Regulation (EU) 2017/746 of the European Parliament and of the CouncilShow full title

1. Introductory Text

2. CHAPTER I INTRODUCTORY PROVISIONS

   1. Section 1 Scope and definitions

      1. Article 1. Subject matter and scope

      2. Article 2. Definitions

   2. Section 2 Regulatory status of products and counselling

      1. Article 3. Regulatory status of products

      2. Article 4. Genetic information, counselling and informed consent

3. CHAPTER II MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, 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. EU declaration of conformity

   14. Article 18. CE marking of conformity

   15. Article 19. Devices for special purposes

   16. Article 20. Parts and components

   17. Article 21. 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 22. Identification within the supply chain

   2. Article 23. Medical devices nomenclature

   3. Article 24. Unique Device Identification system

   4. Article 25. UDI database

   5. Article 26. Registration of devices

   6. Article 27. Electronic system for registration of economic operators

   7. Article 28. Registration of manufacturers, authorised representatives and importers

   8. Article 29. Summary of safety and performance

   9. Article 30. European database on medical devices

5. CHAPTER IV NOTIFIED BODIES

   1. Article 31. Authorities responsible for notified bodies

   2. Article 32. Requirements relating to notified bodies

   3. Article 33. Subsidiaries and subcontracting

   4. Article 34. Application by conformity assessment bodies for designation

   5. Article 35. Assessment of the application

   6. Article 36. Nomination of experts for joint assessment of applications for notification

   7. Article 37. Language requirements

   8. Article 38. Designation and notification procedure

   9. Article 39. Identification number and list of notified bodies

   10. Article 40. Monitoring and re-assessment of notified bodies

   11. Article 41. Review of notified body assessment of technical documentation and performance evaluation documentation

   12. Article 42. Changes to designations and notifications

   13. Article 43. Challenge to the competence of notified bodies

   14. Article 44. Peer review and exchange of experience between authorities responsible for notified bodies

   15. Article 45. Coordination of notified bodies

   16. Article 46. List of standard fees

6. CHAPTER V CLASSIFICATION AND CONFORMITY ASSESSMENT

   1. Section 1 Classification

      1. Article 47. Classification of devices

   2. Section 2 Conformity assessment

      1. Article 48. Conformity assessment procedures

      2. Article 49. Involvement of notified bodies in conformity assessment procedures

      3. Article 50. Mechanism for scrutiny of conformity assessments of class D devices

      4. Article 51. Certificates of conformity

      5. Article 52. Electronic system on notified bodies and on certificates of conformity

      6. Article 53. Voluntary change of notified body

      7. Article 54. Derogation from the conformity assessment procedures

      8. Article 55. Certificate of free sale

7. CHAPTER VI CLINICAL EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIES

   1. Article 56. Performance evaluation and clinical evidence

   2. Article 57. General requirements regarding performance studies

   3. Article 58. Additional requirements for certain performance studies

   4. Article 59. Informed consent

   5. Article 60. Performance studies on incapacitated subjects

   6. Article 61. Performance studies on minors

   7. Article 62. Performance studies on pregnant or breastfeeding women

   8. Article 63. Additional national measures

   9. Article 64. Performance studies in emergency situations

   10. Article 65. Damage compensation

   11. Article 66. Application for performance studies

   12. Article 67. Assessment by Member States

   13. Article 68. Conduct of a performance study

   14. Article 69. Electronic system on performance studies

   15. Article 70. Performance studies regarding devices bearing the CE marking

   16. Article 71. Substantial modifications to performance studies

   17. Article 72. Corrective measures to be taken by Member States and information exchange between Member States on performance studies

   18. Article 73. Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination

   19. Article 74. Coordinated assessment procedure for performance studies

   20. Article 75. Review of the coordinated assessment procedure

   21. Article 76. Recording and reporting of adverse events that occur during performance studies

   22. Article 77. Implementing acts

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

   1. Section 1 Post-market surveillance

      1. Article 78. Post-market surveillance system of the manufacturer

      2. Article 79. Post-market surveillance plan

      3. Article 80. Post-market surveillance report

      4. Article 81. Periodic safety update report

   2. Section 2 Vigilance

      1. Article 82. Reporting of serious incidents and field safety corrective actions

      2. Article 83. Trend reporting

      3. Article 84. Analysis of serious incidents and field safety corrective actions

      4. Article 85. Analysis of vigilance data

      5. Article 86. Implementing acts

      6. Article 87. Electronic system on vigilance and post-market surveillance

   3. Section 3 Market surveillance

      1. Article 88. Market surveillance activities

      2. Article 89. Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance

      3. Article 90. Procedure for dealing with devices presenting an unacceptable risk to health and safety

      4. Article 91. Procedure for evaluating national measures at Union level

      5. Article 92. Other non-compliance

      6. Article 93. Preventive health protection measures

      7. Article 94. Good administrative practice

      8. Article 95. Electronic system on market surveillance

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

   1. Article 96. Competent authorities

   2. Article 97. Cooperation

   3. Article 98. Medical Device Coordination Group

   4. Article 99. Tasks of the MDCG

   5. Article 100. The European Union reference laboratories

   6. Article 101. Device registers and databanks

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

    1. Article 102. Confidentiality

    2. Article 103. Data protection

    3. Article 104. Levying of fees

    4. Article 105. Funding of activities related to designation and monitoring of notified bodies

    5. Article 106. Penalties

11. CHAPTER X FINAL PROVISIONS

    1. Article 107. Committee procedure

    2. Article 108. Exercise of the delegation

    3. Article 109. Separate delegated acts for different delegated powers

    4. Article 110. Transitional provisions

    5. Article 111. Evaluation

    6. Article 112. Repeal

    7. Article 113. Entry into force and date of application

12. Signature

13. 1. ANNEXES

       1. I General safety and performance requirements

       2. II Technical documentation

       3. III Technical documentation on post-market surveillance

       4. IV EU declaration of conformity

       5. V CE marking of conformity

       6. VI Information to be submitted upon the registration of devices and...

       7. VII Requirements to be met by notified bodies

       8. VIII Classification rules

       9. IX Conformity assessment based on a quality management system and on...

       10. X Conformity assessment based on type examination

       11. XI Conformity assessment based on production quality assurance

       12. XII Certificates issued by a notified body

       13. XIII Performance evaluation, performance studies and post-market performance follow-up

       14. XIV Interventional clinical performance studies and certain other performance studies

       15. XV Correlation table

    2. 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...

          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 effects shall...

       2. CHAPTER II REQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTURE

          1. 9. Performance characteristics

             1. 9.1. Devices shall be designed and manufactured in such a way...

             2. 9.2. The performance characteristics of the device shall be maintained during...

             3. 9.3. Where the performance of devices depends on the use of...

             4. 9.4. The characteristics and performances of the device shall be specifically...

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

          3. 11. Infection and microbial contamination

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

             2. 11.2. Devices labelled either as sterile or as having a specific...

             3. 11.3. Devices labelled as sterile shall be processed, manufactured, packaged and,...

             4. 11.4. Devices intended to be sterilised shall be manufactured and packaged...

             5. 11.5. Packaging systems for non-sterile devices shall maintain the integrity and...

             6. 11.6. The labelling of the device shall distinguish between identical or...

          4. 12. Devices incorporating materials of biological origin

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

             1. 13.1. If the device is intended for use in combination with...

             2. 13.2. Devices shall be designed and manufactured in such a way...

             3. 13.3. Devices shall be designed and manufactured in such a way...

             4. 13.4. Devices shall be designed and manufactured in such a way...

             5. 13.5. Devices that are intended to be operated together with other...

             6. 13.6. Devices shall be designed and manufactured in such a way...

             7. 13.7 The measuring, monitoring or display scale (including colour change and...

          6. 14. Devices with a measuring function

             1. 14.1. Devices having a primary analytical measuring function shall be designed...

             2. 14.2. The measurements made by devices with a measuring function shall...

          7. 15. Protection against radiation

             1. 15.1. Devices shall be designed, manufactured and packaged in such a...

             2. 15.2. When devices are intended to emit hazardous, or potentially hazardous,...

             3. 15.3. The operating instructions for devices emitting hazardous or potentially hazardous...

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

             1. 16.1. Devices that incorporate electronic programmable systems, including software, or software...

             2. 16.2. For devices that incorporate software or for software that are...

             3. 16.3. Software referred to in this Section that is intended to...

             4. 16.4. Manufacturers shall set out minimum requirements concerning hardware, IT networks...

          9. 17. Devices connected to or equipped with an energy source

             1. 17.1. For devices connected to or equipped with an energy source,...

             2. 17.2. Devices where the safety of the patient depends on an...

             3. 17.3. Devices shall be designed and manufactured in such a way...

             4. 17.4. Devices shall be designed and manufactured in such a way...

             5. 17.5. Devices shall be designed and manufactured in such a way...

          10. 18. Protection against mechanical and thermal risks

              1. 18.1. Devices shall be designed and manufactured in such a way...

              2. 18.2. Devices shall be sufficiently stable under the foreseen operating conditions....

              3. 18.3. Where there are risks due to the presence of moving...

              4. 18.4. Devices shall be designed and manufactured in such a way...

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

              6. 18.6. Terminals and connectors to the electricity, gas or hydraulic and...

              7. 18.7. Errors likely to be made when fitting or refitting certain...

              8. 18.8. Accessible parts of devices (excluding the parts or areas intended...

          11. 19. Protection against the risks posed by devices intended for self-testing...

              1. 19.1. Devices intended for self-testing or near-patient testing shall be designed...

              2. 19.2. Devices intended for self-testing or near-patient testing shall be designed...

              3. 19.3. Devices intended for self-testing and near-patient testing shall, where feasible,...

       3. CHAPTER III REQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE

          1. 20. Label and instructions for use

             1. 20.1. General requirements regarding the information supplied by the manufacturer

             2. 20.2. Information on the label

             3. 20.3. Information on the packaging which maintains the sterile condition of...

             4. 20.4. Information in the instructions for use

                1. 20.4.1. The instructions for use shall contain all of the following...

                2. 20.4.2 In addition, the instructions for use for devices intended for...

    3. 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

          1. 3.1. Design information

          2. 3.2. Manufacturing information

       5. 4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

       6. 5. BENFIT-RISK ANALYSIS AND RISK MANAGEMENT

       7. 6. PRODUCT VERIFICATION AND VALIDATION

          1. 6.1. Information on analytical performance of the device

             1. 6.1.1. Specimen type

             2. 6.1.2. Analytical performance characteristics

                1. 6.1.2.1. Accuracy of measurement

                2. 6.1.2.2. Analytical sensitivity

                3. 6.1.2.3. Analytical specificity

                4. 6.1.2.4. Metrological traceability of calibrator and control material values

                5. 6.1.2.5. Measuring range of the assay

                6. 6.1.2.6. Definition of assay cut-off

             3. 6.1.3. The analytical performance report referred to in Annex XIII.

          2. 6.2. Information on clinical performance and clinical evidence. Performance Evaluation Report...

          3. 6.3. Stability (excluding specimen stability)

             1. 6.3.1. Claimed shelf-life

             2. 6.3.2. In-use stability

             3. 6.3.3. Shipping stability

          4. 6.4. Software verification and validation

          5. 6.5. Additional information required in specific cases

    4. 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...

       3. 2. The PSUR referred to in Article 81 and the post-market...

    5. ANNEX IV

       EU DECLARATION OF CONFORMITY

       1. The EU declaration of conformity shall contain the following information:...

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

    6. 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...

    7. ANNEX VI

       INFORMATION 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

       1. PART A INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28

          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 TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26

       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. Production Identifier (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. 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. Kits shall be assigned and bear their own UDI.

             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 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 class A and class B devices packaged...

             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 scannable through...

             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...

             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. Reusable devices that are part of kits and that require...

                1. 6.1.1. The UDI of such devices shall be placed on the...

                2. 6.1.2. The UDI-PI characteristics such as the lot or serial number...

             2. 6.2. Device software

                1. 6.2.1. UDI assignment Criteria

                2. 6.2.2. A new UDI-DI shall be required whenever there is a...

                3. 6.2.3. Minor software revisions shall require a new UDI-PI and not...

                4. 6.2.4. UDI placement criteria for software

    8. 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 shall in no...

          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...

             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...

             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 batch

             4. 4.5.4. Performance evaluation assessment

             5. 4.5.5. 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

    9. ANNEX VIII

       CLASSIFICATION RULES

       1. 1. IMPLEMENTING RULES

          1. 1.1. Application of the classification rules shall be governed by the...

          2. 1.2. If the device in question is intended to be used...

          3. 1.3. Accessories for an in vitro diagnostic medical device shall be...

          4. 1.4. Software, which drives a device or influences the use of...

          5. 1.5. Calibrators intended to be used with a device shall be...

          6. 1.6. Control materials with quantitative or qualitative assigned values intended for...

          7. 1.7. The manufacturer shall take into consideration all classification and implementation...

          8. 1.8. Where a manufacturer states multiple intended purposes for a device,...

          9. 1.9. If several classification rules apply to the same device, the...

          10. 1.10. Each of the classification rules shall apply to first line...

       2. 2. CLASSIFICATION RULES

          1. 2.1. Rule 1

          2. 2.2. Rule 2

          3. 2.3. Rule 3

          4. 2.4. Rule 4

          5. 2.5. Rule 5

          6. 2.6. Rule 6

          7. 2.7. Rule 7

    10. 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 applicable to class C and class D devices...

              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 C devices, the surveillance assessment...

              6. 3.6. Notified bodies shall ensure that the composition of the assessment...

              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 of class B, C and...

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

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

              3. 4.3. The notified body shall examine the application by 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. Before issuing an EU technical documentation assessment certificate, the notified...

              10. 4.10. The notified body shall provide the manufacturer with a report...

              11. 4.11. Changes to the approved device shall require approval from the...

              12. 4.12. To verify conformity of manufactured class D devices, the manufacturer...

              13. 4.13. The manufacturer may place the devices on the market, unless...

           2. 5. Assessment of the technical documentation of specific types of devices...

              1. 5.1. Assessment of the technical documentation of class B, C and...

              2. 5.2. Assessment of the technical documentation of companion diagnostics

        3. CHAPTER III ADMINISTRATIVE PROVISIONS

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

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

    11. 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...

           4. 5.4. Where the changes could affect the performance claimed by the...

           5. 5.5. Where the changes affect the performance or the intended use...

        6. 6. Administrative provisions

    12. ANNEX XI

        CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE

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

        2. 2. When the manufacturer fulfils the obligations laid down in Section...

        3. 3. Quality management system

           1. 3.1. The manufacturer shall lodge an application for assessment of its...

           2. 3.2. Implementation of the quality management system shall be such as...

           3. 3.3. The first and second paragraphs of Section 2.3 of Annex...

           4. 3.4. Section 2.4 of Annex IX shall apply.

        4. 4. Surveillance

        5. 5. Verification of manufactured class D devices

           1. 5.1. In the case of class D devices, the manufacturer shall...

           2. 5.2. The manufacturer may place the devices on the market, unless...

        6. 6. Administrative provisions

    13. ANNEX XII

        CERTIFICATES ISSUED BY A NOTIFIED BODY

        1. CHAPTER I GENERAL REQUIREMENTS

        2. CHAPTER II MINIMUM CONTENT OF THE CERTIFICATES

    14. ANNEX XIII

        PERFORMANCE EVALUATION, PERFORMANCE STUDIES AND POST-MARKET PERFORMANCE FOLLOW-UP

        1. PART A PERFORMANCE EVALUATION AND PERFORMANCE STUDIES

           1. 1. PERFORMANCE EVALUATION

              1. 1.1. Performance evaluation plan

              2. 1.2. Demonstration of the scientific validity and the analytical and clinical...

                 1. 1.2.1. Demonstration of the scientific validity

                 2. 1.2.2. Demonstration of the analytical performance

                 3. 1.2.3. Demonstration of the clinical performance

              3. 1.3. Clinical evidence and performance evaluation report

                 1. 1.3.1. The manufacturer shall assess all relevant scientific validity, analytical and...

                 2. 1.3.2. Performance evaluation report

                 3. 1.3.3. The clinical evidence and its assessment in the performance evaluation...

           2. 2. CLINICAL PERFORMANCE STUDIES

              1. 2.1. Purpose of clinical performance studies

              2. 2.2. Ethical considerations for clinical performance studies

              3. 2.3. Methods for clinical performance studies

                 1. 2.3.1. Clinical performance study design type

                 2. 2.3.2. Clinical performance study plan

                 3. 2.3.3. Clinical performance study report

           3. 3. OTHER PERFORMANCE STUDIES

        2. PART B POST-MARKET PERFORMANCE FOLLOW-UP

           1. 4. PMPF shall be understood to be a continuous process that...

           2. 5. PMPF shall be performed pursuant to a documented method laid...

              1. 5.1. The PMPF plan shall specify the methods and procedures for...

              2. 5.2. The PMPF plan shall include at least:

           3. 6. The manufacturer shall analyse the findings of the PMPF and...

           4. 7. The conclusions of the PMPF evaluation report shall be taken...

           5. 8. If PMPF is not deemed appropriate for a specific device...

    15. ANNEX XIV

        INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES

        1. CHAPTER I DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES

        2. CHAPTER II OTHER OBLIGATIONS OF THE SPONSOR

    16. ANNEX XV

        CORRELATION TABLE