USA – FDA official warns device makers over supply chain risks

Manufacturers and healthcare providers are reverting to old business practices that could jeopardize medical device supply chains in the event of another public health...

Europe – LNE-GMED UK désigné dans le cadre de la réglementation britannique relative aux...

En décembre 2023, LNE-GMED UK, filiale GMED du groupe LNE a été accrédité par UKAS (United Kingdom Accreditation Service) au titre de la norme...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

Uk – UK approved bodies launch Team-AB as MHRA gears up for new medtech...

Approved bodies (AB) in the UK have come together to launch the UK Association for Medical Device Approved Bodies (Team-AB). It plans to lobby...

Germany – Germany will revise laws for clinical trials with pharmaceuticals, medical devices and...

Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented...
Coronavirus delays many FDA foreign inspections

USA – FDA proposes down-classifying most high-risk IVDs

The US Food and Drug Administration (FDA) intends to reclassify most high-risk in-vitro diagnostics (IVDs) from class III devices to class II moderate-risk devices....

Europe – Experts outline challenges of combination products in Europe

Combination products are increasingly important, increasingly complex and are increasing the pressure on the European regulatory network, according to Thomas Wejs Møller, senior director...
SCCS - Final Opinion on Solubility of Synthetic Amorphous Silica (SAS)

Europe – MDCG endorsed documents and other guidance

MDCG a publié 5 nouveaux documents concernant les conseils de vigilance spécifiques aux dispositifs (DSVG). Le document initial est "MDCG 2024-1 Guidance on the...

USA – FDA updates guidance on remote regulatory assessments

The US Food and Drug Administration (FDA) has revised its draft guidance on remote regulatory assessments (RRAs), outlining how it plans to use both...

Europe – User guide for micro, small and medium-sized enterprises

This guide has been prepared for micro, small and medium sized enterprises (‘SMEs’) operating in the pharmaceutical sector. Its aim is to facilitate understanding...

USA – FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They...

Physicians heavily rely on laboratory tests to make critical decisions about their patients’ care—roughly 70% of healthcare decisions depend on laboratory test results according...

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