UK – MHRA releases spate of new guidelines on decentralized manufacturing
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released six guidelines to clarify expectations and support the new regulatory framework for...
Australia – How to submit a custom-made medical device / patient-matched medical device notification...
The following guide is designed to assist you with completing and submitting a:
• Custom-Made Medical Device (CMMD) notification; and
• Patient-Matched Medical Device (PMMD) transition...
UK – MHRA expected to launch recognition framework for devices
According to Richard Phillips, executive director of the Association of British HealthTech Industries (ABHI), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is...
Euro Roundup: Pharma reform could cause loss of 3 new orphan drugs a year,...
The European Commission’s plan to reform pharmaceutical legislation could cause three fewer rare disease drugs to come to market each year, according to a...
USA – FDA names new head of medical device evaluation and quality
The Food and Drug Administration named Ross Segan as director of the medical device center’s Office of Product Evaluation and Quality (OPEQ), following a...
France – Un pas de plus dans la lutte contre l’endométriose : lancement du...
L’endométriose : une maladie chronique invalidante
L’endométriose est une maladie gynécologique chronique qui touche entre 1,5 et 2,5 millions de femmes en France. Elle se caractérise par la...
Europe – Notified Bodies Survey on certifications and applications (MDR/IVDR)
To support monitoring and analyzing the availability of medical devices on the EU
market in the context of the implementation of medical devices and in...
USA – Considerations for the Conduct of Clinical Trials of Medical Products During Major...
This guidance recommends approaches that sponsors of clinical trials of medical products can consider when there is a major disruption to clinical trial conduct...
Europe – MDCG 2024-8 Rev. 1 Preliminary assessment review template – ...
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed...
Europe – MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus...
The purpose of this consensus document is to describe in detail the pre-application, application processes through which manufacturers may apply to Notified Bodies (NBs)...
