medicines-medical devices-regulatory affairs
Last updated: 16 February 2026 To see updates, click on the ‘+’ sign below. This post is an attempt to outline the timeline of proposed changes to the UK regulatory framework for medical devices, including the transitional arrangements. The regulations…
An application for authorisation of an integral combination product (a medicinal product with an integral medical device component) in the EU must prove that the medical device component meets the general safety and performance requirements (GSPRs) according to Annex I…
Last updated: 20 January 2026 To view updates, click on the ‘+’ sign below: On 16 December 2025, the European Commission proposed a targeted simplification of the current rules for medical devices to make them easier, faster and more effective…
Last updated: 4 December 2025 To view updates, click on the ‘+’ sign below. The Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the…
Last updated on 8 July 2025 See history of updates below. This post is an attempt to provide an information resource for the Medical Devices Regulation (EU) 2017/745 (MDR). The information provided is by no means exhaustive or complete. Although…
Last updated: 27 June 2025 To view updates, click on the ‘+’ sign below. What is COMBINE? COMBINE is one of the initiatives highlighted in the Draghi report to support EU competitiveness in clinical research. When did the COMBINE Project 1 –…
The legal requirements for the maintenance of medical devices are regulated in: Swiss Good Practice for the Maintenance of Medical Devices (GPI) The “Swiss Good Practice for the Maintenance of Medical Devices” (GPI) is a guideline that explains the requirements…
The amended regulation on in-vitro diagnostic medical devices (IvDV) came into force on 1 January 2025. With the entry into force of the amended Ordinance on In Vitro Diagnostics (IVDV) today, Switzerland is implementing the extended transition periods in accordance…
Last updated: 6 August 2024 This post is an attempt to provide basic information about Swissdamed and progress with its availability. To see the updates, click on ‘+’ sign below. About Swissdamed Swissdamed is Swissmedic’s new database for registering economic…
The TGA has published a list of changes to medical device regulations. The table below is an attempt to present the information in a manner such that it can be read easily. Devices or audit application requirements Changes already in…