Obelis O.E.A.R.C.

Legal Challenges at time of Non-Renewal of a CE certificate

In order to place a medical device on the European Market a manufacturer needs to be in conformity with the applicable European regulation. In this case in compliance with the Medical Device Directive.

One of the requirements for upper Class devices (Class IIa, IIb or III) is to obtain a CE certificate issued by a European Notified Body – the CE certificate has a time and activity related validity. Based upon his certificate the manufacturer is allowed to place medical devices in the European market.

What happens if the CE certificate is NOT renewed?

1. Is the manufacturer allowed to place NEW devices on the market?
2. What about the existing devices already on the market? Should the manufacturer recall his devices? What are the manufacturer’s responsibilities?
3. Can the manufacturer change his claim and therefore affix the CE marking based on another Directive?

Obelis Senior Regulatory Expert, Dr. Peter Ruys provides his view on these important questions;

1. The day after the termination of the certificate he is not allowed to export to the EU. He shall specify the last serial number or batch number produced and make a formal statement that no other medical devices will be brought to the EU as per the mentioned CE certificate.

2. The existing devices are in the distribution channel out of his ownership. Nevertheless the manufacturer still has responsibilities towards them:

- The Manufacturer is s till liable for the product during t he lifetime of the last shipped product.
- The Manufacturer is still required to keep the technical documentation readily available for competent authorities (in case of Non-E U manufacturers via his Authorized Representative) for the period mentioned in the Directive- at least 5 (five) years after the last device has been manufactured or 15 (fifteen) years after the last device has been manufactured, in case of implantable devices.
- The manufacturer is still responsible for maintenance and having spare parts for the devices on the market.
- As per the above, in case the CE certificate is not renewed, the manufacturer is still required to have an agreement with a European Authorized Representative in place for the required time period.

3. The Manufacturer is allowed to change his specifications and claims and bring the product to the market in accordance with another directive. It shall be clear in his marketing and sales activities that he is no longer focusing on the medical market, BUT – He cannot change the history: devices already on the market as medical devices are and will stay medical devices.