Update to the Borderline Manual provides both guidance on product classification and insight into the Working Group thought process.
Medical Devices, Borderline Manual Elisabethann Wright Medical Devices, Borderline Manual Elisabethann Wright

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

Read More
UK Regulations Governing Post-Market Surveillance of Medical Devices Enter Into Force
Medical Devices, Post-Market Surveillance, MHRA, In Vitro Diagnostic, Implantable Medical Devices Elisabethann Wright Medical Devices, Post-Market Surveillance, MHRA, In Vitro Diagnostic, Implantable Medical Devices Elisabethann Wright

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.

Read More
Revised Regulation on Instructions for Use in Electronic Form Expands Its Scope of Existing Provisions
Medical Devices, Instructions for Use Elisabethann Wright Medical Devices, Instructions for Use Elisabethann Wright

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.

Read More
Commission Implementing Decision on harmonized standards for medical gloves for single use
Medical Devices, Single Use Elisabethann Wright Medical Devices, Single Use Elisabethann Wright

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.

Read More
The European Court of Justice clarifies different definitions of a medicinal product and a medical device
European Court of Justice, Medicinal Products, Medical Devices Elisabethann Wright European Court of Justice, Medicinal Products, Medical Devices Elisabethann Wright

The European Court of Justice clarifies different definitions of a medicinal product and a medical device

In a recent judgment in response to a request for a preliminary ruling (CURIA - List of results) the European Court of Justice (ECJ) provided guidance concerning how to distinguish medicinal products from medical devices.

Read More
Certain EU medical device laws will not be sunsetted in Great Britain on 26th May 2025
Medical Devices, Great Britain Elisabethann Wright Medical Devices, Great Britain Elisabethann Wright

Certain EU medical device laws will not be sunsetted in Great Britain on 26th May 2025

The plan to sunset a number of EU medical device laws in Great Britain has been revised following related consultation. It had been expected that four pieces of EU legislation; European Commission Decision 2002/364, on common technical specifications for in vitro diagnostic medical devices, Regulation 207/2012, on electronic instructions for use of medical devices.

Read More
Pilot system for sponsors of clinical investigations of medical devices
Medical Devices, Clinical Investigations Elisabethann Wright Medical Devices, Clinical Investigations Elisabethann Wright

Pilot system for sponsors of clinical investigations of medical devices

Sponsors of clinical investigations in the EU have been invited to apply to participate in a pilot scheme introducing a coordinated assessment of clinical investigations and performance studies as provided in Articles 78 of the Medical device Regulation and Article 74 of the in vitro diagnostic medical devices Regulation (https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en).

Read More