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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. 

ISO 13485 Colour UKAS (New)

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

Certificate of Registration     

Declaration of Conformity Documents

UKCA DoC - Compression Garments for Therapy Management

UKCA DoC - Lymphoedema

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 - Lymphoedema

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®