Services: Medical Devices & In-Vitro Diagnostics
GRS has several specialist medical device teams and individuals who can support and guide you through the appropriate regulatory pathways to market no matter where your company is located or in which territory you wish to launch. America and Europe are popular destinations but increasingly we are assisting companies to launch into Rest-of-World.
The global Medical Device Industry is undergoing significant change not only because of advances in science and technology but also because of increasing and more stringent regulations. In Europe, for example, two new regulations coming into law during early 2017 are to replace the current three directives:
- The Medical Device Regulation (MDR) will replace the Medical Device Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMD) 90/385/EEC, and
- The In-Vitro Diagnostic Regulation (IVDR) will replace IVD Directive (VDD) 98/79/EC.
There is a three year transition period for medical device manufacturers and a five year transition period for in-vitro diagnostic manufacturers to achieve full compliance with these new regulations.
The new regulatory framework is going to be much tougher than before with some devices having to go through a pre-market assessment process by the European Medicines Agency (EMA) and manufacturers (and their supply chain) will be subjected to mandatory unannounced audit visits by the Notified Bodies. There are also reinforced rules for clinical investigations and clinical evaluations (a new concept in IVD legislation).
GRS is closely monitoring these changes and already, we are conducting many portfolio assessments to ascertain the impact of these new regulations and designing implementation plans to ensure our clients achieve compliance during their respective transition periods.
Please contact us if you’d like the experienced GRS Team to help you plan your Medical Device/IVD strategy to maintain your presence in this rapidly growing market.
