Regulation Gap Analysis
Regulation transition MDD/IVDD or MDR/IVDR
If a manufacturer has been supplying Medical Devices, or In-Vitro Medical Devices, into the European Union for several years now they will have been conforming to the original Medical Device Directive (MDD), or the In-Vitro Medical Devices Directive (IVDD).
In 2018 the new European Union regulations (MDR and IVDR) will start to come into force and it is important for manufacturers to have a detailed review of their technical documentation (Technical Files), and CE certification status, to assure they still are able to claim to meet the latest CE marking requirements.
The normal approach for this will be to undertake a gap analysis of their original technical documentation (Technical Files) so they understand the changes that will be or may be necessary.
Such a gap analysis may also be applicable for the quality management system (QMS) as there is a strong link between quality management and the new regulations.
Advena are able to undertake such gap analyses in an expert and cost-effective manner to assure manufacturers do not start making changes that are not necessary or not appropriate.