Navigating the many requirements set forth within the European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) can be overwhelming for even the best-prepared medical device or IVD manufacturer.
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies on a daily basis. Our internal team of nearly 100 global regulatory experts is partially comprised of authorities from five leading Notified Bodies—putting this knowledge and expertise to work for you—ultimately delivering clients accelerated and cost-efficient regulatory outcomes.
Do you have the right regulatory partner to help you meet compliance and stay ahead of the competition? Contact us today to learn the critical steps you should take now to achieve regulatory conformity and market success.
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies on a daily basis. Our internal team of nearly 100 global regulatory experts is partially comprised of authorities from five leading Notified Bodies—putting this knowledge and expertise to work for you—ultimately delivering clients accelerated and cost-efficient regulatory outcomes.
Do you have the right regulatory partner to help you meet compliance and stay ahead of the competition? Contact us today to learn the critical steps you should take now to achieve regulatory conformity and market success.
NAMSA, in an effort to assist global medical device and IVD manufacturers with compliance planning, has made available several complimentary resources which can be found below. We hope you find these tools to be beneficial as you prepare for implementation of the new MDR/IVDR regulations.
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+1 419.666.9455 (outside of USA)
MDR / IVDR Planning Resources
In July 2018, the EU Commission issued the following “Information to Manufacturers” in an effort to provide further clarity on new regulatory changes and implementation models to address the regulations:
- IVD Clinical Trials: Essential Components for Product Launch in 2019 and Beyond
- EU MDR: General Safety & Performance Requirements for the Biocompatibility of Medical Devices
- EU MDR: Optimizing Clinical Evaluation Reports (CERs) within the Medical Device Lifecycle
- Leveraging Post-Market Surveillance & Clinical Follow-Up Data to Support EU MDR Compliance
- EU IVDR: Top 5 Changes for Medical Device Manufacturers to Consider
- EU Commission Updates Website to Provide Additional MDR & IVDR Planning Resources (Jan. 2019)
- Renewal Timelines Quickly Approaching for Medical Device Directive (MDD:M5) CE Mark Certificates (Jan. 2019)
- EU Commission and MDCG Release New MDR/IVDR Guidance Documents (Oct. 2018)
- CE Marketing of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR (April 2018)
- UK MHRA Publishes Guide to the New EU MDR AND IVDR (Sept. 2017)
- EU MDR Poses Significant Changes for Importers and Distributors (July 2017)
- MDR Transition Timelines for Legacy Medical Devices – Not without Risks and Undue Burden (April 2017)
- Exhaustive List of Requirements for Manufacturers of Medical Devices
- Implementation Model for Medical Devices Regulation: Step by Step Guide
- Fact Sheet for Manufacturers of Medical Devices
- Implementation Model for In-Vitro Diagnostic Medical Devices Regulation: Step by Step Guide
- Fact Sheet for Manufacturers of In-Vitro Diagnostic Medical Devices
- Field Safety Notice (FSN) Guidance Documents