UK Government Brexit Guide Clarifies Rules for Manufacturers
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 …
Han Zuyderwijk
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) …
EN 12312-6 Superseded
On 30 September 2017, the EN 12312-6:2014 + A1:2009 for Aircraft ground support equipment – Specific requirements – Part 6: De-icers and de-icing/anti-icing equipment was supeseded by the version EN …
Household Standards Superseded
Today (September 29, 2017), the following European harmonised standards are superseded: EN 60335-2-23:2003 – Household and similar electrical appliances – Safety – Part 2-23: Particular requirements for appliances for skin …
New Lists of European Harmonised Standards Published
On the September 8, 2017, the European Commission published a new list of European harmonised standards for the following directives: the Low Voltage Directive (2014/35/EU) the ATEX Directive (2014/34/EU) If …
EU Recalls 6 Chinese Wall Chargers Over Electric Shock Risks
The European Commission (EC) ordered a recall of six Chinese wall chargers over electric shock risks earlier this month, as revealed by the 29th report released this year as part …