What are the key changes in the new Medical Devices Regulation?
On May 26, 2021, the new Medical Devices Regulation, commonly abbreviated as MDR, will enter into force in Europe. It replaces the previous MDD (Medical Device Directive), which has been in the field since 1993 with the aim of harmonizing medical device laws in Europe. The MDR brings a significant amount of regulatory changes, with a major impact not only on manufacturers, but also on all stakeholders involved in the device lifecycle.
The new regulation is about four times more extensive than the previous one, in terms of documents and annexes, and the word “safety” appears 290 times compared to 40 in the MDD. All accidents, injuries, and eventual deaths related to the use of a specific device will be entered in a European portal with the task of centralizing and making transparent the information on medical devices. The new rules will require manufacturers to generate clinical data about the safety and performance of their devices, especially in relation to equivalence standards. Individual product traceability will be one of the critical aspects through the implementation of Unique Device Identification (UDI), required on all product labels.
The definition of “medical device” will also be expanded to include all devices previously defined as non-medical or aesthetic that were previously unregulated, e.g., products for disinfection, contact lenses, lasers for hair removal. Non-CE marked products will have to comply immediately with the general safety and performance requirements of MDR, while all devices already CE cleared will have to comply within four years.
The new MDR regulation was supposed to be effective from May 26, 2020, but due to the Covid-19 pandemic and the resulting international economic crisis, it was postponed one year to relieve national health authorities, notified bodies, and medical device manufacturers. A MedTech Summit survey conducted in March 2020 that interviewed companies showed that: 17% of manufacturers consider themselves fully ready to comply with the MDR, 15% say they are “not ready at all,” and 65% say they would have fully exploited the remaining time of the old MDD to be prepared.
The new regulation is an opportunity to improve – versus the past – the transparency of technical information on medical devices, thus ameliorating the quality of processes and products.