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 …
Medical Devices Directive
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 …
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 …
New Lists of European 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) …