Following the UK’s departure from the EU, we have taken appropriate measures to ensure the safeguarding of our CE Mark on all our CE medical devices through the appointment of a European Authorised Representative. This means that we will remain able to compliantly supply to the EU in the event of the Brexit transition phase ending without a mutual recognition deal for medical devices. Our NEW registration document complies with the requirements of the medical device Directive 93/42/EEC as amended by 2007/47/EC. We hold the quality management system certified ISO13485:2016 (01-0083-1-MED).
All Jobskin products have been granted CE certification as Class 1 Medical devices.