Practical perspectives on medical device regulation
Insights to navigate regulation, bring medical technologies to market, and improve patient care.
EU Authorised Representative
Navigating the complexities of EU medical device regulations is crucial for manufacturers, particularly those outside the European Union.
PRRC Liability: What Happens If You Get It Wrong?
How PRRC liability actually works, including Italy's example of fines up to €120,000, and what it means for the person holding the role.
Team NB's Best Practice Guidance v3, Explained
What changed between v2 and v3 of Team NB's Best Practice Guidance for MDR technical documentation, and what it means for claims management.
EU Authorised Representative for Medical Devices
What an EU Authorised Representative does, when you need one, and how to choose the right partner under EU MDR.
Declaration of Conformity Template: UK and EU
Free declaration of conformity templates for UK and EU medical devices, with guidance on what each version requires.
Is ISO 13485 Required for CE Marking?
A clear answer on whether ISO 13485 certification is required for CE marking medical devices under EU MDR.
EU Regulation 2024/1860 and Device Shortages
What EU Regulation 2024/1860 means for medical device availability and what manufacturers and economic operators should know.
Regulatory Compliance Strategy for EU MDR
A practical approach to building a regulatory compliance strategy under EU MDR, from classification to post-market obligations.
Are Harmonised Standards Mandatory? MDCG 2021-5
MDCG 2021-5 Rev 1 confirms using a standard is voluntary, but notified bodies can still assess against one you haven't applied.
UK and EU MDR Regulatory Changes, Late 2022
A round-up of UK MDR timeline changes, EU MDR Annex XVI common specifications, and staggered EU MDR transition deadlines from late 2022.
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