- Are you developing a new medical device but don’t know how to go about generating a CER?
- Have you got a legacy medical device on the market without a CER, or an older CER that does not meet the regulatory requirements of (MEDDEV 2.7.1 Rev 4) or the new Medical Device Regulation (MDR)?
- Do you want to know how your clinical evidence can be enhanced to improve the probability of commercial adoption to drive future sales?
If the answer to any of these questions is yes, you may benefit from Medilink’s CER strategy service, designed to identify gaps and plan solutions aimed at achieving regulatory compliance.
A Clinical Evaluation Report (CER) (MEDDEV 2.7.1 Rev 4) is required for all medical devices irrespective of their classification.
For companies to maintain the CE mark for existing products and to secure CE marking for new products, it is essential to demonstrate through the CER that the benefits of using the device outweigh any risks.
Without a compliant clinical evaluation report in place you could have your CE mark suspended by the regulator, impacting sales and future revenue.
Medilink’s Innovation and Commercialisation team have been authoring CER’s since 2010 (when CER’s first came into force) and are amongst the most experienced specialists in this field.
For more information and advice on what to do next please contact Patrick Trotter on firstname.lastname@example.org