Europe – EMA revises Q&A guidance on drug-device combination products
The European Medicines Agency and the Co-ordination Group for Mutual Recognition and Decentralized Procedures (CMDh) have issued a revised guidance that clarifies the information...
Europe – Notified bodies concerned with lack of MDR/IVDR applications as deadlines approach
Notified body (NB) capacity has risen significantly in recent years as the number of designations has increased; however, some manufacturers have yet to transition...
Europe – Medical devices: new guidance for industry and notified bodies
A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices has been published today. This question-and-answer document provides practical considerations on the...
UK – EM on EU regulations 2017/745 & 2017/746 (COM(2024)43)
This explanatory memorandum is about a European Commission for a proposal for a regulation of the European Parliament and of the Council amending regulations (EU)...
Europe – EU report examines barriers to combined studies of drugs, IVDs, and devices
A lack of alignment between the Clinical Trials Regulation (CTR) the In Vitro Diagnostic Medical Device Regulation (IVDR), and the Medical Device Regulations (MDR)...
UK – MHRA’s AI Airlock to address challenges for regulating AI medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock, a new regulatory sandbox, to address the challenges of regulating medical devices...
Europe – Commission welcomes adoption by European Parliament of measures to improve the availability...
The Commission welcomes the adoption by the European Parliament today of measures, proposed by the Commission in January 2024, to improve the availability of in vitro diagnostics...
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...
Europe – Désignation d’AFNOR Certification dans le cadre du règlement UE 2017/745, relatif aux...
Désignation d'AFNOR Certification dans le cadre du règlement UE 2017/745, relatif aux dispositifs médicaux...
Europe – MDCG 2024-5 guidance on content of the Investigator’s Brochure for clinical investigations...
When a sponsor of a clinical investigation shall submit an application according to article 70(1) of the MDR, the application shall be accompanied by...
