Double peine pour la medtech suisse

USA – Switzerland eyes allowing FDA-approved medical devices onto its market

The Swiss parliament has asked the country’s Federal Council to adapt its laws to allow medical devices that have been vetted by non-European regulators,...

Europe – Artificial Intelligence Act : un nouveau règlement européen à suivre de près

L’AIA est une proposition de règlement du parlement et du conseil européens dévoilée le 21 avril 2021, dont l'entrée en vigueur est programmée dans...
Advice for Management of Clinical trials in relation to Coronavirus

UK – Borderline products: how to tell if your product is a medical device...

Some products are hard to distinguish from a medical device, for example products that might be medicines, cosmetics, food supplements, biocidal products or personal...
MHRA Offers Advice on use of Brand Names to Prescribe Drugs

UK – Register medical devices to place on the market

All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in...
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) - updated information

Europe – Accord avec le Royaume-Uni relatif à la reconnaissance mutuelle en matière d’évaluation...

Depuis le retrait du Royaume-Uni de l’UE, l’accord entre la Suisse et l’UE relatif à la reconnaissance mutuelle en matière d’évaluation de la conformité...

Europe – Lancement d’un groupe de travail européen sur l’évaluation des DM numériques (ANS)

PARIS (TICpharma) - Un groupe de travail européen sur l'évaluation des dispositifs médicaux (DM) numériques a débuté ses travaux en vue de "parvenir à...
DEKRA accredited under the MDR

Europe – European Notified Body survey: MDR, IVDR certification numbers remain low

A new survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification...
SCCS - Final Opinion on Solubility of Synthetic Amorphous Silica (SAS)

Europe – Notified bodies survey on certifications and applications

Notified Bodies Survey on certifications and applications (MDR/IVDR) - MDCG & Stakeholders...

UK – New device launched for diagnosing prostate cancer

CamPROBE may save vital time and money while reducing the risk of infection November will witness the launch of a new device that is set...
Opinion On Allergy Alert Test (AAT) as a proof-of-concept study

Europe – MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical...

Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if...

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