Factsheet for Class I Medical Devices

What you need to know about Regulation (EU) 2017/745? This factsheet is aimed at manufacturers of Class I medical devices. It covers devices that have already been placed on the market under Directive 93/42/EEC (MDD) and new devices intended to be placed on the market for the first time in accordance with Regulation (EU) 2017/745 of the European Parliament and the Council of 5 April 2017 (MDR).
April 29, 2021

Q&A RELATED TO THE ASSESSMENT OF SIMILARITY FOR ADVANCED THERAPY MEDICINAL PRODUCTS (“ATMPS”) IN THE CONTEXT OF THE ORPHAN LEGISLATION. (updated)

The concept of similarity in an ATMP setting has been updated by European Commission on April 13. The Q&A document has been revised with new questions and examples based on accumulated experience. In particular, these questions have been raised by developers of ATMPs regarding the application of the concept of “similar active substance” in ATMP setting:

  1. What differences in the starting materials may be considered relevant to support a claim of non-similarity?
  2. Can a difference in principal molecular structural features be considered relevant to support a claim of non-similarity?
  3. What level of evidence should be provided to demonstrate that differences in the biological characteristics and/or biological activity are relevant for the intended therapeutic effect and/or safety attributes of the product?

April 29, 2021

EU clinical trial portal and database declared functional

The European Medicines Agency (EMA) announced that the clinical trial EU Portal and Database are fully functional, paving the way for the launch of the EU Clinical Trial Information System (CTIS) and the application of the EU Clinical Trial Regulation by 31 January 2022. (The CTIS was originally expected in September 2018 but a series of delays have pushed back the launch). “The implementation of the Clinical Trial Regulation and CTIS will increase efficiency in the registration, conduct and supervision of clinical trials in the EU, particularly those taking place in multiple Member States, while ensuring utmost transparency for the public. This is one of the most complex and ambitious IT developments carried out by EMA…” said Christa Wirthumer-Hoche, chair of EMA’s Management Board.
April 22, 2021

COMMISSION IMPLEMENTING DECISION (EU) 2021/611

Commission Implementing Decision (EU) 2021/611 of 14 April 2021 amending Implementing Decision (EU) 2020/438 as regards harmonised standards on biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products and clinical investigation of medical devices for human subjects.
April 16, 2021

Nitrosamine Implementation Oversight Group (new)

The Nitrosamine Implementation Oversight Group (NIOG) was set up (in February 2021) by the European medicines regulatory network to oversee the harmonised implementation of the Article 5(3) CHMP opinion on nitrosamines in human medicinal products and to provide progress updates to the European Medicines Regulatory Network Authorities. The Terms of Reference of NIOG, containing scope, membership, oganisational and administrative support, mandate and workplan are now available, click here.
April 14, 2021

How are COVID-19 vaccines made?

Gianni Rezza, General Director of Prevention for the Italian Ministry of Health, explains Covid-19 vaccines: development, evaluation, approval and monitoring. #vaccines #covid19italy
April 12, 2021

Notice concerning regulation 251

Confirmation of the regulation 251 of the Human Medicines Regulation following the Brexit transition. The MHRA announces that the UK remains a member of Council of Europe and the European Pharmacopoeia following the Brexit transition. So, products in the UK are expected to meet the standards published by the Brexit Pharmacopoeia (which are reproduced from the European Pharmacopoeia) after the transition period.
March 31, 2021

Get scientific advice from MHRA

Guidance on getting scientific advice from the MHRA has been updated. It concerns more information on fees, applying for Small and Medium Company status and how this status can be incorporated into the request for scientific advice.
March 30, 2021

Medical Device Coordination Group Document MDCG 2021-3

The Medical Device Coordination Group (MDCG) provides advice to the Commission and assists the Commission and the Member States in ensuring a harmonised implementation of medical devices Regulations (EU) 2017/745 and 2017/746. “Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices” is a high-level document aimed at addressing the most pertinent questions relating to custom-made devices falling under Regulation (EU) 2017/745 on medical devices (MDR).
March 26, 2021