedures

      7. 7. Administrative provisions

    11. ANNEX XI

      CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION

      1. 1. The objective of the conformity assessment based on product conformity...

      2. 2. Where an EU type-examination certificate has been issued in accordance...

      3. 3. By way of derogation from Sections 1 and 2 above,...

      4. PART A PRODUCTION QUALITY ASSURANCE

        1. 4. The manufacturer shall ensure that the quality management system approved...

        2. 5. When the manufacturer fulfils the obligations laid down in Section 4,...

        3. 6. Quality management system

          1. 6.1. The manufacturer shall lodge an application for assessment of its...

          2. 6.2. Implementation of the quality management system shall be such as...

          3. 6.3. The first and second paragraph of Section 2.3 of Annex IX shall apply....

          4. 6.4. Section 2.4 of Annex IX shall apply.

        4. 7. Surveillance

        5. 8. Batch verification in the case of devices incorporating, as an...

        6. 9. Administrative provisions

        7. 10. Application to class IIa devices

          1. 10.1. By way of derogation from Section 5, by virtue of the...

          2. 10.2. For class IIa devices the notified body shall assess, as...

          3. 10.3. Where the assessment under Section 10.2. confirms that the class IIa...

          4. 10.4. Samples additional to those taken for the initial conformity assessment...

          5. 10.5. By way of derogation from Section 6, the manufacturer or its...

      5. PART B PRODUCT VERIFICATION

        1. 11. Product verification shall be understood to be the procedure whereby...

        2. 12. The manufacturer shall take all the measures necessary to ensure...

        3. 13. The manufacturer shall undertake to institute and keep up to...

        4. 14. The notified body shall carry out the appropriate examinations and...

        5. 15. Verification by examination and testing of every product

          1. 15.1. Every device shall be examined individually and the appropriate physical...

          2. 15.2. The notified body shall affix, or have affixed, its identification...

        6. 16. Batch verification in the case of devices incorporating, as an...

        7. 17. Administrative provisions

        8. 18. Application to class IIa devices

          1. 18.1. By way of derogation from Section 11, by virtue of the...

          2. 18.2. The verification conducted by the notified body in accordance with...

          3. 18.3. If the verification referred to in Section 18.2 confirms that the...

          4. 18.4. By way of derogation from Section 17, the manufacturer or its...

    12. ANNEX XII

      CERTIFICATES ISSUED BY A NOTIFIED BODY

      1. CHAPTER I GENERAL REQUIREMENTS

        1. 1. Certificates shall be drawn up in one of the official...

        2. 2. Each certificate shall refer to only one conformity assessment procedure....

        3. 3. Certificates shall only be issued to one manufacturer. The name...

        4. 4. The scope of the certificates shall unambiguously identify the device...

        5. 5. The notified body shall be able to demonstrate on request,...

        6. 6. Certificates shall contain, if applicable, a note that, for the...

        7. 7. EU quality management system certificates and EU quality assurance certificates...

        8. 8. Where a certificate is supplemented, modified or re-issued, the new...

      2. CHAPTER II MINIMUM CONTENT OF THE CERTIFICATES

    13. ANNEX XIII

      PROCEDURE FOR CUSTOM-MADE DEVICES

      1. 1. For custom-made devices, the manufacturer or its authorised representative shall...

      2. 2. The manufacturer shall undertake to keep available for the competent...

      3. 3. The manufacturer shall take all the measures necessary to ensure...

      4. 4. The statement referred to in the introductory part of Section 1...

      5. 5. The manufacturer shall review and document experience gained in the...

    14. ANNEX XIV

      CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP

      1. PART A CLINICAL EVALUATION

        1. 1. To plan, continuously conduct and document a clinical evaluation, manufacturers...

        2. 2. The clinical evaluation shall be thorough and objective, and take...

        3. 3. A clinical evaluation may be based on clinical data relating...

        4. 4. The results of the clinical evaluation and the clinical evidence...

      2. PART B POST-MARKET CLINICAL FOLLOW-UP

        1. 5. PMCF shall be understood to be a continuous process that...

        2. 6. PMCF shall be performed pursuant to a documented method laid...

          1. 6.1. The PMCF plan shall specify the methods and procedures for...

          2. 6.2. The PMCF plan shall include at least:

        3. 7. The manufacturer shall analyse the findings of the PMCF and...

        4. 8. The conclusions of the PMCF evaluation report shall be taken...

    15. ANNEX XV

      CLINICAL INVESTIGATIONS

      1. CHAPTER I GENERAL REQUIREMENTS

        1. 1. Ethical principles

        2. 2. Methods

          1. 2.1. Clinical investigations shall be performed on the basis of an...

          2. 2.2. The procedures used to perform the clinical investigation shall be...

          3. 2.3. The research methodologies used to perform the clinical investigation shall...

          4. 2.4. Clinical investigations shall be performed in accordance with the clinical...

          5. 2.5. All the appropriate technical and functional features of the device,...

          6. 2.6. The endpoints of the clinical investigation shall address the intended...

          7. 2.7. Investigators shall have access to the technical and clinical data...

          8. 2.8. The clinical investigation report, signed by the investigator, shall contain...

      2. CHAPTER II DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION

        1. 1. Application form

        2. 2. Investigator's Brochure

        3. 3. Clinical Investigation Plan

          1. 3.1. General

            1. 3.1.1. Single identification number of the clinical investigation, as referred to...

            2. 3.1.2. Identification of the sponsor — name, address and contact details...

            3. 3.1.3. Information on the principal investigator at each investigational site, the...

            4. 3.1.4. A brief description of how the clinical investigation is financed...

            5. 3.1.5. Overall synopsis of the clinical investigation, in an official Union...

          2. 3.2. Identification and description of the device, including its intended purpose,...

          3. 3.3. Risks and clinical benefits of the device to be examined,...

          4. 3.4. Description of the relevance of the clinical investigation in the...

          5. 3.5. Objectives and hypotheses of the clinical investigation.

          6. 3.6. Design of the clinical investigation with evidence of its scientific...

            1. 3.6.1. General information such as type of investigation with rationale for...

            2. 3.6.2. Information on the investigational device, on any comparator and on...

            3. 3.6.3. Information on subjects, selection criteria, size of investigation population, representativeness...

            4. 3.6.4. Details of measures to be taken to minimise bias, such...

            5. 3.6.5. Description of the clinical procedures and diagnostic methods relating to...

            6. 3.6.6. Monitoring plan.

          7. 3.7. Statistical considerations, with justification, including a power calculation for the...

          8. 3.8. Data management.

          9. 3.9. Information about any amendments to the CIP.

          10. 3.10. Policy regarding follow-up and management of any deviations from the...

          11. 3.11. Accountability regarding the device, in particular control of access to...

          12. 3.12. Statement of compliance with the recognised ethical principles for medical...

          13. 3.13. Description of the Informed consent process.

          14. 3.14. Safety reporting, including definitions of adverse events and serious adverse...

          15. 3.15. Criteria and procedures for follow-up of subjects following the end,...

          16. 3.16. A description of the arrangements for taking care of the...

          17. 3.17. Policy as regards the establishment of the clinical investigation report...

          18. 3.18. List of the technical and functional features of the device,...

          19. 3.19. Bibliography.

        4. 4. Other information

          1. 4.1. A signed statement by the natural or legal person responsible...

          2. 4.2. Where applicable according to national law, copy of the opinion...

          3. 4.3. Proof of insurance cover or indemnification of subjects in case...

          4. 4.4. Documents to be used to obtain informed consent, including the...

          5. 4.5. Description of the arrangements to comply with the applicable rules...

          6. 4.6. Full details of the available technical documentation, for example detailed...

      3. CHAPTER III OTHER OBLIGATIONS OF THE SPONSOR

        1. 1. The sponsor shall undertake to keep available for the competent...

        2. 2. The Sponsor shall have an agreement in place to ensure...

        3. 3. The documentation mentioned in this Annex shall be kept for a...

        4. 4. The Sponsor shall appoint a monitor that is independent from...

        5. 5. The Sponsor shall complete the follow-up of investigation subjects.

        6. 6. The Sponsor shall provide evidence that the investigation is being...

        7. 7. The Sponsor shall prepare a clinical investigation report which includes...

    16. ANNEX XVI

      LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)

      1. 1. Contact lenses or other items intended to be introduced into...

      2. 2. Products intended to be totally or partially introduced into the...

      3. 3. Substances, combinations of substances, or items intended to be used...

      4. 4. Equipment intended to be used to reduce, remove or destroy...

      5. 5. High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet)...

      6. 6. Equipment intended for brain stimulation that apply electrical currents or...

    17. ANNEX XVII

      CORRELATION TABLE

      1. Council Directive 90/385/EEC Council Directive 93/42/EEC This Regulation Article 1(1) Article 1(1) Article 1(1) Article 1(2)...

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