MDR Regulatory and Compliance
Quality Assurance
Following the UK’s departure from the EU, we have taken appropriate measures to ensure the safeguarding of our CE Marking on all our CE marked medical devices through the appointment of a European Authorised Representative. We have also completed the full transition of all of our CE marked medical devices to the new EU medical device regulations (MDR, Regulation (EU) 2017/745) which became mandatory in May 2021. This all means that we remain able to compliantly supply to the EU.
We hold the quality management system certified to ISO 13485:2016 (01-0083-1-MED).
A Copy of our Quality Policy is available upon request.
All Jobskin® products are CE marked as class 1 medical devices
Declaration of Conformity Documents
UKCA DoC - Compression Garments for Therapy Management
UKCA DoC - Compression Therapy for Liposuction
UKCA DoC - SDO Sensory Dynamic Orthosis
UKCA DoC - Corsets & Gaiters MTM & RTW Orthoses
UKCA DoC - Orthowrap MTM and RTW Orthosis
EU CE DoC - Compression Garments for Therapy Management
EU CE DoC - Compression Therapy for liposuction
EU CE DoC - SDO Sensory Dynamic Orthosis
EU CE DoC - Corsets & Gaiters MTM & RTW Orthoses
EU CE DoC - Orthowrap Orthoses
DoC - Declaration of Conformity - ScarSil®
DoC - Declaration of Conformity - ScarFX®