Contingency legislation covering regulation of medicines and medical devices in a no deal scenario

UK – Contingency legislation covering regulation of medicines and medical devices in a no...

Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality,...
EC Reiterates: All Batch Testing Must be Transferred From UK to EU by 2020

Europe – European Commission clarifies medical device vigilance requirements

The European Commission has published new guidance clarifying manufacturers’ obligations under the Medical Device Vigilance System established by the Medical Devices Directive (MDD). The guidance augments issues...
Who's calling the shots in European healthcare?

Europe – State of flux: European Notified Body numbers decrease further ahead of...

The European Notified Body (NB) landscape remains in uncertain territory as additional entities opt out of designation to the Medical Devices Regulation (MDR) and...
The Human Medicines and the Medical Devices Regulations 2019

UK – The Human Medicines and the Medical Devices Regulations 2019

These Regulations, which come into force immediately before exit day, are made to correct drafting defects and omissions in the Human Medicines (Amendment etc.)...
Why Industry Anticipates a ‘Cliff-Edge’ Scenario With EU MDR/IVDR

Europe – Why Industry Anticipates a ‘Cliff-Edge’ Scenario With EU MDR/IVDR

The EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) may cause a “cliff-edge scenario,” meaning a disruption in the supply of certain medical devices and...
EC Reiterates: All Batch Testing Must be Transferred From UK to EU by 2020

Europe – Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev....

This document provides additional guidance in relation to the Medical Device Vigilance System that is currently in operation under the Medical Devices Directives. The...
Call for applications: observers for the nomenclature sub-group of the medical device coordination group

Europe – Call for applications: observers for the nomenclature sub-group of the medical device...

This working group shall assist and advise the MDCG on all implementation issues related to the medical device nomenclature to support the future European...
EU Drug Shortage - The Impact of Brexit on Both the UK and EU-27 Member States

UK – UL UK to Sunset Operations Under EU’s Medical Device Directive

UL UK says it will no longer operate as a notified body (NB) under the EU’s medical device directive (MDD) and limit its work...
NICE expands draft recommendation for Lokelma

UK – Device for preventing and relieving pain of cluster headaches approved by NICE...

The recommendation is made in NICE’s draft medtech guidance published today (5 July) for public consultation. It highlights that using gammaCore in addition to...
Liste des Produits LPPR nécessitant un code d’identification individuel

France – Liste des Produits LPPR nécessitant un code d’identification individuel

Art. 1er. – En application de l’article R. 165-87 du code de la sécurité sociale, l’annexe au présent arrêté fixe la liste des descriptions...

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