medicines-medical devices-regulatory affairs
Last updated: 14 July 2025 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: 10 July 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…
Last updated on 9 July 2025 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 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: 15 July 2025 To view updates, click on the ‘+’ below. The Government announced in its Regulatory Action Plan on the 17 March 2025 that the AI Airlock will run another phase during the 2025-2026 financial year. Applicants…
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: 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 –…
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…