Medical device industry is witnessing rapid Regulatory reforms, thanks to evolving technologies and scientific developments. In this rapid development scenario, to aid medical device manufacturers, notified bodies, and other stakeholders align with the sophistication and globalization, Regulatory bodies are parallelly revamping the compliance standards. Same is the case with EU MDR which will come into effect from May 26, 2021, with new regulations, to increase the safety, accountability, transparency and traceability of medical devices.
The MDR underlines the essential requirements, General Safety and Performance Requirements (GSPR), classification rules, conformity assessment procedures, Quality Management System (QMS) and clinical investigations for medical devices. Given the complexity of implementing the EU MDR changes, the medical devices community must understand and comply with the new regulations, to avoid last minute challenges and to ensure a successful market-entry. En-route, manufacturers must understand:
- The EU MDR Requirements for Various Device Classes
- Class I Medical Devices - What’s different from EU MDD?
- Clinical and Safety Requirements Under EU MDR
- QMS Compliance – ISO 13485:2016 and MDSAP – Impact of EU MDR
- European Authorized Representation – Additional Responsibilities Under EU MDR
- Notified Bodies – Key Considerations
To navigate the MDR transition with ease, what are the considerable Regulatory strategies to be followed by the manufacturers? What is new under the MDR and how is it different from the existing MDD? Decode comprehensive insights with Freyr’s exclusive webinar session on, “EU MDR Compliance of Medical Devices”, scheduled on October 7, 2020, 10:00 AM EST/EDT | 3:00 PM BST | 7:30 PM IST.