medicines-medical devices-regulatory affairs
Last updated: 3 December 2024 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: 26 November 2024 To view updates, click on the ‘+’ sign below. This post provides information on the ongoing changes to the EU the variation Regulation (EC) No 1234/2008 and guideline. Timeline of events leading to the publishing of…
Last updated: 23 November 2024 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…
This post is an attempt to provide basic information on electronic Product Information (ePI) in the EU What is the definition of Product Information (PI) and which documents does it include? Product information (PI) is defined as documents providing officially…
Last updated: 26 April 2024 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: 18 April 2024 See updates below On 26 April 2023, the European Commission published its pharmaceuticals reform proposal for more accessible, affordable and innovative medicines. This was covered in a previous post. This post is an attempt to…
Last updated: 12 April 2024 See updates at the end of the post The European Commission is proposing to revise the EU’s pharmaceutical legislation – the largest reform in over 20 years in order to make it more agile, flexible, and adapted…
Last updated on 26 October 2024 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: 18 March 2024 See updates at the end of the post. On 27 April 2023, the Commission proposed new rules to help companies, especially small and medium-sized companies (SMEs), make the most of their inventions, leverage new technologies…
Guidance No. About the guidance MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR – December 2023 This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations…