USA – FDA official discusses use cases, limits for device PCCPs
While predetermined change control plans (PCCPs) may not typically be appropriate for changes to a device’s indications for use, they can be useful for...
usa – Industry calls for changes in FDA’s RWE guidance for devices
Medical device industry groups say the US Food and Drug Administration’s (FDA) draft guidance using real-world evidence (RWE) to support regulatory decision making for...
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...
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...
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...
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The US Food and Drug Administration (FDA) has revised its draft guidance on remote regulatory assessments (RRAs), outlining how it plans to use both...
