LONDON – The European Parliament gave its full backing to the emergency measure to delay the Medical Devices Regulation (MDR), voting by 693 to 1 in favor of postponing implementation from May 26 this year, to May 26, 2021.
The delay will “allow health authorities and manufacturers alike to prioritize the fight against the coronavirus pandemic” by keeping existing procedures in place, the parliament said in a statement.
However, there is no similar respite for manufacturers of in vitro diagnostics who are currently on the front line of the response to the pandemic, both increasing supplies and developing new COVID-19 tests. These companies must still be in compliance with the In Vitro Devices Directive (IVDR) by the existing deadline of May 26, 2022.
The race is now on to extend the validity of the current directive and to get the change to the MDR implementation date on the statute. This must be before May 26, otherwise the de facto deadline comes into effect.
One-year extension ‘a reasonable measure’
The amendment has to be referred to the European Economic and Social Committee, a citizens’ advisory group. As Parliament met in virtual session for the vote on April 17, the committee short-circuited the usual process and published a position paper throwing its support behind the proposal.
The extension of one year, is a “reasonable measure aiming at guaranteeing the smooth functioning of the internal market, a high level of protection of public health and patient safety, legal certainty and to avoid potential market disruption,” said Renate Heinisch, the committee’s secretary.
In more normal times the amendment also would have to be referred to the national parliaments of the 27 member states, a process taking eight weeks, but this step has been scrapped altogether.
The European Commission proposed the delay on March 23, saying the “extraordinary circumstances” of the pandemic have had a significant impact on various areas covered by MDR, including the designation and work of the notified bodies that conduct assessments of medical devices.
At the same time, member states and regulators have too much on their plates to police the implementation, the Commission said.
NB shortage was already problematic
In truth, it was already looking unlikely all companies could be fully prepared for the May 26 implementation of MDR, because the regulatory infrastructure is full of holes. Most crucially, only 12 notified bodies (NBs) have been certified to assess compliance with the new regulation, and they were overwhelmed and unable to take on new clients, even before lockdown meant they could not travel to audit manufacturing facilities.
The European Association of Medical Devices Notified Bodies warned in mid-March that the travel restrictions were having an impact on the implementation of both MDR and IVDR. The restrictions also are affecting audits to assess conformity with the current requirements that are now to stay in place for an extra year, the association said.
“The elephant in the room here, obviously, is how the Commission and member states failed to ensure proper implementation, said Erik Vollebregt, a life sciences and IP lawyer at Axon Lawyers in Amsterdam, who has been following the progress of MDR and IVDR for the past nine years.
Vollebregt says MDR issues ‘will not be fixed’ this year
Essential guidance, common specifications, and implementing acts have been late and almost none of the member states have their implementation legislation ready, Vollebregt said in his latest blog post. “It shows that the authorities both at EU and national level have structurally underestimated and under resourced the MDR and IVDR implementation,” he said.
“This will not be fixed in the year,” Vollebregt said, “because the root cause has not changed.”
Moving the date of implementation creates time, but it does not create extra capacity. It may be that the number of notified bodies designated to approve devices under MDR increases, but Vollebregt does not think this will change the situation.
“A notified body needs time – about six months – to get to full operating capacity, and a conformity assessment procedure mostly takes eight months at least, so any notified body designated in this extra year will not make a difference,” he said.
In addition, manufacturers who have used the soft transition period, under which certificates granted under the current rules can be extended for four years, will now have one year less to become MDR compliant.
In the face of the COVID-19 crisis, the European Parliament on Friday also approved €3 billion (US$3.3 billion) of EU funding to support health care. The money is for urgent medical supplies, including masks and respiratory equipment. Looking beyond the crisis, MEPs called for a massive recovery package and the setting up of a €50 billion EU coronavirus solidarity fund.
Parliament also wants to increase European production of medical devices and drugs, to be better prepared for such a crisis in future. That would be backed by a European Health Response Mechanism, with stockpiling of medical equipment that could be quickly mobilized.