Medical devices and in vitro diagnostic tests must have a CE Mark before you can place them on the European (including UK) market. This includes digital health products and Apps, if they meet the definitions in the regulations.
We are experts in regulatory compliance of these types of products with the Medical Devices and in vitro Diagnostics Directives 93/42/EC and 98/79/EC. We have an in-depth knowledge of the Medical Device and in vitro Diagnostics Regulations which came into force in May 2017
- Advise on classification, conformity assessment routes and prepare technical files.
- With associates, prepare and implement the Quality Management Systems required to comply with the Medical Device Directive 93/42/EC.
- Undertake a gap analysis and plan for your transition to the Medical Device Regulations EU 2017/745
- Act as your Retained Counsel on quality assurance and regulatory affairs,to meet your post-market obligations
- Prepare regulatory requirements to support grant funding bids
So, if you are unclear about your regulatory obligations, why not drop us a line for a free consultation.
Full details on our Contact page