EU postpones Medical Device Regulation (MDR)
In April, the European Commission decided to postpone the entry into force of the Medical Device Regulation (MDR) by a year – initially until 26 May 2021. This decision serves the fight against the COVID-19 pandemic and is aimed at improving the availability of essential medical products in the EU.
The MDR’s goal is to assure the protection of consumers and patients. The regulation applies for all economic players and healthcare facilities throughout Europe and contains numerous obligations for all players manufacturing medical products, modifying them, making them available on the market, or using them in their business. In this way, many regulations already in existence are being further tightened or fine-tuned.
All requirements relating to the supply of aids in focus
This concerns not only manufacturers but also service providers such as medical supply stores. A present, it is still unclear whether or not transitional periods relating to the existing certification of products will be extended.
The so-called “designated bodies” are the mainstay of the new rigorous tests – only this select few are still permitted to perform certification in “on-site audits”: in view of the current safety measures and the applicable travel restrictions, it is not yet clear if and to what extent the designated bodies can issue the required certificates on time. In order to maintain the supply of medical products in Europe, professional and industry associations are therefore calling for the deferral of the transition periods and an extension of the periods for liquidation of current stocks.
Documentation, hygiene, results monitoring: strict requirements for all
The industry must continue to make preparations nonetheless: specialist retailers/medical product suppliers must fulfil comprehensive traceability and control obligations and cooperate more closely with manufacturers and preliminary suppliers. They must ensure, more than ever, that the manufacturers’ prescribed product-specific storage and transport conditions are adhered to.
The requirements for controls and storage have far-reaching effects on product management because, as is becoming clear during the COVID-19 pandemic, every supplier must always have an accurate overview of existing goods and their condition.
This creates the obligation to provide comprehensive documentation: detailed provisions on hygiene and preparation of the aids must be observed. Dealers, too, must gather, document, evaluate, and relay complaints from users and patients.
The German society for interprofessional aid supplies (DGIHV – Deutsche Gesellschaft für Interprofessionelle Hilfsmittelversorgung e.V.) has reworked all of the key rights and obligations arising for manufacturers and service providers from the EU-MDR into clearly-structured guidelines: www.dgihv.org/mdr/