CE Marking of face masks and PPE: What importers need to know

What do importers of face masks, gowns, gloves and other personal protective equipment need to know about CE marking? The Z-files podcast has published the interview they did with me that covers this topic in depth. Except for the Corona-hairstyle, which the video editor was unable to fix, I am pleased with the very informative … Read more

UK Government Brexit Report Provide Guidance on Medical Devices

On 8 October the UK Government issued its “No Deal Readiness Report”. Whilst it is not yet known whether the UK will leave with or without a Withdrawal Agreement at the end of October, the report sets out guidance for industry across a range of sectors – including providers of medicines and medical devices. Guidance … Read more

European Commission Publishes Updated Borderline & Classification Manual

On October 30, 2018 the European Commission published a new version of the Borderline & Classification Manual. This manual is intended to provide guidance on the status of medical devices and in vitro diagnostics and their risk classifications. The manual adds six new items: two to help determine medical intended purpose, one for classification and … Read more

New Lists of European Harmonised Standards

List of harmonised standards

Today, the European Commission has published new lists of European harmonised standards for the following Directives: Pressure Equipment Directive (2014/68/EU) Active Implantable Medical Devices Directive (90/385/EC) Medical Devices Directive (93/42/EC) In Vitro Diagnostics Directive (98/79/EC) Radio and Telecommunication Terminal Directive (1999/5/EC) and Radio Equipment Directive (2014/53/EU) The PDF documents with the new lists of standards … Read more