LONDON – The European Commission (EU) is pulling the plug on implementation of the Medical Devices Directive (MDR) on May 26, to free up resources and expertise as countries across Europe struggle to deal with the COVID-19 crisis.
The European Commission is drawing up a proposal to postpone the regulation for one year. “This will relieve pressure from national authorities and industry, and it will allow them to focus fully on urgent priorities related to the coronavirus,” said commission spokesman Stefan de Keersmaeker, announcing the delay.
The proposal, which should be ready in early April, will need the approval of heads of state in the European Council and of the European Parliament. “We call on parliament and the council to adopt it quickly,” de Keersmaeker said.
The move followed an urgent call by the industry body MedTech Europe, which said members working flat out to provide personal protective equipment, diagnostics, ventilators and other critical equipment are facing severe disruptions to preparations for MDR.
At the same time as ramping up production of COVID-19 necessities, companies have been dealing with the effects of the pandemic on their own organizations, with staff sick, self-quarantined or forced to work from home, and international and domestic travel bans in place. There have been disruptions of supply and distribution chains.
While encouraging members to continue with MDR preparations where possible, MedTech Europe said it is happy with the move to delay. “We welcome this announcement of the European Commission’s to propose postponement of the date of application of MDR by 12 months,” a spokesperson told BioWorld.
The EU’s announcement made no mention of the In vitro Diagnostic Regulation, currently scheduled to take effect on May 26, 2022, but MedTech Europe wants to see “a similar solution,” the spokesperson said.
Although there is a longer time to implementation, diagnostic manufacturers and regulatory authorities alike must prepare for major changes. “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,” said the spokesperson.
“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 and running effectively in times of the COVID-19 pandemic,” he said.
COVID-19 aside, it already was looking unfeasible for all companies to be fully prepared for the May 26 implementation of MDR, because the regulatory infrastructure is full of holes. Most crucially, only 12 notified bodies have been certified to assess compliance with the new regulation. That has left companies finding it hard to meet the requirements, and not through any fault of their own.
The industry was struggling to meet the deadline for implementing the MDR on time, in particular because of the shortage of certified notified bodies, but also because of dealing with the U.K. leaving the EU regulatory system after Brexit, said Maria Manley, partner at the London law firm, Sidley Austin LLP. “It is therefore unsurprising that the commission is working on a proposal to postpone the implementation of the MDR by one year,” Manley said.
Since COVID-19 took hold, the attention of the industry has switched to dealing with the epidemic said Cliodhna McDonough, director and regulatory lawyer at the London-based law firm Fieldfisher. “I’m dealing on a daily basis with compliance queries to do with COVID-19,” she told BioWorld.
The limited number of notified bodies that are certified to do so, continue to process MDR assessments. But it has become impossible for them to do their job properly. “The difficulty is, in the absence of being able to travel and have a detailed look at sites, they can’t complete assessments,” McDonough said.
The shortcomings in the notified body system are exacerbated because regulatory authorities are preoccupied with the virus. “They are now focusing on COVID-19, so there’s no bandwidth,” said McDonough.
Across Europe, there have been 265,421 confirmed cases of COVID-19 and nearly 16,000 people have died.
The huge surge in the number of patients hospitalized with the coronavirus infection has seen sections of the economy in some countries put on a war footing, with manufacturers of cars, aircraft engines and domestic appliances, asked to turn their hands to making ventilators and personal protective equipment.
There are reports of scuba diving equipment being repurposed, and of 3D printing of valves for respirators.
That is further increasing the load on regulators, which are trying to fast track approvals. “Our challenge is to make sure supplies can get through, but at the same time make sure they are safe,” McDonough said.
To ease the load, the European Commission has recommended to national regulators that they allow non-certified personal protective equipment on the market “for a limited period of time” in advance of products completing conformity assessments.
In the U.K., the Medicines and Regulatory products Agency said it would authorize the supply of non-CE marked devices if it is, “in the interest of the protection of health.”
A further distraction for national regulators is a rise in the number of illegal products related to COVID-19. Between March 3-10, Operation Pangea, the annual global operation between police, customs officers and regulators in 90 countries to tackle fraud in medicines and medical devices, found more than 34,000 unlicensed and fake products claiming to be effective against the coronavirus.
In terms of what companies should do in response to the European Commission saying it wants a 12-month delay to MDR implementation, Erik Vollebregt, medical devices expert at the legal firm Axon Lawyers in Amsterdam, advised companies not to treat the proposal as a done deal. “That would be a bad idea,” he said.
While the Commission’s statement says the decision is intended to relieve pressure and allow companies to focus on COVID-19, “it is not saying you should just drop all MDR prep work,” Vollebregt said. “The MDR is still coming and you don’t know what this amendment – if it is amended – will look like.”