Today is a significant day, as today, May 26 2021, is the date of applicability (DoA) of the European Medical Device Regulation (MDR, also known as 2017/745). While that is a major milestone, I doubt whether champaign corks were heard popping at medical device companies, Notified Bodies, or the European Commission. It has been a …
In February the Department of Human Health & Services and the FDA lost a lawsuit regarding missing clinical trial data in the ClinicalTrials.gov repository, which I wrote about here. Prior to the judges’ decision, despite the transparency requirements, FDA has never imposed a fine on a clinical trial’s sponsor, and the National Institutes of Health …
The Medical Device Coordination Group just released a guidance document on Notified Body audits during the ongoing COVID-19 pandemic. It takes immediate effect and is valid for the period of the duration of the pandemic as declared by the WHO. It covers alternative solutions to carrying out on-site audits by notified bodies under the medical …
The amended MDR (2017/745, amended by 2020/561) has been made available on the EU website here. If you haven’t been keeping up, the main change is that it moves the Date of Application of the MDR back one year, from May 26th 2020 to May 26th 2021. I have covered it more in depth in …
Last week the European Parliament overwhelmingly voted in favor of the Commission proposal to amend the MDR. Even though this was just a vote in the first reading, it is now almost a certainty that the Date of Application of the MDR will be moved to May 26th 2021, as the Council has already confirmed …
MDR Date of Application move now almost a certainty Read More »
The MDCG has finally published it guidance MDCG 2020-2, which covers transitional provisions under article 120 of the MDR. It sets out important procedural requirements for a class I manufacturer about how to document things, what the state of the technical file and QMS should be and what the declaration of conformity should look like, …
New Class I Article 120 (3) and (4) guidance released Read More »
For over 10 years, mandatory reporting of clinical trial results to ClinicalTrials.gov had been part of Federal law. However, the FDA has never taken any enforcing action against parties not abiding to this requirement. Unsurprisingly, a piece of law that is not enforced is often ignored. Now plaintiffs Peter Lurie, a former associate FDA commissioner …
Federal judge rules clinical trial sponsors must publish 10 years worth of missing data Read More »
On 6 January, the Medical Device Coordination Group (a European Commission’s Expert Group) released a long-awaited guidance on cybersecurity for medical devices. The document is based on IMDRF work on cybersecurity for medical devices, to which it often refers, specifically the very useful IMDRF’s Principles and Practices for Medical Device Cybersecurity document, which is currently under …
Cybersecurity for medical devices: Official EU guidance released Read More »
