Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017on diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU(Text with EEA relevance) (revoked)
CHAPTER IINTRODUCTORY PROVISIONS
Section 1Scope and definitions
Article 1Subject matter and scope
Article 2Definitions
Section 2Regulatory status of products and counselling
Article 3Regulatory status of products
Article 4Genetic information, counselling and informed consent
CHAPTER IIMAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, CE MARKING, FREE MOVEMENT
Article 5Placing on the market and putting into service
Article 6Distance sales
Article 7Claims
Article 8Use of harmonised standards
Article 9Common specifications
Article 10General obligations of manufacturers
Article 11Authorised representative
Article 12Change of authorised representative
Article 13General obligations of importers
Article 14General obligations of distributors
Article 15Person responsible for regulatory compliance
Article 16Cases in which obligations of manufacturers apply to importers, distributors or other persons
Article 17EU declaration of conformity
Article 18CE marking of conformity
Article 19Devices for special purposes
Article 20Parts and components
Article 21Free movement
CHAPTER IIIIDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES
Article 22Identification within the supply chain
Article 23Medical devices nomenclature
Article 24Unique Device Identification system
Article 25UDI database
Article 26Registration of devices
Article 27Electronic system for registration of economic operators
Article 28Registration of manufacturers, authorised representatives and importers
Article 29Summary of safety and performance
Article 30European database on medical devices
CHAPTER IVNOTIFIED BODIES
Article 31Authorities responsible for notified bodies
Article 32Requirements relating to notified bodies
Article 33Subsidiaries and subcontracting
Article 34Application by conformity assessment bodies for designation
Article 35Assessment of the application
Article 36Nomination of experts for joint assessment of applications for notification
Article 37Language requirements
Article 38Designation and notification procedure
Article 39Identification number and list of notified bodies
Article 40Monitoring and re-assessment of notified bodies
Article 41Review of notified body assessment of technical documentation and performance evaluation documentation
Article 42Changes to designations and notifications
Article 43Challenge to the competence of notified bodies
Article 44Peer review and exchange of experience between authorities responsible for notified bodies
Article 45Coordination of notified bodies
Article 46List of standard fees
CHAPTER VCLASSIFICATION AND CONFORMITY ASSESSMENT
Section 1Classification
Article 47Classification of devices
Section 2Conformity assessment
Article 48Conformity assessment procedures
Article 49Involvement of notified bodies in conformity assessment procedures
Article 50Mechanism for scrutiny of conformity assessments of class D devices
Article 51Certificates of conformity
Article 52Electronic system on notified bodies and on certificates of conformity
Article 53Voluntary change of notified body
Article 54Derogation from the conformity assessment procedures
Article 55Certificate of free sale
CHAPTER VICLINICAL EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIES
Article 56Performance evaluation and clinical evidence
Article 57General requirements regarding performance studies
Article 58Additional requirements for certain performance studies
Article 59Informed consent
Article 60Performance studies on incapacitated subjects
Article 61Performance studies on minors
Article 62Performance studies on pregnant or breastfeeding women
Article 63Additional national measures
Article 64Performance studies in emergency situations
Article 65Damage compensation
Article 66Application for performance studies
Article 67Assessment by Member States
Article 68Conduct of a performance study
Article 69Electronic system on performance studies
Article 70Performance studies regarding devices bearing the CE marking
Article 71Substantial modifications to performance studies
Article 72Corrective measures to be taken by Member States and information exchange between Member States on performance studies
Article 73Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination
Article 74Coordinated assessment procedure for performance studies
Article 75Review of the coordinated assessment procedure
Article 76Recording and reporting of adverse events that occur during performance studies
Article 77Implementing acts
CHAPTER VIIPOST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
Section 1Post-market surveillance
Article 78Post-market surveillance system of the manufacturer
Article 79Post-market surveillance plan
Article 80Post-market surveillance report
Article 81Periodic safety update report
Section 2Vigilance
Article 82Reporting of serious incidents and field safety corrective actions
Article 83Trend reporting
Article 84Analysis of serious incidents and field safety corrective actions
Article 85Analysis of vigilance data
Article 86Implementing acts
Article 87Electronic system on vigilance and post-market surveillance
Section 3Market surveillance
Article 88Market surveillance activities
Article 89Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
Article 90Procedure for dealing with devices presenting an unacceptable risk to health and safety
Article 91Procedure for evaluating national measures at Union level
Article 92Other non-compliance
Article 93Preventive health protection measures
Article 94Good administrative practice
Article 95Electronic system on market surveillance
CHAPTER VIIICOOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EU REFERENCE LABORATORIES AND DEVICE REGISTERS
Article 96Competent authorities
Article 97Cooperation
Article 98Medical Device Coordination Group
Article 99Tasks of the MDCG
Article 100The European Union reference laboratories
Article 101Device registers and databanks
CHAPTER IXCONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
Article 102Confidentiality
Article 103Data protection
Article 104Levying of fees
Article 105Funding of activities related to designation and monitoring of notified bodies
Article 106Penalties
CHAPTER XFINAL PROVISIONS
Article 107Committee procedure
Article 108Exercise of the delegation
Article 109Separate delegated acts for different delegated powers
Article 110Transitional provisions
Article 111Evaluation
Article 112Repeal
Article 113Entry into force and date of application
ANNEXES
ANNEX IGENERAL SAFETY AND PERFORMANCE REQUIREMENTS
CHAPTER IGENERAL REQUIREMENTS
1.Devices shall achieve the performance intended by their manufacturer and...
2.The requirement in this Annex to reduce risks as far...
3.Manufacturers shall establish, implement, document and maintain a risk management...
4.Risk control measures adopted by manufacturers for the design and...
5.In eliminating or reducing risks related to use error, the...
6.The characteristics and performance of a device shall not be...
7.Devices shall be designed, manufactured and packaged in such a...
8.All known and foreseeable risks, and any undesirable effects shall...
CHAPTER IIREQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTURE
9.Performance characteristics
9.1.Devices shall be designed and manufactured in such a way...
9.2.The performance characteristics of the device shall be maintained during...
9.3.Where the performance of devices depends on the use of...
9.4.The characteristics and performances of the device shall be specifically...
10.Chemical, physical and biological properties
10.1.Devices shall be designed and manufactured in such a way...
10.2.Devices shall be designed, manufactured and packaged in such a...
10.3.Devices shall be designed and manufactured in such a way...
10.4.Devices shall be designed and manufactured in such a way...
11.Infection and microbial contamination
11.1.Devices and their manufacturing processes shall be designed in such...
11.2.Devices labelled either as sterile or as having a specific...
11.3.Devices labelled as sterile shall be processed, manufactured, packaged and,...
11.4.Devices intended to be sterilised shall be manufactured and packaged...
11.5.Packaging systems for non-sterile devices shall maintain the integrity and...
11.6.The labelling of the device shall distinguish between identical or...
12.Devices incorporating materials of biological origin
13.Construction of devices and interaction with their environment
13.1.If the device is intended for use in combination with...
13.2.Devices shall be designed and manufactured in such a way...
13.3.Devices shall be designed and manufactured in such a way...
13.4.Devices shall be designed and manufactured in such a way...
13.5.Devices that are intended to be operated together with other...
13.6.Devices shall be designed and manufactured in such a way...
13.7The measuring, monitoring or display scale (including colour change and...
14.Devices with a measuring function
14.1.Devices having a primary analytical measuring function shall be designed...
14.2.The measurements made by devices with a measuring function shall...
15.Protection against radiation
15.1.Devices shall be designed, manufactured and packaged in such a...
15.2.When devices are intended to emit hazardous, or potentially hazardous,...
15.3.The operating instructions for devices emitting hazardous or potentially hazardous...
16.Electronic programmable systems — devices that incorporate electronic programmable systems...
16.1.Devices that incorporate electronic programmable systems, including software, or software...
16.2.For devices that incorporate software or for software that are...
16.3.Software referred to in this Section that is intended to...
16.4.Manufacturers shall set out minimum requirements concerning hardware, IT networks...
17.Devices connected to or equipped with an energy source
17.1.For devices connected to or equipped with an energy source,...
17.2.Devices where the safety of the patient depends on an...
17.3.Devices shall be designed and manufactured in such a way...
17.4.Devices shall be designed and manufactured in such a way...
17.5.Devices shall be designed and manufactured in such a way...
18.Protection against mechanical and thermal risks
18.1.Devices shall be designed and manufactured in such a way...
18.2.Devices shall be sufficiently stable under the foreseen operating conditions....
18.3.Where there are risks due to the presence of moving...
18.4.Devices shall be designed and manufactured in such a way...
18.5.Devices shall be designed and manufactured in such a way...
18.6.Terminals and connectors to the electricity, gas or hydraulic and...
18.7.Errors likely to be made when fitting or refitting certain...
18.8.Accessible parts of devices (excluding the parts or areas intended...
19.Protection against the risks posed by devices intended for self-testing...
19.1.Devices intended for self-testing or near-patient testing shall be designed...
19.2.Devices intended for self-testing or near-patient testing shall be designed...
19.3.Devices intended for self-testing and near-patient testing shall, where feasible,...
CHAPTER IIIREQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE
20.Label and instructions for use
20.1.General requirements regarding the information supplied by the manufacturer
20.2.Information on the label
20.3.Information on the packaging which maintains the sterile condition of...
20.4.Information in the instructions for use
20.4.1.The instructions for use shall contain all of the following...
20.4.2In addition, the instructions for use for devices intended for...
ANNEX IITECHNICAL DOCUMENTATION
The technical documentation and, if applicable, the summary thereof to...
1.DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
1.1.Device description and specification
1.2.Reference to previous and similar generations of the device
2.INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
3.DESIGN AND MANUFACTURING INFORMATION
3.1.Design information
3.2.Manufacturing information
4.GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
5.BENFIT-RISK ANALYSIS AND RISK MANAGEMENT
6.PRODUCT VERIFICATION AND VALIDATION
ANNEX IIITECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
The technical documentation on post-market surveillance to be drawn up...
1.The post-market surveillance plan drawn up in accordance with Article...
2.The PSUR referred to in Article 81 and the post-market...
ANNEX IVEU DECLARATION OF CONFORMITY
ANNEX VCE MARKING OF CONFORMITY
1.The CE marking shall consist of the initials ‘CE’ taking...
2.If the CE marking is reduced or enlarged the proportions...
3.The various components of the CE marking shall have substantially...
ANNEX VIINFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26 AND THE UDI SYSTEM
PART AINFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND...PART BCORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE...PART CTHE UDI SYSTEM
1.Definitions
Automatic identification and data capture (‘AIDC’)
Basic UDI-DI
Unit of Use DI
Configurable device
Configuration
UDI-DI
Human Readable Interpretation (HRI)
Packaging levels
Production Identifier (UDI-PI)
Radio Frequency Identification (‘RFID’)
Shipping containers
Unique Device Identifier (‘UDI’)
UDI carrier
2.General requirements
2.1.The affixing of the UDI is an additional requirement —...
2.2.The manufacturer shall assign and maintain unique UDIs for its...
2.3.Only the manufacturer may place the UDI on the device...
2.4.Only coding standards provided by issuing entities designated by the...
3.The UDI
3.1.A UDI shall be assigned to the device itself or...
3.2.Shipping containers shall be exempted from the requirement in Section...
3.3.The UDI shall contain two parts: a UDI-DI and a...
3.4.The UDI-DI shall be unique at each level of device...
3.5.If a lot number, serial number, software identification or expiry...
3.6.Each component that is considered to be a device and...
3.7.Kits shall be assigned and bear their own UDI.
3.8.The manufacturer shall assign the UDI to a device following...
3.9.A new UDI-DI shall be required whenever there is a...
3.10.Manufacturers that repackage or relabel devices with their own label...
4.UDI carrier
4.1.The UDI carrier (AIDC and HRI representation of the UDI)...
4.2.In the event of there being significant space constraints on...
4.3.For single use class A and class B devices packaged...
4.4.For devices exclusively intended for retail point of sale, the...
4.5.When AIDC carriers other than the UDI carrier are part...
4.6.If linear bar codes are used, the UDI-DI and UDI-PI...
4.7.If there are significant constraints limiting the use of both...
4.8.The HRI format shall follow the rules of the UDI...
4.9.If the manufacturer is using RFID technology, a linear or...
4.10.Devices that are reusable shall bear a UDI carrier on...
4.11.The UDI carrier shall be readable during normal use and...
4.12.If the UDI carrier is readily readable or scannable through...
4.13.In the case of single finished devices made up of...
4.14.The UDI carrier shall be placed in a manner such...
4.15.Bar code carriers that include both a UDI-DI and a...
5.General principles of the UDI database
5.1.The UDI database shall support the use of all core...
5.2.Manufacturers shall be responsible for the initial submission and updates...
5.3.Appropriate methods/procedures for validation of the data provided shall be...
5.4.Manufacturers shall periodically verify the correctness of all of the...
5.5.The presence of the device UDI-DI in the UDI database...
5.6.The database shall allow for the linking of all the...
5.7.The data for new UDI-DIs shall be available at the...
5.8.Manufacturers shall update the relevant UDI database record within 30...
5.9.Internationally accepted standards for data submission and updates shall, wherever...
5.10.The user interface of the UDI database shall be available...
5.11.Data relating to devices that are no longer available on...
6.Rules for specific device types
6.1.Reusable devices that are part of kits and that require...
6.1.1.The UDI of such devices shall be placed on the...
6.1.2.The UDI-PI characteristics such as the lot or serial number...
6.2.Device software
6.2.1.UDI assignment Criteria
6.2.2.A new UDI-DI shall be required whenever there is a...
6.2.3.Minor software revisions shall require a new UDI-PI and not...
6.2.4.UDI placement criteria for software
ANNEX VIIREQUIREMENTS TO BE MET BY NOTIFIED BODIES
1.ORGANISATIONAL AND GENERAL REQUIREMENTS
1.1.Legal status and organisational structure
1.1.1.Each notified body shall be established under the national law...
1.1.2.If the notified body is a legal entity that is...
1.1.3.If a notified body wholly or partly owns legal entities...
1.1.4.The organisational structure, allocation of responsibilities, reporting lines and operation...
1.1.5.The notified body shall clearly document its organisational structure and...
1.1.6.The notified body shall identify the persons in top-level management...
1.2.Independence and impartiality
1.2.1.The notified body shall be a third-party body that is...
1.2.2.The notified body shall be organised and operated so as...
1.2.3.The notified body, its top-level management and the personnel responsible...
1.2.4.Involvement in consultancy services in the field of devices prior...
1.2.5.The impartiality of notified bodies, of their top-level management and...
1.2.6.If a notified body is owned by a public entity...
1.2.7.The notified body shall ensure and document that the activities...
1.2.8.The notified body shall operate in accordance with a set...
1.2.9.The requirements laid down in this Section shall in no...
1.3.Confidentiality
1.3.1.The notified body shall have documented procedures in place ensuring...
1.3.2.The personnel of a notified body shall observe professional secrecy...
1.4.Liability
1.4.1.The notified body shall take out appropriate liability insurance for...
1.4.2.The scope and overall financial value of the liability insurance...
1.5.Financial requirements
1.6.Participation in coordination activities
1.6.1.The notified body shall participate in, or ensure that its...
1.6.2.The notified body shall take into consideration guidance and best...
2.QUALITY MANAGEMENT REQUIREMENTS
2.1.The notified body shall establish, document, implement, maintain and operate...
2.2.The quality management system of the notified body shall address...
2.3.The top-level management of the notified body shall ensure that...
2.4.The notified body shall require all personnel to formally commit...
3.RESOURCE REQUIREMENTS
3.1.General
3.1.1.Notified bodies shall be capable of carrying out all the...
3.1.2.The notified body shall ensure that personnel involved in conformity...
3.1.3.The notified body shall clearly document the extent and limits...
3.2.Qualification criteria in relation to personnel
3.2.1.The notified body shall establish and document qualification criteria and...
3.2.2.The qualification criteria referred to in Section 3.2.1 shall refer...
3.2.3.The personnel responsible for establishing qualification criteria and for authorising...
3.2.4.The notified body shall have permanent availability of personnel with...
3.2.5.The personnel responsible for carrying out product-related reviews, (product reviewers),...
3.2.6.The personnel responsible for carrying out audits of the manufacturer's...
3.2.7.The personnel with overall responsibility for final reviews and decision-making...
3.3.Documentation of qualification, training and authorisation of personnel
3.3.1.The notified body shall have a procedure in place to...
3.3.2.For all of its personnel referred to in Sections 3.2.3...
3.4.Subcontractors and external experts
3.4.1.Notified bodies may, without prejudice to Section 3.2, subcontract certain...
3.4.2.Where a notified body subcontracts certain conformity assessment activities either...
3.4.3.Where subcontractors or external experts are used in the context...
3.5.Monitoring of competences, training and exchange of experience
3.5.1.The notified body shall establish procedures for the initial evaluation...
3.5.2.Notified bodies shall review at regular intervals, the competence of...
4.PROCESS REQUIREMENTS
4.1.General
4.2.Notified body quotations and pre-application activities
4.3.Application review and contract
4.4.Allocation of resources
4.5.Conformity assessment activities
4.5.1.General
4.5.2.Quality management system auditing
4.5.3.Product verification
Assessment of the technical documentation
Type-examinations
Verification by examination and testing of every product batch
4.5.4.Performance evaluation assessment
4.5.5.Specific Procedures
4.6.Reporting
4.7.Final review
4.8.Decisions and certifications
4.9.Changes and modifications
4.10.Surveillance activities and post-certification monitoring
4.11.Re-certification
ANNEX VIIICLASSIFICATION RULES
1.IMPLEMENTING RULES
1.1.Application of the classification rules shall be governed by the...
1.2.If the device in question is intended to be used...
1.3.Accessories for an in vitro diagnostic medical device shall be...
1.4.Software, which drives a device or influences the use of...
1.5.Calibrators intended to be used with a device shall be...
1.6.Control materials with quantitative or qualitative assigned values intended for...
1.7.The manufacturer shall take into consideration all classification and implementation...
1.8.Where a manufacturer states multiple intended purposes for a device,...
1.9.If several classification rules apply to the same device, the...
1.10.Each of the classification rules shall apply to first line...
2.CLASSIFICATION RULES
2.1.Rule 1
2.2.Rule 2
2.3.Rule 3
2.4.Rule 4
2.5.Rule 5
2.6.Rule 6
2.7.Rule 7
ANNEX IXCONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION
CHAPTER IQUALITY MANAGEMENT SYSTEM
1.The manufacturer shall establish, document and implement a quality management...
2.Quality management system assessment
2.1.The manufacturer shall lodge an application for assessment of its...
2.2.Implementation of the quality management system shall ensure compliance with...
2.3.Audit
2.4.The manufacturer in question shall inform the notified body which...
3.Surveillance assessment
3.1.The aim of surveillance is to ensure that the manufacturer...
3.2.The manufacturer shall give authorisation to the notified body to...
3.3.Notified bodies shall periodically, at least once every 12 months,...
3.4.The notified body shall randomly perform at least once every...
3.5.In the case of class B and C devices, the...
3.6.Notified bodies shall ensure that the composition of the assessment...
3.7.If the notified body finds a divergence between the sample...
CHAPTER IIASSESSMENT OF THE TECHNICAL DOCUMENTATION
4.Assessment of the technical documentation of class B, C and...
4.1.In addition to the obligation laid down in Section 2,...
4.2.The application shall describe the design, manufacture and performance of...
4.3.The notified body shall assess the technical documentation using staff...
4.4.The notified body shall review the clinical evidence presented by...
4.5.The notified body shall, in circumstances in which the clinical...
4.6.The notified body shall verify that the clinical evidence and...
4.7.Based on its assessment of the clinical evidence, the notified...
4.8.The notified body shall clearly document the outcome of its...
4.9.Before issuing an EU technical documentation assessment certificate, the notified...
4.10.The notified body shall provide the manufacturer with a report...
4.11.Changes to the approved device shall require approval from the...
4.12.To verify conformity of manufactured class D devices, the manufacturer...
4.13.The manufacturer may place the devices on the market, unless...
5.Assessment of the technical documentation of specific types of devices...
5.1.Assessment of the technical documentation of class B, C and...
5.2.Assessment of the technical documentation of companion diagnostics
CHAPTER IIIADMINISTRATIVE PROVISIONS
6.The manufacturer or, where the manufacturer does not have a...
7.Each Member State shall require that the documentation referred to...
ANNEX XCONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
1.EU type-examination is the procedure whereby a notified body ascertains...
2.Application
3.Assessment
4.Certificate
5.Changes to the type
5.1.The applicant shall inform the notified body which issued the...
5.2.Changes to the approved device including limitations of its intended...
5.3.Changes to the intended purpose and conditions of use of...
5.4.Where the changes could affect the performance claimed by the...
5.5.Where the changes affect the performance or the intended use...
6.Administrative provisions
ANNEX XICONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE
1.The manufacturer shall ensure that the quality management system approved...
2.When the manufacturer fulfils the obligations laid down in Section...
3.Quality management system
3.1.The manufacturer shall lodge an application for assessment of its...
3.2.Implementation of the quality management system shall be such as...
3.3.The first and second paragraphs of Section 2.3 of Annex...
3.4.Section 2.4 of Annex IX shall apply.
4.Surveillance
5.Verification of manufactured class D devices
5.1.In the case of class D devices, the manufacturer shall...
5.2.The manufacturer may place the devices on the market, unless...
6.Administrative provisions
ANNEX XIICERTIFICATES ISSUED BY A NOTIFIED BODY
CHAPTER IGENERAL REQUIREMENTS
CHAPTER IIMINIMUM CONTENT OF THE CERTIFICATES
ANNEX XIIIPERFORMANCE EVALUATION, PERFORMANCE STUDIES AND POST-MARKET PERFORMANCE FOLLOW-UP
PART APERFORMANCE EVALUATION AND PERFORMANCE STUDIES
1.PERFORMANCE EVALUATION
2.CLINICAL PERFORMANCE STUDIES
2.1.Purpose of clinical performance studies
2.2.Ethical considerations for clinical performance studies
2.3.Methods for clinical performance studies
2.3.1.Clinical performance study design type
2.3.2.Clinical performance study plan
2.3.3.Clinical performance study report
3.OTHER PERFORMANCE STUDIES
PART BPOST-MARKET PERFORMANCE FOLLOW-UP
4.PMPF shall be understood to be a continuous process that...
5.PMPF shall be performed pursuant to a documented method laid...
5.1.The PMPF plan shall specify the methods and procedures for...
5.2.The PMPF plan shall include at least:
6.The manufacturer shall analyse the findings of the PMPF and...
7.The conclusions of the PMPF evaluation report shall be taken...
8.If PMPF is not deemed appropriate for a specific device...
ANNEX XIVINTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES
CHAPTER IDOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND...
CHAPTER IIOTHER OBLIGATIONS OF THE SPONSOR
ANNEX XVCORRELATION TABLE

Regulation (EU) 2017/746 of the European Parliament and of the Council

of 5 April 2017

on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

(Text with EEA relevance) (revoked)

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .