Update to the Borderline Manual provides both guidance on product classification and insight into the Working Group thought process.
The European Commission has published an updated version of the Manual on Borderline and Classification for Medical Devices, commonly referred to as the Borderline Manual.
There are six new additions to the Manual, four of which relate to products which the Working Group concludes are not appropriate for classification as a medical device. The route by which the Working Group came to its conclusion concerning the appropriate
Revision to EMA Alzheimer’s Trial Guideline
The European Medicines Agency Guidelines on the clinical investigation of medicines for the treatment of Alzheimer's Disease (AD) were last updated in 2018. The Agency has recently published a concept paper concerning future revision of these Guidelines.
The revisions are, in part, the result of recent advances in the field of AD
MHRA Field Safety Notices – Guidance for Manufacturers
The MHRA has published guidance for manufacturers of medical devices concerning field safety notices. The guidance includes advice regarding the steps to ensure good traceability, and advice concerning various elements of Field Safety Notices (FSNs).
EMA Guideline on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials
The European Medicines Agency (EMA) has introduced a draft new guideline on the inclusion of pregnant and breastfeeding women in clinical trials. The goal is to ensure that developers of clinical trials generate robust clinical data in relation to pregnant and breastfeeding women, so that these individuals and their healthcare providers can make informed, evidence-based decisions when using medicines.
UK Regulations Governing Post-Market Surveillance of Medical Devices Enter Into Force
The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 entered into force on 16 June 2024. The Regulations, which apply in Great Britain, introduce a new Part 4A to the existing Regulations governing post-market surveillance (PMS) requirements for medical devices. These include in vitro diagnostic (IVD) devices and active implantable medical devices.
MDGC Publishes Guidance on Performance Studies for IVDs
The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 entered into force on 16 June 2024. The Regulations, which apply in Great Britain, introduce a new Part 4A to the existing Regulations governing post-market surveillance (PMS) requirements for medical devices. These include in vitro diagnostic (IVD) devices and active implantable medical devices.
FAQ on the Interplay Between the AI Regulation and the IVDR and MDR
The Medical Device Coordination Group (MDCG) and the Joint Artificial Intelligence Board (JAIB) have recently published a FAQ concerning the interplay between the AI Act and the in vitro medical devices Regulation (IVDR) and the Medical Devices Regulation (MDR).
MDCG Guidance on the Safe Making Available of Medical Device Software (MDSW) Apps on Online Platforms
The Medical Device Coordination Group (MDCG) has published MDCG 2025-4, which provides guidance on the safe making available of medical device software (MDSW) apps on online platforms.
Revised Regulation on Instructions for Use in Electronic Form Expands Its Scope of Existing Provisions
The original Regulation governing the provision of instructions for use for medical devices in electronic form was limited in its scope. Although the scope of the Regulation has been expanded, the medical devices in relation to which instructions for use in electronic form were permitted remained limited.
EMA Unveils ERATO its new AI Tool improving Pharmacovigilance Signal Detection
Among the initiatives discussed by the European Medicines Agency (EMA) in its recently published annual report on 2024 activities was its new AI tool Enhanced Review of Abstracts with Transformer models (ERATO).
The purpose of ERATO is to reduce by an estimated 80% to 90% the roughly 200,000 abstracts the EMA Pharmacovigilance Office reviews every year. This could save more
Council of Ministers Agrees its Position for Negotiation of the Pharma Package with the European Parliament
Having agreed its position on the European Commission’s proposal for new legislation governing the regulation of medicinal products, the Council of Ministers has declared that it is ready to begin negotiations with the European Parliament.
Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks
Following publication of a report by the European Federation of Pharmaceutical Industry Associations (EFPIA) in which EFPIA concluded that the EU was becoming a less attractive location for conducting clinical research, the European Commission has told the Pink Sheet that it had heard the concerns raised by stakeholders regarding bottlenecks and regulatory insufficiencies that contribute to a decline in the number of clinical trials conducted in Europe.
Medical Device Post-Market Surveillance Activities in GB
The UK authorities have published guidance concerning the implementation of post-marketing surveillance obligations in relation to medical devices in Great Britain. The regulatory obligations will begin to apply from 16 June 2025.
New Manufacturer’s Incident Report PMSV reporting forms - European Commission (Copy)
The European Commission has published a new reporting template for Manufacturer Incident Reports (MIR) for Serious Incidents (SI). The template will become obligatory in November 2025.
New Manufacturer’s Incident Report PMSV reporting forms - European Commission
The European Commission has published a new reporting template for Manufacturer Incident Reports (MIR) for Serious Incidents (SI). The template will become obligatory in November 2025.
New Guidance Concerning Radiopharmaceuticals Supply Chain
The European Medicines Agency and the Heads of Medicines Agencies (HMA) have published Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to address vulnerabilities in the supply chain of radiopharmaceuticals.
Proposal for Critical Medicines Act
The European Commission has presented its proposal for a Critical Medicines Act. The main purpose of the proposed Act is to limit the EU dependence on third country sources of critical medicines and encourage domestic production.
Update to MDCG Guidance on Classification Rules for in vitro Diagnostic Medical Devices under in vitro diagnostics Regulation
An update to the MDCG Guidance on Classification Rules for in vitro Diagnostic Medical Devices under the in vitro diagnostics Regulation has been published.
New MHRA Guidance concerning extended periods of validity of CE Certificates and Declarations of Conformity for some in vitro diagnostic medical devices
Reflecting the 2024 revisions to the EU in vitro diagnostic Medical Devices Regulation, the UK MHRA has published a legislation extending acceptance of CE-marked in vitro diagnostic medical devices (IVDs) on the Great Britain (GB) market (Registration of certain in vitro diagnostic devices - GOV.UK).
Commission Implementing Decision on harmonized standards for medical gloves for single use
A European Commission Implementing Decision has amended and expanded Implementing Decision (EU) 2021/1195 as regards harmonized standards for medical gloves for single use, sterilization of medical devices and patient handling equipment used in ambulances. Compliance with this harmonized standard confers a presumption of conformity with the corresponding essential requirements set out in the Medical Device Regulation.