The Medical Device Regulation ("MDR") and the In Vitro Diagnostic Regulation ("IVDR") ("Regulations") are due to take effect on 26 May 2020 and 26 May 2022 respectively.
The Regulations represent a significant overhaul of the existing regulatory system for medical devices in Europe. With less than a year to go until the MDR comes into effect, we take a look at how prepared the industry is for the changes from a legal and regulatory perspective.
The Regulations provide for three and five year transitional periods for a staggered application of the new requirements. During this transitional period, devices can continue to be certified and placed on the market under the current Directives.
Industry is becoming increasingly concerned that numerous elements of the new system are yet to be developed, creating uncertainty, particularly surrounding the ability to ensure continuity of care to patients.
The Regulations set out the greater role that Notified Bodies will have to play in enforcement - including the right to carry out unannounced on-site audits and to conduct physical or laboratory tests on medical devices as part of their compliance activities. Despite the impending deadline of May 2020, of the 42 Notified Bodies who have so far applied for designation under the MDR, only four have received designation, (as compared to the 58 currently designated). In Ireland, the Health Products Regulatory Authority ("HPRA") has stated that designation can take up to 18 months. In the UK, BSI Group (the first Notified Body to be designated) lamented that the process took 26 months.
Although HPRA have stated they anticipate the first MDR designated Notified Bodies will begin assessing and certifying devices to the MDR by mid-2019, there is a concern that re-designation of current Notified Bodies will not happen in time, and whether the Notified Bodies will have the necessary additional resources and capacity to address the new...