MHRA Guidance on a No-Deal Brexit

Europe – MHRA Guidance on a No-Deal Brexit

MHRA will take on responsibility for the UK market; The CE Mark remains valid in the UK and no label changes are foreseen...
European Commission Requirements for Marketing Medical Devices in a No-deal Brexit Scenario

Europe – European Commission Requirements for Marketing Medical Devices in a No-deal Brexit Scenario

Definition of “placing on the market” linked to economical ownership; Economical ownership only counts for goods already produced; CE Mark certificates of UK-based...
FDA issues final guidance on devices containing animal-derived materials

USA – FDA issues final guidance on devices containing animal-derived materials

FDA has issued final guidance on medical devices containing animal or animal-derived materials. The guidance supersedes the version issued in 1998 and expands...
Brexit delay: Reduced risk of no-deal withdrawal for medical device manufacturers?

Europe – Brexit delay: Reduced risk of no-deal withdrawal for medical device manufacturers?

No Brexit on March 29th; Vote set for next week on agreement in UK parliament; Delay until May 22rd with conditions; New Brexit day...
EU MDR/IVDR Coordination Group Urges Exemption Clarification

Europe – EU MDR/IVDR Coordination Group Urges Exemption Clarification

The European Commission (EC) issued a new document Friday in which the group established by the EU’s new medical device regulations argued that clarification...
FDA’s OCP Works to Modernize Review Functions

USA – FDA’s OCP Works to Modernize Review Functions

Modernized regulatory review functions for drugs and biologics applications were implemented at the US Food and Drug Administration’s (FDA) Office of Clinical Pharmacology (OCP)...
Rationalize Your Labeling Approach to Prepare for the EU MDRs

Europe – Rationalize Your Labeling Approach to Prepare for the EU MDRs

The new European Union regulations for medical devices (EU MDRs) will have major implications for the labeling operations of every medical device manufacturer that...
Dutch regulators weigh in on no-deal Brexit impact for medical device companies

Europe – Dutch regulators weigh in on no-deal Brexit impact for medical device companies

Currently Brexit is planned on 29 March 2019, but it is not clear how this process will be executed. One of the realistic outcomes...
EU Publishes First Corrigenda for MDR, IVDR

Europe – EU Publishes First Corrigenda for MDR, IVDR

As part of an effort to fix the mistakes, inconsistencies and slightly correct the EU’s Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR), the...
New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

UK – New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

With a little more than a week left before the UK could depart from the EU without a deal, the UK’s Medicines and Healthcare...

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