Belgium, (Brussels Morning Newspaper) The European Commission has revised rules for the certification of medical devices following criticism from experts and medical associations.
The Commission stressed in a statement last week that new rules will give companies more time to certify their medical devices and lower the risk of shortages.
“The proposal introduces a longer transition period to adapt to new rules as foreseen under the Medical Devices Regulation (MDR),” the EC noted and added that the move will mitigate the risk of shortages.
“The availability of safe medical devices for European patients is our priority,” the Commission stressed and pointed out “this proposal does not change any of the current safety and performance requirements provided for in the MDR,” but extends the transition period.
Medical associations and companies warned in December last year that new rules could lead to shortages as smaller companies cannot afford to comply with MDR and could be pushed off the market.
EC responds to concerns
Margaritis Schinas, European Commissioner for Promoting our European Way of Life, pointed out that “medical devices save lives by providing innovative healthcare solutions.”
He added that new rules will “address the risk of shortages of medical devices on the EU market” brought on by rules that the EC adopted previously” and noted that “more than 500,000 types of medical devices” are present on the EU market.
Schinas concluded that the EC “will not allow any risk of significant disruption in the supply of various medical devices on the market, which would affect healthcare systems and their ability to provide care to European patients.”
Stella Kyriakides, European Commissioner for Health and Food Safety, stated “our rules on medical devices will always prioritize patient safety and support for innovation.”
She warned that healthcare systems across the EU are at risk of shortages due to “a combination of factors” and stressed “today, we propose a revised regulatory timeline to provide certainty to the industry in order to continue producing essential medical devices.”
Kyriakides stated that EC’s latest move reduces short-term risks of shortages and called on EU bodies to adopt the proposal quickly.
“Member states and notified bodies should also work with industry to ensure a transition to the new rules provided for by the MDR without further delay,” she concluded.