BRUSSELS (dpa-AFX) - To prevent possible bottlenecks in the supply of medical products, the EU Commission wants to extend transition periods for their certification. This is to allow more time for the changeover to new EU rules, as the Brussels-based authority announced on Friday. Many manufacturers are not sufficiently prepared to implement the requirements by the end of the transition period originally set, it said.

New safety rules will apply to medical devices ranging from adhesive plasters to hip joints in the European Union from May 2021. The reform is the consequence of the breast implant scandal more than ten years ago. Since then, high-risk products such as implants must be assessed by EU experts before they are launched on the market. Assessments, tests and the bodies that are allowed to issue certificates for medical devices are monitored more closely.

Manufacturers and also users such as hospitals had criticized the reform because of the additional effort required for certification and warned of bottlenecks.

According to the Commission's proposal, a transition period for so-called high-risk products such as implants is now to be extended until December 2027. Originally, the deadline was to end as early as May 2024. For products with medium or low risk, for example syringes, the authority proposes an extension until December 2028. Medical devices that received a certificate or were declared compliant with the rules before May 26, 2021, would be affected. EU member states and the European Parliament must still approve the proposal.

CSU European politician Angelika Niebler welcomed the Commission's move. "The amendment of the Medical Devices Regulation is an important step towards greater patient safety in the EU," Niebler said. She said there was an urgent need to ensure the supply of medical devices and to ease the burden on businesses./bum/DP/ngu