UPDATE: April 3, 2020: The European Commission on Friday adopted a proposal to postpone implementation of the EU Medical Device Regulation by one year until May 26, 2021.
The proposal concurrently calls for a delay to the repeal of the existing Medical Device Directive.
To take effect, the EC said the proposal "would need the full support of the European Parliament and the Council through an accelerated co-decision procedure."
"As the coronavirus crisis increases demands for certain vital medical devices, it is crucial to avoid any further difficulties or risks of potential shortages or delays in the availability of such devices caused by capacity limitations of authorities or conformity assessment bodies related to the implementation of the Medical Devices Regulation," the EC wrote in a statement Friday.
The EC specified the proposal does not change the May 26, 2022, start date for the In Vitro Diagnostic Regulation.
- The European Commission is working on a proposal to delay enforcement of the EU Medical Device Regulation by one year, a spokesperson said Wednesday.
- Policymakers are aiming to submit the proposal in early April, and are imploring the European Parliament and Council to quickly adopt the postponement ahead of the May 26 go-live date for the regulatory overhaul. "This will relieve pressure from national authorities and industry and it will allow them to focus fully on urgent priorities related to the coronavirus crisis," EC spokesperson Stefan de Keersmaecker read in a statement.
- The announcement was preceded by numerous calls to push back MDR's previously unshakeable start date in light of challenges introduced by the ongoing COVID-19 pandemic, including from trade association MedTech Europe and from Socialists and Democrats (S&D) in Parliament.
Formal reassurance for industry that MDR will not take force in two months as originally planned appears to be on the horizon.
Despite regulators hardly budging the past year as industry worried a notified body shortage would render MDR implementation in 2020 unrealistic, a one-year postponement would recognize the burden medtechs face in trying to supply healthcare workers with necessary medical technologies to fight COVID-19 and maintain business operations while countries are shut down.
The European Commission has faced increasing pressure to implement a delay as the novel coronavirus has taken hold of Europe and much of the rest of the world.
“Although the regulation contains very important elements to improve patient safety, in these unprecedented times, the priority should be on meeting the demand for medical devices and equipment," Croatian Parliament member and S&D medical devices spokesperson Biljana Borzan said in a statement Tuesday.
“This should be seen as just a temporary measure. An extraordinary measure for extraordinary times. Therefore, we demand the Commission to postpone its implementation until after the fight against Coronavirus has been won.”
In a letter Tuesday to EC President Ursula von der Leyen and Commissioner for Health and Food Safety Stella Kyriakides, the group of S&D members of Parliament said they are also open to proposals by the Commission to make changes to the current directives.
Kyriakides flagged the Commission's response on social media Wednesday.
Vital devices needed to treat #COVID19 patients must remain available on ???????? markets. For that reason, at the @EU_Commission, we are working to put forward a proposal to delay the implementation of the new medical devices Regulation by 12 months.— Stella Kyriakides (@SKyriakidesEU) March 25, 2020
MedTech Europe said Wednesday that while it welcomes the EC's plans, as well as "the support that the European Parliament has expressed for this," the trade association remains convinced "a similar solution is needed" regarding implementation of the In Vitro Diagnostic Regulation (IVDR).
The group argued that although IVDR's start date isn't until 2022, diagnostic makers' preparations that would have happened this year is being equally disrupted by coronavirus response.
"Right now, their capacity is focused on the critical task of keeping diagnostic tests available, despite the challenges the pandemic is creating for their production and distribution," MedTech Europe wrote in a statement Wednesday. "By providing the same solution for the in vitro diagnostics and medical devices sectors, the EU would be doing even more to keep health systems up running effectively in times of the COVID19 pandemic."
MedTech Europe had on Monday requested that implementation of both MDR and IVDR be paused and not resumed until six months after the crisis passes, which the group said could be defined by the World Health Organization declaring the pandemic over.
This story has been updated with a statement from MedTech Europe.