Article 38.Application by conformity assessment bodies for designation
Article 40.Nomination of experts for joint assessment of applications for notification
Article 43.Identification number and list of notified bodies
Article 45.Review of notified body assessment of technical documentation and clinical evaluation documentation
Article 48.Peer review and exchange of experience between authorities responsible for notified bodies
CHAPTER V CLASSIFICATION AND CONFORMITY ASSESSMENT
SECTION 2 Conformity assessment
Article 53.Involvement of notified bodies in conformity assessment procedures
Article 54.Clinical evaluation consultation procedure for certain class III and class IIb devices
Article 55.Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
Article 57.Electronic system on notified bodies and on certificates of conformity
Article 59.Derogation from the conformity assessment procedures
CHAPTER VI CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS
Article 62.General requirements regarding clinical investigations conducted to demonstrate conformity of devices
Article 64.Clinical investigations on incapacitated subjects
Article 66.Clinical investigations on pregnant or breastfeeding women
Article 74.Clinical investigations regarding devices bearing the CE marking
Article 75.Substantial modifications to clinical investigations
Article 76.Corrective measures to be taken by Member States and information exchange between Member States
Article 77.Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination
Article 78.Coordinated assessment procedure for clinical investigations
Article 80.Recording and reporting of adverse events that occur during clinical investigations
Article 82.Requirements regarding other clinical investigations
CHAPTER VII POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
CHAPTER IX CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
CHAPTER I GENERAL REQUIREMENTS
1. Devices shall achieve the performance intended by their manufacturer and...
2. The requirement in this Annex to reduce risks as far as...
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 side-effects, shall...
9. For the devices referred to in Annex XVI, the general safety...
CHAPTER II REQUIREMENTS REGARDING DESIGN AND MANUFACTURE
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...
10.5. Devices shall be designed and manufactured in such a way...
10.6. 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. Where necessary devices shall be designed to facilitate their safe...
11.3. Devices labelled as having a specific microbial state shall be...
11.4. Devices delivered in a sterile state shall be designed, manufactured...
11.5. Devices labelled as sterile shall be processed, manufactured, packaged and,...
11.6. Devices intended to be sterilised shall be manufactured and packaged...
11.7. Packaging systems for non-sterile devices shall maintain the integrity and...
11.8. The labelling of the device shall distinguish between identical or...
12. Devices incorporating a substance considered to be a medicinal product...
14. Construction of devices and interaction with their environment
14.1. If the device is intended for use in combination with...
14.2. Devices shall be designed and manufactured in such a way...
14.3. Devices shall be designed and manufactured in such a way...
14.4. Devices shall be designed and manufactured in such a way...
14.5. Devices that are intended to be operated together with other...
14.6 Any measurement, monitoring or display scale shall be designed and...
14.7. Devices shall be designed and manufactured in such a way...
17. Electronic programmable systems — devices that incorporate electronic programmable systems...
17.1. Devices that incorporate electronic programmable systems, including software, or software...
17.2. For devices that incorporate software or for software that are...
17.3. Software referred to in this Section that is intended to be...
17.4. Manufacturers shall set out minimum requirements concerning hardware, IT networks...
18. Active devices and devices connected to them
18.1. For non-implantable active devices, in the event of a single...
18.2. Devices where the safety of the patient depends on an...
18.3. Devices where the safety of the patient depends on an...
18.4. Devices intended to monitor one or more clinical parameters of...
18.5. Devices shall be designed and manufactured in such a way...
18.6. Devices shall be designed and manufactured in such a way...
18.7. Devices shall be designed and manufactured in such a way...
18.8. Devices shall be designed and manufactured in such a way...
19. Particular requirements for active implantable devices
19.1. Active implantable devices shall be designed and manufactured in such...
19.2. Active implantable devices shall be designed and manufactured in such...
19.3. Active implantable devices and, if appropriate, their component parts shall...
19.4. Active implantable devices shall bear a code by which they...
20. Protection against mechanical and thermal risks
20.1. Devices shall be designed and manufactured in such a way...
20.2. Devices shall be designed and manufactured in such a way...
20.3. Devices shall be designed and manufactured in such a way...
20.4. Terminals and connectors to the electricity, gas or hydraulic and...
20.5. Errors likely to be made when fitting or refitting certain...
20.6. Accessible parts of devices (excluding the parts or areas intended...
21. Protection against the risks posed to the patient or user...
22. Protection against the risks posed by medical devices intended by...
CHAPTER III REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE
3.2. Shipping containers shall be exempted from the requirement in Section 3.1....
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...
3.10. Manufacturers that repackage and/or relabel devices, with their own label...
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...
4.7. If there are significant constraints limiting the use of both...
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...
5. General principles of the UDI database
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...
5.8. 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
6.3. Systems and procedure packs as referred to in Article 22
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...
REQUIREMENTS TO BE MET BY NOTIFIED BODIES
1. ORGANISATIONAL AND GENERAL REQUIREMENTS
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...
1.2.7. 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...
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
3.5. Monitoring of competences, training and exchange of experience
CHAPTER I DEFINITIONS SPECIFIC TO CLASSIFICATION RULES
2. INVASIVE AND ACTIVE DEVICES
2.1. ‘Body orifice’ means any natural opening in the body, as...
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...
3.1. Application of the classification rules shall be governed by the...
3.3. Software, which drives a device or influences the use of...
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 III CLASSIFICATION RULES
CHAPTER I QUALITY MANAGEMENT SYSTEM
1. The manufacturer shall establish, document and implement a quality management...
3. Surveillance assessment applicable to class IIa, class IIb and class...
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...
3.6. The notified body shall ensure that the composition of the...
3.7. If the notified body finds a divergence between the sample...
CHAPTER II ASSESSMENT 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 examine the application by 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...
6. Batch verification in the case of devices incorporating, as an...
CONFORMITY 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...
PART A PRODUCTION 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,...
8. Batch verification in the case of devices incorporating, as an...
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...
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
16. Batch verification in the case of devices incorporating, as an...
CERTIFICATES ISSUED BY A NOTIFIED BODY
CHAPTER I GENERAL REQUIREMENTS
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...
PROCEDURE 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...
CHAPTER I GENERAL REQUIREMENTS
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 II DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION
3. Clinical Investigation Plan
3.1.1. Single identification number of the clinical investigation, as referred to...
3.1.2. Identification of the sponsor — name, address and contact details...
3.1.3. Information on the principal investigator at each investigational site, the...
3.1.4. A brief description of how the clinical investigation is financed...
3.1.5. Overall synopsis of the clinical investigation, in an official Union...
3.2. Identification and description of the device, including its intended purpose,...
3.3. Risks and clinical benefits of the device to be examined,...
3.4. Description of the relevance of the clinical investigation in the...
3.5. Objectives and hypotheses of the clinical investigation.
3.6. Design of the clinical investigation with evidence of its scientific...
3.6.1. General information such as type of investigation with rationale for...
3.6.2. Information on the investigational device, on any comparator and on...
3.6.4. Details of measures to be taken to minimise bias, such...
3.6.5. Description of the clinical procedures and diagnostic methods relating to...
3.7. Statistical considerations, with justification, including a power calculation for the...
3.10. Policy regarding follow-up and management of any deviations from the...
3.11. Accountability regarding the device, in particular control of access to...
3.12. Statement of compliance with the recognised ethical principles for medical...
3.14. Safety reporting, including definitions of adverse events and serious adverse...
3.15. Criteria and procedures for follow-up of subjects following the end,...
3.16. A description of the arrangements for taking care of the...
3.17. Policy as regards the establishment of the clinical investigation report...
3.18. List of the technical and functional features of the device,...
4.1. A signed statement by the natural or legal person responsible...
4.2. Where applicable according to national law, copy of the opinion...
4.3. Proof of insurance cover or indemnification of subjects in case...
4.4. Documents to be used to obtain informed consent, including the...
4.5. Description of the arrangements to comply with the applicable rules...
4.6. Full details of the available technical documentation, for example detailed...
CHAPTER III OTHER 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...
LIST 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...