medicines-medical devices-regulatory affairs
Last updated: 26 October 2025 See history of updates below. The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms is currently in progress. This project will have a wide ranging and positive impact on industry stakeholders…
Date Title of guidance and link to document Type and levelof guidance About the guidance 26 Jun 2025 (Medical Devices) Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Final This guidance is applicable to devices with…
Last updated: 1 July 2025 To view updates, click on the link below: Switzerland is considered a leading research locations for clinical trials. What is at the core of the fast-track procedure? At the core of the fast-track procedure will…
Last updated: 28 June 2025 To see updates, click on the ‘+’ sign below Anyone who has worked on licensing medicinal products in the AsiaPac, LatAm and MEA regions will quite likely have encountered the requirement to obtain a legalised Certificate…
Last updated: 23 June 2025 To view updates, click on the ‘+’ sign below. Report and minutes from the CMDh meeting held on 20-21 May 2025 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of…
Date Guidance No About the guidance 19 Jun 2025 MDCG 2025-6 FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act (June 2025) This document provides a first set of…
Last updated: 20 June 2025 To view updates, click o the ‘+’ sign below. The UK launched the regulatory Innovative Devices Access Pathway (IDAP) in September 2023. About the Innovative Devices Access Pathway (IDAP) The aim of IDAP is to enable and…
Last updated: 11 June 2026 To view updates, click on the ‘+’ sign below. This post is an attempt to provide basic information about patents, Supplementary Protections Certificates (SPCs) and Supplementary Protection Certificate (SPC) manufacturing waivers. The information provided is…
Last updated on 4 June 2026 See history of updates below. This post is an attempt to provide an information resource for the Clinical Trials Regulation (EU) no 536/2014 (CTR). The information provided is by no means exhaustive. Click on…
Last updated: 27 May 2025 To see updates, click on the ‘+’ sign below The EU Innovation Network (EU IN) has launched Phase 2 of the simultaneous national scientific advice (SNSA) pilot. The EU IN started Phase 1 of the pilot for Simultaneous National Scientific…
Last updated: 28 April 2025 To view updates, click on the ‘+’ sign below eAF v1.27.0.1 (Human Variation) now available, for use from 1 May 2025 A new version of the Human Variation eAF v1.27.0.1 is now available on the eAF website.…
Last updated: 10 April 2025 To view updates, click on the ‘+’ sign below: The EU Simultaneous National Scientific Advice (SNSA) pilot has been extended to the end of 2021 due to the COVID-19 pandemic, in order to allow additional…