As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – Europe’s MDCG clarifies IVDR requirements for using medical tests in clinical trials

Now that the IVDR 2017/746 has taken effect, new guidance for in vitro diagnostic (IVD) manufacturers with assays used in clinical trials has been published. Assays...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – 37 ème organisme notifié au titre du Règlement 2017/745

37 ème organisme notifié au titre du Règlement 2017/745
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...
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) on March 11th, 2020

Europe – European Council members support proposal to delay MDR deadlines

European Council members expressed support for a proposal by the European Commission to delay the transitional deadlines for medical devices under the Medical Devices...
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...
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) - updated information

Switzerland – Dealing with certification gaps (MDCG 2022-18)

Medical devices can only be placed on the market if the manufacturer has carried out the necessary conformity assessment procedure. For medical devices in...

Europe – Pediatricians push for urgent action to stop MDR from disrupting medical device...

The European Academy of Paediatrics (EAP) has warned urgent action is needed “to secure continued access to essential medical devices for children and for...

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...

Europe – MDCG raises alarm over lack of MDR, IVDR applications

The European Commission’s Medical Device Coordination Group (MDCG) is telling medtech manufacturers to get certified under the new device and diagnostics regulations as soon...

Spain – AEMPS-affiliated notified body becomes first Spanish group designated under MDR

A notified body associated with the Agency of Medicines and Medical Products (AEMPS) has become the first Spanish group designated to assess products under...

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