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.
- 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.
- 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 e.g. EPSRC.
We have an in-depth knowledge of the Medical Device and in vitro Diagnostics Regulations which came into force in May 2017.
We can help you plan for transition to these Regulations
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