With nearly two months before the planned start, MedTech Europe is arguing implementation of the Medical Device Regulation be delayed until six months after the COVID-19 crisis has passed.
The trade group of big medical device companies on Monday formally outlined how the industry is “working relentlessly” to get devices needed for the fight against the novel coronavirus to healthcare professionals, while simultaneously trying to maintain the supply of all other products.
MedTech Europe said executing those tasks “severely disrupts” efforts to implement MDR, leading it to push the European Union to pause implementation until after the pandemic is over.
The COVID-19 pandemic is placing particular strains on medtech companies, which are dealing with the effects of the outbreak on their organizations while trying to meet unprecedented demand for personal protective equipment, diagnostics, ventilators and other devices. That demand is coming on top of the routine need to supply patients and healthcare professionals with devices and diagnostics unrelated to the pandemic, MedTech Europe described.
In its statement, MedTech Europe said helping healthcare systems overcome the outbreak will be the top priority and focus of medtech companies “for the next few months.” That will divert attention away from what, until recently, looked set to be the biggest challenge faced by medtech in 2020.
“MedTech Europe therefore calls on the European Institutions to postpone implementation of these Regulations and resume it six months after the present crisis has passed. The crisis could be considered passed when, for instance the World Health Organization or other relevant authority (where critical preparedness activities are ongoing) declares the pandemic to be over,” the trade group wrote.
The statement is the bluntest request MedTech Europe has made for more time to implement MDR. In the past, the trade group has raised concerns about the state of MDR preparations and called for urgent changes without specifying the terms of a desired delay.
Other groups have previously called for a delay without success. Perhaps most notably, in July the U.S. urged the EU to “delay implementation by three years to allow for U.S. exporters to adapt to the new requirements.” More recently, German medtech trade group BVMed called for the EU to push MDR implementation out until after the coronavirus crisis.
To date, none of the requests have led the EU to change course. Just last week, with Italy in the midst of a full-bore coronavirus crisis and other countries on the same path, the European Commission's Medical Device Coordination Group reaffirmed its commitment to the May 26 go-live date in a plan that made no mention of the COVID-19 pandemic.
Yet, the EU has shown a willingness to budge, and even bend procedures, to allay concerns about MDR in the past. Late last year, for example, the EU created a corrigendum to MDR to give makers of Class I devices more time to comply with the regulations. The EU is supposed to use corrigenda to fix errors in adopted texts but in that instance deployed the tool to make a substantial change.
Some corrigenda are adopted without being put to the vote. However, the more substantial nature of the Class I delay corrigendum led to a request for a vote in the European Parliament.
As a still more substantial change, the delay of MDR may involve a co-decision procedure, meaning that the European Parliament and Council would need to jointly adopt legislation mandating a new implementation date. Under normal circumstances, reaching a co-decision can be a complex, lengthy process. In the absence of a timely mechanism for a formal delay, it may be possible for the EU to indicate it will apply enforcement discretion to ensure devices keep reaching patients after May 26.