The New EU MDR Transition Period Extended Due to COVID-19
In May or 2017, the European Parliament published the EU MDR - the European Union's Medical Device Regulation - which aimed to extended and improve upon the aging MDD (Medical Device Directive). While many of the principles remain the same between the MDD and the MDR, the MDD policies were initially written almost 30 years ago, and the Parliament felt it was time to bring the regulations up to current standards.
The most notable changes in the MDR include a expansion of the products covered by the regulations, as well as the novel concept of formally assigning responsibility to at least one person in each organization to ensure regulatory compliance.
While the previous directive covered a wide range of medical devices, the new MDR significantly expands the included products - for example, non-medical devices which are similar to devices with a medical purpose (such as colored, cosmetic, non-corrective contact lenses).
Additionally, every organization that participates in the medical device supply chain (now extended to include not only manufacturers, but distributors and importers as well) must have at least one representative deemed ultimately responsible for the compliance of their products. Typically, this role is filled by a Quality Compliance Manager or similar.
Furthermore, the new MDR includes additional expansions of regulations, such as the extension of UDI requirements to Europe. Already an established standard in the United States, a unique device identifier (UDI) is a distinct identification number that accompanies each device to more specifically track and trace medical devices. There are some differences between UDI requirements in the US, and the UDI requirements outlined by the EU MDR -- check out this post which details these differences.
While this new legislation was initially released in 2017, the European Parliament gave manufacturers a 3-year transition period to begin implementing these changes. Set to go into enforcement on May 26, 2020, the COVID-19 pandemic has altered those plans. In April, the European Parliament pushed the enforcement date by one year -- now planned to go into effect on on May 26, 2021.
Many medical device companies, both in Europe and worldwide, welcome this extension as reports dating back as far as September 2019 show that many manufacturers were struggling to comply with the new regulations, with some reports stating only a fourth of organizations would be ready to comply by May 2020. It should be noted that medical device companies can, under certain circumstances, extend the transition period until as late as May 2025.
For additional information on the EU MDR, you can visit https://ec.europa.eu/growth/sectors/medical-devices_en.