Clinical evaluation

Medical devices must be safe and perform well. To prove this, a clinical evaluation is required. The European Medical Device Regulation (MDR) 2017/745, like the still valid EU Medical Device Directive (93/42/EEC, MDD), requires that all medical device manufacturers to conduct a clinical evaluation and post-market clinical follow-up (PMCF) for all their devices, regardless of risk class. The clinical evaluation is an essential part of the conformity assessment procedure for CE marking and must be performed before the approval and the placing on the market.

What to Expect

Key Topics: Current developments and challenges in the field of clinical evaluation and beyond.
In-Depth Exchange: In addition to clinical evaluations, we’ll cover PMCF planning, SSCP preparation, and other relevant topics in the realm of Clinical Affairs.
Valuable Insights: Practical anecdotes and creative approaches to common challenges.
Strategic Advice: How to effectively navigate interactions with notified bodies and reviewers – practical tips to streamline your processes.
Open Q&A Session: Get answers to your most pressing questions in a relaxed and open atmosphere.

When and Where?

Once a month, always on Mondays
From 11:30 AM to 12:30 PM

Dates:

January 13 / February 10 / March 10 / April 14 / May 12 / June 16 / July 14/ August 11 / September 12 / October 13 / November 10 / December 8

Held conveniently via Microsoft Teams – no registration required!

Join the meeting HERE

Can’t make it to our Monday consultation?

No problem – schedule a free introductory meeting with us via the booking link

or take part in our free mini-course on clinical evaluation.

Click HERE to register

Training Courses

MEC-Academy GmbH, a subsidiary of MEC-ABC GmbH, offers hands-on courses in the field of Clinical Affairs for medical devices.

www.mec-academy.de

Contact

MEC-ABC GmbH
Aachener-und-Münchener-Allee 9
52074 Aachen

Tel.: +49 241-51967486
Mail: info@mec-abc.de

Information

Business services

MDR

The MDR is mandatory from 26 May 2021 after a four-year transition period.

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