The European Commission has adopted a proposal to grant more time to companies to comply with the new medical devices regulating law to prevent shortages of lifesaving equipment.
The proposal adds a longer transition period for complying with new regulations as instructed under the Medical Devices Regulation.
As per the Commission, the revised deadlines are based on the risk category of the medical devices and will maintain patients’ access to those devices.
The length of the proposed extension of the transition periods for medium- and low-risk devices will have a longer transition period until December 2028 and higher-risk devices will have time till December 2027.
In addition, the proposal unveiled a transition period until 26 May 2026 for class III implantable custom-made devices. The Commission also plans to eliminate the ‘sell-off’ date currently established in the Medical Devices Regulation and in the In Vitro Diagnostic Medical Devices Regulation.
The Commission said that the European Parliament and the Council must now approve the plan via an expedited co-decision procedure.
EU Health commissioner Stella Kyriakides said: “Our rules on medical devices will always prioritise patient safety and support for innovation. A combination of factors has left healthcare systems across the EU facing a risk of shortages of life-saving medical devices for patients.
“Today, we propose a revised regulatory timeline to provide certainty to the industry in order to continue producing essential medical devices, reducing any short-term risk of shortages and safeguarding access for patients most in need.”
The proposal was tabled last month, citing difficulties in implementing the law were threatening supplies of critical devices like catheters used for surgeries on newborns with heart conditions.
According to the EU governing body, the bill does not change any of the existing safety and performance criteria mentioned in the Medical Devices Regulation.
The Medical Devices Regulation was adopted in 2021 to set a conformity assessment system to maintain the quality, safety, and performance of devices placed on the EU market.
