EU Medical Devices Regulation 2017/745 (MDR) preparation support and resources

In May 2020, 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.

Even though time is limited, Emergo by UL consultants are ready to fully support your CE Marking transition from the Medical Devices Directive (MDD) to the MDR, and can develop your strategy based on your medical device product range, CE Marking certification cycles, Notified Body partnerships and Supply Chain structure.

Key MDR compliance requirements and challenges

An effective roadmap to MDR compliance involves multiple components. MDR requirements including 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
• 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
• New products in MDR scope, including cosmetic and aesthetic products

Emergo by UL consultants in Europe and around the world can provide training and CE Marking transition strategy support in order to ensure your compliance to the MDR in time for the Regulation’s May 2020 application date.

MDR resources

• Whitepaper: Understanding Europe’s new Medical Devices Regulation
• Whitepaper: PMS and PSUR requirements under the EU MDR
• Whitepaper: PMCF studies under the EU MDR
• Whitepaper: Preparing to change your European Notified Body
• Whitepaper: Conformity assessment routes under the EU MDR
• Webinar: The new European MDR
• Webinar: Eudamed requirements under the EU MDR and IVDR
• Webinar: PMS and PMCF under the EU MDR
• Regulatory process chart: EU MDR CE Marking regulatory process

MDR news and analysis

• EU MDR guidance on medical device implant cards
• Notified Body numbers decrease ahead of MDR
• EU MDR guidance on persons responsible for regulatory compliance (PRRC)
• Increased clinical evidence requirements under the EU MDR
• Spotlight on PMCF requirements under the EU MDR