Medical Devices Regulations (MDR and IVDR)
Today, May 26 2020, the Medical Devices Regulation (MDR) would enter into force. However, the European Commission announced on the 3rd of April 2020 that the introduction will be postponed by one year due to the Corona-pandemic.
The introduction of the In-vitro Diagnostic Regulation (IVDR) is only scheduled to take effect on 26 May 2022. Don't wait too long to prepare for the upcoming changes, but start this in advance if you haven't already done so.
The MDR will apply to all medical devices except those covered by the IVDR. A new group of non-medical devices is also included in the scope (products without an intended medical purpose). This includes, for example, contact lenses, cosmetic implants and fillers, but also accessories such as products for cleaning and sterilization of devices. Medicines, blood(products), cosmetics and food are excluded from the scope of the MDR.
The new regulations bring a number of important changes compared to the previously applicable directives for manufacturers, distributors, importers, healthcare institutions and other economic actors within the medical devices industry. Spearheads of the new regulations are: stricter ex-ante control for high-risk devices, a new risk classification system, more transparency and better traceability of medical devices, introduction of an implant card, introduction of the UDI and Eudamed database, appointment of a person responsible for regulatory compliance (PRRC) who is, incidentally, jointly and severally liable for products, and reinforcement of post-market surveillance.
Are you a manufacturer, distributor, importer or authorized representative and would you like to know what (additional) obligations will apply to you under the new regulations? Or are you a healthcare institution and would you like to know more about the in-house manufacture of medical devices under the MDR? Please do not hesitate to contact us. We would be happy to assist you.