http://www.legislation.gov.uk/id/eur/2017/745

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

Human Readable Interpretation (‘HRI’)

Packaging levels

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 3.1....

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

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 and/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 devices of classes I and IIa packaged and...

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, in the...

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 possible,...

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.Implantable devices:

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

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

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

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

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

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

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

6.4.Configurable devices:

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

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

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

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

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

6.5.Device Software

6.5.1.UDI assignment Criteria

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

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

6.5.4.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 in no way preclude...

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 to...

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 clearly...

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

4.5.4.Pre-clinical evaluation assessment

4.5.5.Clinical evaluation assessment

4.5.6.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

CHAPTER IDEFINITIONS SPECIFIC TO CLASSIFICATION RULES

1.DURATION OF USE

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

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

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

2.INVASIVE AND ACTIVE DEVICES

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

2.2.‘Surgically invasive device’ means:

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

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

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

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

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

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

CHAPTER IIIMPLEMENTING RULES

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

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

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

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

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

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

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

CHAPTER IIICLASSIFICATION RULES

4.NON-INVASIVE DEVICES

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 IIa and class IIb devices,...

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

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

CHAPTER IIASSESSMENT OF THE TECHNICAL DOCUMENTATION

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

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

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

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

5.Specific additional procedures

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

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

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

5.3.1.Tissues or cells of human origin or their derivatives

5.3.2.Tissues or cells of animal origin or their derivatives

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

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

CHAPTER IIIADMINISTRATIVE PROVISIONS

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

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

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...

6.Specific additional procedures

7.Administrative provisions

ANNEX XICONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION

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

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

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

PART APRODUCTION QUALITY ASSURANCE

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

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

6.Quality management system

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

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

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

6.4.Section 2.4 of Annex IX shall apply.

7.Surveillance

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

9.Administrative provisions

10.Application to class IIa devices

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

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

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

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

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

PART BPRODUCT VERIFICATION

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

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

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

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

15.Verification by examination and testing of every product

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

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

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

17.Administrative provisions

18.Application to class IIa devices

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

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

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

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

ANNEX XIICERTIFICATES ISSUED BY A NOTIFIED BODY

CHAPTER IGENERAL REQUIREMENTS

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

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

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

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

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

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

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

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

CHAPTER IIMINIMUM CONTENT OF THE CERTIFICATES

ANNEX XIIIPROCEDURE FOR CUSTOM-MADE DEVICES

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

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

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

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

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

ANNEX XIVCLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP

PART ACLINICAL EVALUATION

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

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

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

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

PART BPOST-MARKET CLINICAL FOLLOW-UP

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

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

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

6.2.The PMCF plan shall include at least:

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

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

ANNEX XVCLINICAL INVESTIGATIONS

CHAPTER IGENERAL REQUIREMENTS

1.Ethical principles

2.Methods

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

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

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

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

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

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

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

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

CHAPTER IIDOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION

CHAPTER IIIOTHER OBLIGATIONS OF THE SPONSOR

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

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

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

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

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

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

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

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

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

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

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

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

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

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

ANNEX XVIICORRELATION TABLE

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) (revoked)

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