The European Medical Device Regulation (MDR 2017/745)

 

 

28.08.2019

MEDIACC is well prepared for the implemementation of the European Medical Device Regulation (MDR 2017/745) for Clinical Evaluations, Clinical Studies, Post-Market Clinical Collow-up (PMCF) and Post-Market Surveillance (PMS).

Time flies for manufacturer of medical devices and developers of medical apps. The EU MDR 2017/745 will be applicable on May 26th 2020. Transitional arrangements are put into place by the Notified Bodies. However, for medical devices requiring Clinical Studies, the MDR is binding in case last patient / last visit is not finished by this date.

MEDIACC’s employees now received the certificate on Clinical Evaluation and Clinical Studies according to EU MDR 2017/745 by Germany’s first and only designated Notified Body for EU MDR, TÜV Süd. As certified partner on the side of our clients, we make sure to striktly comply with international standards such as the Declaration of Helsinki, Good Clinical Practice (GCP) and ISO 14155:2011 as well as implement necessary changes as mandated by the new regulation to protect patients’ rights and safety and increase medical device effectiveness in the EU market.

An interesting feature in our view is that the Medical Device Regulation contains words such as “Safety”, “Clinical Data”, “Clinical Evaluation” and “Post Marketing Surveillance” are at least seven time more often than in the Medical Device Directive (MDD 93/42/EEC).