UK MDR 2002
Medical Devices Regulation 2002 applicable to the UK market is closely aligned with EU directives, yet the requirements have some unique distinctions. When targeting the UK market specifically, we provide guidance for general medical devices and offer support in meeting the UKCA mark requirements.
GAP ASSESSMENTS FOR UK MDR 2002
Examine your technical file and conduct a gap analysis in comparison to the regulatory requirements.
UK MDR 2002 DOCUMENTATION
Assist in preparing regulatory documentation specific to UK MDR 2002 including declaration of conformity, essential requirements, post market surveillance.
LABELLING REVIEWS
We will evaluate your device labelling to ensure compliance with UK requirements and MHRA designated standards.
SERVICES & EXPERIENCE
QUALITY MANAGEMENT SERVICES
OUR EXPERIENCE
(EU) MDR 2017/745
