Medical Device Certification to Become More Stringent

Manufacturers and suppliers of medical devices must prepare themselves for the challenges posed by the new EU Medical Device Regulation (MDR): The certification procedures will be regulated more strictly and with more stringent demands than before. DEKRA will provide information on the current trends and changes in the industry at the MEDICA trade fair in Dusseldorf from November 14 to 17 (hall 10/stand B08).

A dominant topic at the trade fair will be the new EU Medical Device Regulation (MDR), which will soon replace the Medical Device Directive (MDD). The medical device requirements and conformity assessment procedure requirements will be stricter, particularly in the case of high-risk devices. The DEKRA experts recommend that manufacturers examine the drafts of the regulation now, before the regulation comes into effect.

Further focal points of the appearance at the trade fair are changes concerning quality management following the revision of ISO 13485:2016 and upcoming changes in regulations in the case of in vitro diagnostic medical devices. DEKRA experts will answer questions, including on the Medical Device Single Audit Program (MDSAP) as well as on the Japanese Pharmaceutical and Medical Devices Act (PMD).

DEKRA at MEDICA: Hall 10, stand B08

More information and range of seminars:

Tel.: +49 711 7861 2122