Potential delays to EU MDR for class I medical devices

Our editor Laura Hughes provides a brief summary of EU Medical Device Regulation (EU MDR), class I medical devices and the potential delays to EU MDR for class I medical devices.

In summary, what is EU MDR?

From 26th May 2020 MDR will come into effect in EU Member States. This regulation applies to all manufacturers selling medical devices within Europe and aims to provide greater protection of public health and safety.

What are the reasons for this potential delay?

The European Commission (EC) initiated a corrigendum in May to amend or modify parts of the regulation. This would potentially allow a transitional period of four years for class I devices before the devices are required to meet the new regulation’s standards. This extra time to locate a Notified Body (NB) would probably be welcomed by organisations, as previously class I devices did not require review by a NB.

Which devices are affected?

Class I devices are the lowest class of medical device, and typically have a simple design and provide minimal harm to the user. Examples of class I devices include surgical instruments and endoscopes. Class I devices make up 40% of all medical devices.

Is this a done deal?

No. The draft was initiated earlier this year by the EC, and all member states agreed to it. Now we are waiting to see if the European Parliament pass the corrigendum. The corrigendum is anticipated to take place in November.