Complying with the EU MDR: New Guidances, Standards and Procedures
One thing is certain after a year of the EU Medical Device Regulation (MDR): compliance is still a moving target.
With new developments happening almost daily — guidances, standards, Medical Device Coordination Group (MDCG) interpretations, notified body interpretations — compliance feels shaky.
You can keep up with the ever-evolving MDR with Complying with the EU MDR: New Guidances, Standards and Procedures.
This management report details the factors that are likely to affect MDR compliance and clarifies how they all work together so you can continue your EU operations … no matter how many changes you must consider.
And you must consider them all: not only the common specifications, guidances and harmonized standards, but various interacting EU laws that most devicemakers are only vaguely aware of, including the forthcoming Artificial Intelligence Act, cybersecurity frameworks, data protection laws and hazardous substance requirements.
You need well-designed tools and systems to follow regulatory updates of all types, set equivalence requirements, compliantly manage changes to standards and medical state-of-the-art good practices. If you don’t, compliance will be difficult, at best.
Complying with the EU MDR will give you the ability to track modifications in all of these areas and empower you to adapt quickly and smoothly so you can comply with the entirety of the MDR. It will also shed light on the technologies available that can help you do this, including regulatory intelligence systems and regulatory affairs software.
Management Report Takeaways:
- The nine crucial parts of an effective MDR regulatory compliance process
- What various guidances and interpretations (e.g., notified body, competent authority, MDCG guidance) currently have to say about applying the MDR — including the value and pitfalls of each
- Scenarios that may impact your regulatory compliance strategy, including EMA guidance, new or amended EU laws, standard harmonization requests, introduction of implementing acts, a new notified body and more
- How to develop agile systems that can respond appropriately to shifting requirements
- How technology can help support your regulatory compliance strategy and system, including use of data repositories, monitoring tools and RSS feeds
Get a clear understanding of the entire regulatory framework surrounding the MDR and implement well-designed tools and systems to track the updates. Keep up — and stay compliant — with Complying with the EU MDR: New Guidances, Standards and Procedures.
About the Contributor
James Pink, senior director of medical at Element Materials Technology, has more than 25 years of experience in medical technology product safety, quality and regulation, including 10 years at the BSI Notified Body. He is an active participant in future medical technology regulation and standards, with significant experience of European regulation, the operation of notified bodies and product liability in the field of medical devices.
Who Will Benefit
- Development directors/engineers
- Quality assurance personnel
- Regulatory affairs personnel
- Clinical associates
- Research and development personnel
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