MDR Resource Center

EU Medical Devices Regulation 2017/745 (MDR) resource center

In May 2021, the European Medical Devices Regulation 2017/745 (MDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how medical device manufacturers obtain CE Marking and maintain access to the European market, and yet a majority of companies may have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies.

Are you prepared?

Learn how far your company has to go to reach MDR compliance with our MDR Readiness Checklist.

GET THE CHECKLIST

Key MDR compliance requirements and challenges

An effective roadmap to MDR compliance involves multiple components. MDR requirements, such as conformity assessments and sufficient clinical evidence, are more expansive and complex than those of the MDD, which means manufacturers must now address issues including:

Total product lifecycle approach to CE Marking certification
Learn how MDR affects human factors engineering and usability requirements via our this webinar
Enhanced post-market surveillance and post-market clinical follow-up (PMCF) requirements
Notified Body capacity: When does your NB plan to obtain MDR designation?
Changes to European Authorized Representative (AR) roles and agreements
Eudamed database submission requirements for manufacturers, devices and other economic operators

Download our MDR Readiness Checklist?to quickly assess your level of compliance with the new regulation and identify next steps.

How we help

Emergo by UL consultants are ready to fully support your CE Marking transition from the Medical Devices Directive (MDD) to the MDR.

EU MDR 2017/745 Gap Assessment and CE Transition Strategy for Medical Devices

Let us provide a systematic plan for your company to achieve compliance.

European Authorized Representative for Medical Device Companies

Emergo by UL is an EU Authorized Representative to over 1000 medical device companies.

European Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices

Our medical device CRO can design and execute your PMCF study in accordance with EU MDR 2017/745 requirements.

On-Site Medical Devices Regulation (EU MDR) Training for Manufacturers

Gain an in-depth understanding of the MDR through an on-site training session with one of our expert consultants.

MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER) for Medical Devices

We specialize in reviewing clinical data and can ensure that your report meets European requirements.

EU MDR compliance consulting for cosmetic and aesthetic products

Emergo by UL can recommend the most effective path to update your processes.

Our MDR Team

Our EU consultants have decades of experience in medical device regulatory affairs, human factors, clinical research, and cybersecurity. Meet our MDR team