The EU Commission will be postponing the implementation of new regulations regarding medical devices for one year. The rules will become effective as Norwegian law without revisions, and the planned implementation was in May of this year. It now looks like it will be postponed until May of 2021.
Medical devices are defined as all devices that a manufacturer produces for human application to diagnose, prevent, monitor, treat or relieve illness, injury or handicap. They range from contact lenses and pacemakers to glucose meters. There are about 25 000 manufacturers in Europe, of which about 80 are small companies. The industry employs more than 500,000 people, and annual turnover is about 95 billion Euro. The EU accounts for about 33 per cent of the total global market.
The purpose of the new rules is to improve patient safety and ensure a uniform regulatory framework for the EEA area. In other words, no single country will be able to introduce stricter or more lenient rules pertaining to medical devices. Some of the stated goals for the new regulations have been to:
- establish uniform supervision of regulatory agencies;
- establish a legally predictable framework;
- find solutions in borderline cases;
- improve traceability of medical devices in the European market;
- increase the use of external and clinical expertise;
- establish clear obligations and liability for market participants; and
- ensure effective governance and cooperation between member states.
As a result of the Covid-19 crisis, the EU Commission announced on 25 March 2020 that it is working on postponing the effective date for one year. The commission’s specific proposal is expected in early April. The goal is to free up resources for authorities and manufacturers of medical devices so that they may prioritise work on resolving the Covid-19 crisis.
The implementation of specific regulations relating to in vitro diagnostic devices will, as far as we can tell, take place as planned in May 2022.
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