medicines-medical devices-regulatory affairs
Last updated: 11 November 2026 TO view updates, click on the ‘+’ sign below. Harmonised standards – Medical Devices Harmonised standards under the Regulations on medical devices and in vitro diagnostic medical devices are developed by CEN and CENELEC as European…
This post covers international regulatory news in brief. It is updated on an ad hoc basis. For ease of navigation, a tab has been added for each region/topic (below). Each tab includes the date for most recent update under that particular tab.…
Last updated: 9 November 2026 To view updates, click on the ‘+’ sign below: On 30 January 2025, the new ILAP was launched by the following: Below is an attempt to lay out the guidance in an easy to understand…
Last updated: 9 November 2026 The UK MHRA has published guidance on the International Recognition Procedure which became operational on 1 January 2024. This post is an attempt to present the information in a Q&A format. The information is by…
Last updated: 10 November 2026 To view updates, click on the ‘+’ below. AI Airlock Background The AI Airlock was established to proactively investigate the regulatory challenges of AI as a Medical Device. Working with key partners during the pilot…
Last updated: 6 November 2026 This post is an attempt to provide basic information on Health Technology, its assessment and the new Regulation (EU) 2021 Click on the ‘+’ sign next to each heading to access the information under each…
Last updated: 6 November 2026 Below is an attempt to provide information on the new clinical trials regulations. The information is by no means complete or exhaustive. Please use this post as a starting point and take the time to…
Last updated: 4 November 2026 For updates, click on the ‘+’ sign below. This post aims to provide basic information on the FAST-EU initiative. The information is by no means exhaustive. What is the FAST-Initiative? FAST-EU (Facilitating and Accelerating Strategic…
Last updated: 4 November 2026 To view updates, click on the ‘+’ sign below. For a basic introduction to IDMP, watch this clip from the Uppsala Monitoring Centre, Sweden. Some more information is available in this blog post. The EU…
Last updated: 4 November 2026 To view updates, click on the ‘+’ sign below. Below is an attempt to provide information with the intention of facilitating a better understanding of the progress with the update to the EU pharmaceutical legislation.…
Date Guidance No About the guidance 3 Nov 2026 MDCG 2026-6 Clinical evidence for orphan in vitro diagnosticmedical devices This document provides guidance to manufacturers, notified bodies, expert panels, health institutions,and regulators on the clinical evidence requirements for orphan IVDs…
You can listen to available guidance podcasts at this link. Date Title of guidance and link to document Type and levelof guidance About the guidance 30 Oct 2026 E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and…