Blog Medizinprodukte

European Commission updates list of harmonised standards in Official Journal

EU MDCG endorses guidance document

Standards are used to support the regulatory process because they are developed in accordance with set principles of transparency, openness to participation by interested stakeholders, balance of representation and due process.

It’s critical that medical electrical equipment performs as intended and safely. To these ends, we’ve amended one of the core European standards in this area. This blog post explains what the standard covers and what’s been changed by the amendments.

It’s fair to say that the British Standard specifying laboratory autoclaves was overdue for a revision, having been reviewed regularly but not changed since 1993. This blog post discusses the big changes that have now taken place.

In relation to international travel into the UK, how does Test to Release and the new Day 2 & Day 8 international arrival testing work, and what part do two international standards play in the Government’s scheme? This blog post sets out the details.  

The international safety standard on the biological evaluation of medical devices within a risk management process has undergone a lengthy and comprehensive revision. This blog post discusses the results.

A newly revised British Standard describes how to perform microbial barrier testing using the methylene blue particulate penetration method. This blog post explains why the standard has been updated and why it should be used by medical device manufacturers.