By now you may have heard the latest regarding the Medical Device Regulation (MDR) being delayed by 1 year. Great! The impossible is now a reality! Although there are still a few more administrative hurdles to jump through, there has been an overwhelming vote in Parliament in favour of the Commission’s proposal to amend the MDR, making it basically, politically a done deal! But, don’t relax your efforts now. One year goes by quickly and notified bodies will not accept any excuses after the 26th of May 2021.
A few weeks ago, we wrote an article (http://www.rni-conseil.com/en/could-medical-device-regulation-be-delayed-due-to-covid-19/) outlining the effects such a delay may have on manufacturers. In this article we stated a “business as usual” approach, working towards the original date of application. This way of thinking is of critical important to ensure no one lags behind. Use the extra breathing room to refine processes and plan for pre-clinical or clinical data generation.
The delay does however reveal an opportunity. What we have now is an additional 1 year in which the Medical Device Directive (MDD) will be applicable. And an additional 1 year for which the MDR is not applicable yet. The date of current MDD certificates will still remain valid up until the 27th of May 2024. The obvious thought here is whether or not Notified Bodies will accept new conformity procedures under the MDD for the next 1 year. Many manufacturers have neglected their low priority medical devices in an effort to focus resources on MDR certification for higher demand products. Could this news present an opportunity to re-ignite a legacy device by issuing a certificate under the current MDD? At this stage, the answer is unknown, but we anticipate it being unlikely with the already limited MDR accredited Notified Bodies and the sudden change in regulation. It is improbable that Notified Bodies will have the capacity to issue MDD conformity assessments at this stage as their resources are probably pooled with handling the MDR transition. However, the 1 year does pose the scenario of getting these legacy devices certified under the new MDR together with existing projects or under the MDD from Notified Bodies who are not pursuing MDR certification. Also, whilst the additional year gives authorities and economic operators 1 more year to prepare, it does not create more capacity.
Also, 1 additional note about this delay – Article 59 will be partially amended and come into effect on the date of entry into force of the postponement regulations. This article is very important as it makes it possible for the commission to issue authority for a particular device or groups of devices for the whole of the EU in exceptional circumstances such as the Covid-19 crisis we are currently experiencing. This amendment is aimed to address potential Covid-19 related shortages.
Separately, and unrelated to Covid-19, the Commission announced in October 2019 the postponement of the launch of EUDAMED to May 2022. EUDAMED, which has been plagued with delays after delays, enters an interesting phase with the MDR amendment. The amendment moves EUDAMED dates in a way that will actually make it possible to be phased in as was originally intended, but one year later. This raises the question about whether the Commission actually intends to depart from its plan to launch EUDAMED at the application date of May 2022 or bring it back in line to launch at the start of MDR application. We have written an article about EUDAMED and the delays here (http://www.rni-conseil.com/en/medical-devices-eudamed-and-udis-explained/).
Brexit… The UK will likely adopt the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 as a domestic Regulation, with necessary amendments from the EU MDR. The UK MDR is due to take effect from December 31st 2020 which means devices in the UK will not be subject to the EU MDR in a legal sense. This is somewhat ironic as the UK MDR was considered less strict than the EU MDR. This does mean there will be a 6 month period where the opposite is true.
RNI has been preparing for this news and is working with clients to manage this transition. Please get in touch to discuss how best to strategically plan for the next 12 months.