Will your MDD certificate be valid for longer or even be relived today?

A brief market update from Beat Keller, Head of Regulatory Affairs and Quality Management at IMT.

Today, the new transitional periods have been published in the Official Journal of the European Union. This means that:

- If you are an MDD Class I device manufacturer and newly under the MDR require a notified body, you may now have time until 31st December 2028.
- If you are a Class III or IIb implantable manufacturer, you may now have time until 31st December 2027.
- If you are a Class IIb non-implantable or Class IIa manufacturer, you may now have time until 31st December 2028.

Be aware that there are some restrictions in order to use these time extensions - for example, your QMS needs to be MDR compliant by May 2024 and you need to be in the loop at a notified body.

Do you need support implementing MDR into your QMS? Get in contact with our experts at IMT and we will be happy to help you find a way together to keep your products on market.

Read more on the Official Journal of the European Union (source): https://lnkd.in/e2XAda2x