Another essential milestone on our IVDR journey!

We are thrilled about the designation of mdc medical device certification GmbH as the 9th EU-IVDR Notified Body.

Congratulations on this achievement!

This is a major milestone, but we know all too well the challenges that SMEs like us face in navigating the new regulatory landscape.

Increased regulation, legal complexities, and a lack of infrastructure are only some of the obstacles that came along with the implementation of the IVDR and have made it difficult for many small and medium-sized companies to comply. The waiting period for approvals has been especially hard, and we know that many SMEs have been struggling to keep up.

Therefore, this milestone marks a crucial step forward in the implementation of IVDR.

We are looking forward to working with mdc on our first IVDR registration.

BIOTYPE is committed to providing our customers with the best possible products. Therefore, we face these challenges and continue to successfully navigate the changing regulatory landscape.