We continue to obtain CE certificates for additional products under the new European Medical Device Regulation (EU) 2017/745

We have good news once again! We continue certifying DIMA products under the MDR regulation. This year, two products have obtained certification: one for male urinary incontinence (Male Remeex System) and another for vaginal prolapse (Surelift Anchorsure).

What is the MDR?

The Medical Device Regulation (EU) 2017/745 is the (relatively) new European regulation governing medical devices. It defines the requirements and obligations that all manufacturers and distributors must comply with in order to market a medical device within the European market.

In addition to integrating the previous Directives 90/385/EEC and 93/42/EEC, this regulation establishes stricter requirements and control measures, in line with the global evolution of the medical device market.

Currently, we are in a transition period, which has been extended by the European Commission until 2027 to ensure that Europe does not face shortages of medical devices, as the certification process is complex and demanding.

DIMA has made a strong start with MDR certifications, and we expect to submit the technical documentation for additional products in the near future.