Before launching your medical device onto the European market, it is essential to make sure that it fully complies with MEDDEV 2.7.1 Rev 4 and the new Medical Device Regulation (MDR). To achieve this, you need a Clinical Evaluation Report (CER) which would present sufficient clinical evidence to support the indications and claims you are making.
Producing a CER is a key part in maintaining the CE mark for existing products and in securing CE marking for new products. Your CER should also demonstrate that the benefits of using the device outweigh any potential risks. Writing a CER is a substantial undertaking - it can take an enormous amount of internal resources to create and needs regular updating.
As experienced authors of CERs for Class I, IIa, IIb and III medical devices, Medilink’s Innovation and Commercialisation experts can advise you on how to address gaps in your evidence and ensure continued compliance with the legislation. Our team will also help you increase your chances of launching your product onto the market at first attempt.
Enhancing your CER could effectively improve the profitability of commercial adoption to drive future sales. For the opportunity to discuss your clinical evaluation report and receive professional guidance, contact the Medilink Innovation and Commercialisation team today on 0114 232 9275.