GLOSSARYEU
EU MDR
Regulation (EU) 2017/745, the European Union regulation on medical devices for human use. The regulation governs placing devices on the market, making them available, and putting them into service. EU MDR repealed Council Directives 90/385/EEC and 93/42/EEC.
Avoid This Mistake
MDR also abbreviates medical device reporting under 21 CFR Part 803 in the United States, so a bare MDR can mean either.
Annexes
- MDR Annex I (GSPR)The EU MDR's list of general safety and performance requirements for devices. It runs in three chapters: general requirements, requirements for design and manufacture, and requirements for the information supplied with the device.
- MDR Annex II (Technical Documentation)The content a manufacturer's technical documentation must include. The documentation has to be clear, organized, readily searchable, and unambiguous. It runs in six sections, from the device description to verification and validation.
- MDR Annex III (Post-Market Surveillance Documentation)The content of the technical documentation on post-market surveillance, drawn up under Article 83 through Article 86. It starts with the post-market surveillance plan required by Article 84.
- MDR Annex IV (Declaration of Conformity)The information an EU declaration of conformity must contain. It includes the manufacturer's name and address, a statement that the manufacturer alone is responsible for issuing the declaration, and the Basic UDI-DI.
- MDR Annex V (CE Marking)The form of the CE marking: the initials CE in a set graduated shape. The parts must have substantially the same vertical dimension, which may not be less than 5 mm. The minimum may be waived for small-scale devices.
- MDR Annex VI (Registration and UDI)Registration information for devices and economic operators, the core data elements given to the UDI database with the UDI-DI, and the UDI system itself.
- MDR Annex VII (Notified Body Requirements)The requirements a notified body must meet. They fall into four groups: organizational and general requirements, quality management requirements, resource requirements, and process requirements.
- MDR Annex VIII (Classification Rules)The rules that sort devices into class I, IIa, IIb, or III. Chapter I defines terms such as duration of use, Chapter II covers applying the rules, and Chapter III sets out 22 classification rules.
- MDR Annex IX (QMS and Technical Documentation Assessment)Conformity assessment based on a quality management system and on assessment of technical documentation. Chapter I covers the quality management system, Chapter II the assessment of technical documentation, and Chapter III administrative provisions.
- MDR Annex X (Type-Examination)Conformity assessment in which a notified body ascertains and certifies that a device fulfils the relevant provisions of the Regulation. The body examines the technical documentation, the relevant life cycle processes, and a representative sample of the planned production.
- MDR Annex XI (Product Conformity Verification)Conformity assessment that ensures devices conform to the type certified under Annex X and meet the Regulation's provisions that apply to them. Part A covers production quality assurance and Part B covers product verification.
- MDR Annex XII (Notified Body Certificates)Certificates a notified body issues: among the general requirements, a certificate must be in an official language of the Union, refer to only one conformity assessment procedure, and be issued to only one manufacturer.
- MDR Annex XIII (Custom-Made Devices)The procedure for custom-made devices. The manufacturer or its authorized representative draws up a statement. The statement gives the manufacturer's details, data identifying the device, and a declaration that the device is for the exclusive use of a particular patient or user.
- MDR Annex XIV (Clinical Evaluation and PMCF)Clinical evaluation in Part A and post-market clinical follow-up in Part B.
- MDR Annex XV (Clinical Investigations)Clinical investigation requirements. Chapter I sets general requirements, Chapter II covers the documentation for the application for a clinical investigation, and Chapter III covers the sponsor's other obligations.
- MDR Annex XVI (Products Without a Medical Purpose)The list of groups of products without an intended medical purpose that Article 1(2) brings under the Regulation. Examples include contact lenses and items introduced into or onto the eye.