EU-MDR 2017/745 — Overview of changes
Please note: This overview is not intended to be an exhaustive list, nor is it meant to replace a consultation from certification experts.
- New classification rules, which in some cases means a change in the class of devices and potentially a higher classification (e.g. devices with nanomaterials, devices composed of substances) (Annex VIII of the regulation)
- Recertification may become necessary due to the changes in the class of devices, in particular on account of the new class Ir “reusable surgical instruments” (Annex VIII)
- Class I medical devices for which the declaration of conformity was drawn up prior to 26 May 2020 according to previously valid law may continue to be placed on the market without the involvement of a notified body until 26 May 2024 (EU-MDR Corrigendum II from 25 November 2019)
- Requirements for technical documentation are regulated in greater detail (Annex II)
- New definitions, which differ in part from the previous Medical Devices Directive 93/42/EEC (MDD) and the German Medical Devices Act (MPG) (Article 2, “Definitions”)
- Manufacturers, authorised representatives, importers, distributors and the person referred to in Article 22(1) and 22(3) are now all considered to be “economic operators” (Article 2 Number 35)
- The person referred to as the “safety officer” in Section 30 of the German Medical Devices Act is called the “person responsible for regulatory compliance” in the EU-MDR and must provide evidence of a higher level of qualification and experience (Article 15)
- A change in the notified body may become necessary, as the requirements for notified bodies have been amended (Article 36)
- Extension of the power competent authorities have with regard to the clinical post-market surveillance of medical devices, including unannounced audits (Article 93)
- Medical devices must satisfy extended general safety and performance requirements (Annex I)
- Each medical device must be assigned a Unique Device Identifier (UDI) for identifying the registered product more easily and quickly (Article 2 Number 15)
- More stringent requirements with regard to linguistic clarity: “Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date.” (Article 16(3))
- The instructions for use are to be written “in terms readily understood by the intended user” (Annex I Number 23.1)
- Content intended for patients and users regarding medical devices on the market in the EU must be composed in the languages of all the Member States in which the products are envisaged to be sold (Annex II Number 2)
- The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available (Article 19(1))
- Translations must typically already be prepared prior to the submission of technical documentation to the notified bodies.
Primary source: EU Regulation 2017/745, available here as a PDF:
https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32017R0745
Other sources (all accessed 28 January 2020):
https://alps-gmbh.de/neues-von-der-iso-13485-die-umstellung-von-mdd-zu-mdr-ist-in-vollem-zuge/
https://www.spectaris.de/medizintechnik/themen/ueberblick-zur-neuen-eu-medizinprodukteverordnung/
