(06/2021) Caroline Meyer, Head of Operations, ceyoo gmbh
Regulation EU 2017/745 of the European Parliament and of the Council of April 5, 2017 on medical devices (MDR) has been in force since May 26, 2021. With the MDR, many new and changed regulations have come into force, manufacturers and other economic actors in the supply chain (importers,
Dealers and authorized agents) must now comply.
Manufacturers who already came under the scope of the Medical Device Directive (MDD, 93/42 / EEC) or the previous Directive on active implants (AIMDD, 90/385 / EEC) with their products also fall under the scope of the MDR. The MDR also defines a new group of class I products (Im, Is, Ir), for which a notified body must now be involved in the conformity assessment process. Manufacturers should also pay particular attention to the products in their portfolio that have no medical purpose but are nonetheless regulated by the MDR (MDR, Annex XVI). The scope of application of the MDR has expanded here compared to the MDD.
Status quo of the MDR implementation
If you followed the transitional provisions in Article 120, you were probably able to obtain an EC certificate with the longest possible period of validity, up to 26 May 2024 at the latest, in order to theoretically be able to place your products on the market until the certificate expires . However, this only applies to products on which no significant changes to the design or the intended use are made after the EC certificate has been issued. But which requirements of the MDR do you as a manufacturer have to meet from the deadline? Post-market surveillance (Art. 83-86), vigilance (Art. 87-92) and the registration of economic actors (Art. 31) - including the PRRC / Person Responsible for Regulatory Affairs (Art. 15) - and of products (Art. 29). For your QM system, these requirements mean the integration of a suitable PMS (Post-Market Surveillance) process and the anchoring of the PRRC, the person responsible for compliance with the regulatory provisions, as a role in the company. By means of this PMS process, you are able and, from the beginning of the validity, also obliged to carry out proactive and reactive market observation. Any product placed on the market after the deadline must be covered by a PMS plan.
MDR-ready: What counts for you now
You have already met the basic requirements from the start of validity; now you are striving for product certification of your medical devices under the MDR. In contrast to the MDD, under the MDR the technical documentation is now checked prior to the audit. And in order to pass this file review, the technical documentation must not only be created in accordance with Annex II and III, but must also be presented “in a clear, organized, easily searchable and unambiguous form”. If you've been active beyond these requirements and have worked out a plan to transition your entire product portfolio, you are well prepared. The changeover to the MDR offers the rare opportunity to make fundamental strategic decisions in relation to the QM system and all matters relating to the technical documentation of your products and the product portfolio yourself. You can make good use of the transition period until your MDD certificate expires and, by means of the investment required to achieve MDR conformity, link the implementation plan with your corporate strategy. If this plan presents you with a challenge due to the size and complexity of your product portfolio or a lack of resources, use the following guide to assist you:
Above all, focus on evaluating your medical devices. First check the risk class according to the MDR rules (Appendix VIII) as well as the intended purpose and, if necessary, reorganize your product groups together with your clinical affairs experts in order to reduce the sampling, the effort of the clinical evaluation and the P
