Medical Device Compliance

Understanding MDR and IVDR Compliance for Medical Device Manufacturers

A guide to navigating MDR, IVDR, and ISO 13485 requirements for medical device manufacturers operating in the European market.

Key regulations

EU MDR / IVDR

The EU Medical Device Regulation and In Vitro Diagnostic Regulation define requirements for the entire product lifecycle — from classification and conformity assessment through to post-market surveillance and vigilance reporting.

ISO 13485

The international standard for quality management systems in the medical device industry. It covers design controls, document management, risk management, and supplier oversight.

EUDAMED

The European database for medical devices requires manufacturers to register devices, assign UDIs, and submit vigilance and post-market data to a centralised system.

Notified body certification

Medical device manufacturers must work with designated notified bodies for conformity assessment, requiring structured technical files, clinical evaluation reports, and audit-ready documentation.

Key compliance challenges

•Managing hundreds of interconnected requirements across MDR, IVDR, and ISO 13485 simultaneously, with overlapping documentation obligations.
•Keeping technical files and clinical evaluation reports current as regulations evolve and notified body expectations shift.
•Coordinating post-market surveillance activities, vigilance reporting, and EUDAMED submissions across multiple product lines.
•Preparing for notified body audits while maintaining day-to-day compliance operations without disruption.

Want to stay informed?

Read our latest insights on medical device regulatory compliance.

Browse MedTech articles →