Jobskin | Reaching for the best solution

  • Currency
    £
  • Language
    EN
Basket

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).

All Jobskin® products are CE marked as class 1 medical devices

CertificateCertificate of Registration

Declaration of Conformity Documents

DoC - Declaration of Conformity - Scar Management

DoC - Declaration of Conformity - Lymphoedema 

DoC - Declaration of Conformity - Compression Therapy for liposuction

DoC - Declaration of Conformity - SDO Sensory Dynamic Orthosis

DoC - Declaration of Conformity - Corsets MTM & RTW Orthoses

DoC - Declaration of Conformity - Orthowrap Orthoses

DoC - Declaration of Conformity - ScarSil®

DoC - Declaration of Conformity - ScarFX®