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 requirements in the Regulations.
The uncertainties surrounding Brexit only add to the general unease. A significant proportion of medical devices are certified by UK notified bodies, and the EU Commission has stated that such devices may not be placed on the EU market unless compliance with EU importation requirements is demonstrated. Whether a deal on the use of UK certified devices in Europe post the UK's exit from the EU can be agreed remains to be seen. In the meantime, several UK notified bodies, including Lloyds's Register Quality Assurance, have announced plans to pull back from the medtech sector, citing operational costs to meet the new requirements and a potential no-deal Brexit.
There have been calls (including by the Irish MedTech Association and MedTech Europe) for the transitional period under the MDR and the IVDR to be extended, primarily around concerns that products may not be able to be placed on the market. However, the EU Commission has stated that the current deadline is "realistic and achievable" and an extension is unlikely.
As the second largest exporter of medtech products in Europe, Irish companies are working to comply with the impending Regulations. It is clearly important that companies work with the Notified Bodies to ensure their certifications are renewed and that all necessary re-certifications are complete ahead of May 2020.
This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.