The EU’s strict approval procedure for medical devices must temporarily be relaxed during the COVID-19 outbreak in order to allow ramping up production of vital equipment such as ventilators, a German lawmaker in the European Parliament has warned.
Updated three years ago in the wake of a breast implant scandal in France, the EU regulation on medical devices now risks standing in the way of medical firms producing life-saving COVID-19 equipment, MEP Peter Liese told journalists during a teleconference call on Friday (20 March).
“Here, we have a challenge,” Liese said. Manufacturers of medical devices are much more strictly regulated today than they were before the regulation was updated in 2017, a move that was necessary at the time because of the breast implant scandal in France, Liese said.
“But right now it could be dangerous for fighting the COVID-19 pandemic,” he warned.
Some companies producing life-saving equipment such as ventilators may not be able to obtain parts because of supply problems caused by the crisis, Liese said.
And if they want to modify their production in the face of the current constraints, they are supposed to fill “hundreds of pages” of application forms and undergo a testing procedure which can take several months before getting approval from authorised notification bodies at the national level, he said.
“I have encouraged the EU health Commissioner and Ursula von der Leyen to look into it. And they are about to propose guidelines” to adapt the EU regulation on medical devices to the emergency situation, Liese said.
The objective is to give companies producing medical devices more flexibility under the current exceptional circumstances and speed up regulatory approval in order to get new devices on the European market more quickly.
“European bureaucracy shouldn’t stop the production of the necessary equipment to fight the crisis,” Liese said.
MedTech Europe, the European trade association for the medical technology industry, recently issued a statement calling on the European Commission and EU member states to “remove any barrier” undermining the industry’s capacity to help manage the current unprecedented public health emergency.
“The medical technology industry has geared up its capacity to a maximum, and is fully committed to bringing to healthcare professionals, patients and member states all the support they need to contain and combat the virus,” said Serge Bernasconi, CEO of MedTech Europe.
“We call on the EU and national health authorities to rapidly address both the challenge of availability of reliable IVD tests and any national decision which interferes with the access of Personal Protective Equipment (PPE) in Europe by preserving the spirit of the EU Internal Market,” he added.