The Medical Device Directives are undergoing a major revamp and will be issued as Regulations. The Medical Device Directive, 93/42/EEC and the Active Implantable Directive 90/385/EEC will both be incorporated into a single Regulation, whilst the In Vitro Diagnostic Directive, 98/79/EC will be governed by a separate Regulation.
Unlike Directives, Regulations are not transposed into the national laws of each member state of Europe and are accepted as law as written. This will go a long way towards ensuring that the differences in the interpretation of the Medical Device Directives which currently exist, between different member states, will no longer occur. There are many changes within the current proposal for the new Medical Device Regulations; the scope of the Regulation, the approach to clinical investigations, the role of the Notified Bodies and Competent Authorities, the requirements for vigilance and market surveillance and a scrutiny procedure to name but a few.
NAMSA regulatory expert, Kath Clarke, will be speaking on these new revisions at MedTec Europe. If you would like to set up an appointment with her, please reach out to us at namsa.com/contact-us.
If you would like any more information on these new revisions and what you need to do, please contact us to talk to any of our authorities on this topic as well as other regulatory issues.