EU Parliament extends deadlines for the Medical Devices Regulation
Mit has a large majority Eu Parliament on Thursday, the Medical Devices Ordinance passed in April 2017 was changed: the stricter requirements provided for in the law are now only to take effect for existing products from the end of 2027 or the end of 2028. Manufacturers and many doctors had warned that vital products such as stents, catheters or implants would otherwise no longer be available. Significantly more evidence and documents now have to be submitted for the approvals, the tests are more complex – and the responsible bodies are overburdened.
“This decision saves lives,” said MEP Peter Liese (CDU), who had previously advocated stricter rules. But due to too much bureaucracy, this “emergency operation” was now necessary. He is committed to introducing further exceptions for niche products for which the certification effort is not worthwhile.
“The actual objective of the regulation, to ensure the safety of medical devices, is still the right one,” said Stefan Sauerland from the Institute for Quality and Efficiency in Healthcare – manufacturers would have exaggerated the problems in some cases. Warnings were given in particular about the failure of medical products for children.
The amendment to the regulation still has to be approved by the European Council. This is considered a formality in Brussels; the decision is scheduled for a meeting of EU education ministers in early March.