Class I Medical Devices Under the EU MDR: Classification Rules and Conformity Assessment
Which MDR Annex VIII rules lead to Class I, typical examples, and how the conformity assessment differs for Class I, Is, Im and Ir devices.
Regulatory News
Global medical device regulatory updates and registration guides
IVDR Registration (Part 7): When Is an In Vitro Diagnostic Device Class A?
The three groups of Class A products under IVDR Rule 5, practical examples, and how classification works for analysers, reagents and accessories used together.
TPMP and PMTA (Part 4): Practical Advice for Manufacturers
How small and medium-sized e-cigarette manufacturers can use the proposed TPMP grace period, the exemption mechanism and smart cost planning to prepare for the US market.
TPMP and PMTA (Part 3): How Manufacturing Practice and Market Authorisation Connect
Why a PMTA and the proposed TPMP rule serve different purposes but depend on each other, and how manufacturers can align both from the start.
ISO 15223-1 Amendment 2025: A New Symbol for the Authorised Representative
ISO 15223-1:2021/Amd 1:2025 adds a definition of “authorised representative” and replaces the EU-specific EC REP symbol with a country-neutral version. What changes on labels.
TPMP and PMTA (Part 1): A Guide to the FDA Tobacco Product Manufacturing Practice Requirements
Background, scope and key requirements of the FDA’s proposed TPMP rule for e-cigarette manufacturers, with documentation, inspection and timeline expectations.
TPMP and PMTA (Part 2): Understanding and Preparing a PMTA for E-Cigarettes in the US
What a Premarket Tobacco Product Application contains, whether clinical studies are needed, how FDA reviews it, and practical tips for applicants.
Exporting IVD Instruments to North America (Part 2): Key NRTL Compliance Points
Why NRTL certification is often overlooked by IVD manufacturers, a typical case of shipment delays, and how to plan certification and factory inspections.
Exporting IVD Instruments to the US: How FDA and FCC Requirements Relate
For IVD instruments with wireless functions, FDA clearance and NRTL certification must be complemented by FCC equipment authorisation and FDA cybersecurity requirements.
Medical Device Cybersecurity in Focus: Lessons from the CMS8000 Patient Monitor Vulnerabilities
What the FDA’s January 2025 safety communication on the CMS8000 patient monitor revealed, and how FDA, EU and NMPA cybersecurity requirements have tightened.