All medical devices need to comply with the new Medical Device Regulations (Medical Devices 2017/745 and In Vitro Diagnostics 2017/746) and carry a CE mark in order to be placed in the market in the UK and across the EU. CHEATA can provide advice and support for regulatory compliance where the level of support can depend on the existing expertise within the company and the amount of technical support required.

This can involve a relatively small amount of work from CHEATA e.g. classification review, gap analysis against the Essential Requirements and review of existing documents and processes, though to more extensive support in producing documentation and managing the CE mark process with your Notified Body. We can also ensure that your clinical investigation or performance study includes the right end points to meet your CE mark requirements.

Please note, that we cannot support the CE marking of software or apps as this is outside our area of expertise. 

Read more about how we helped the following companies with their regulatory compliance, with varying levels of input from an initial review for a prototype product for Smartlife, to a short gap analysis for  Platelet Solutions Ltd, through to a more hands-on role including advice on their MHRA submission for a clinical investigation for Surepulse Medical Ltd