Services backed by a responsive, multilingual team of regulatory experts that are there when you need them
The requirement of a European Legal Representative (LR) for clinical investigations is seen in DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of Good Clinical Practices in the conduct of clinical trials on medicinal products for human use.
Whilst this directive is regarding medicines, it has been transposed into local law regarding medical devices in many European countries. These laws have recently come to the forefront and are being enforced across Europe.
The responsibilities associated with the role as European Legal Representative (LR) vary, with the greatest responsibility being complete liability.
MedPass Limited provides a full European Legal Representative (LR) service which offers the following advantages:
– Immediate access to the entire resource of an established CRO with extensive expertise in regulatory affairs, clinical research and market access for medical devices in Europe;
– A multilingual company with a presence all across European countries and at the leading of the most recent regulatory changes and evolutions;
– A fully integrated service whereby Legal Representative (LR) status is seen as a central component of the overall service offered to clients seeking comprehensive expert assistance throughout the product lifespan
Windsor House, Bretforton, Evesham, Worcestershire.,
WR11 7JJ, United Kingdom