Ramya Sriram, digital content manager at Kolabtree, shares her advice on how medical device companies can improve their clinical evaluation report writing, to help achieve the vital CE mark.
A clinical evaluation report (CER) is an important technical document required for a medical device to be CE marked and therefore sold in Europe. Under the new EU Medical Device Regulations (MDR), which come into place in May 2020, the emphasis on CERs has greatly increased.
Medical device companies without experience in the new process may therefore find CER writing a challenging process.
All medical devices already on the market require recertification, making preparation for the MDR a big task. It involves evaluating your product to check for compliance, while gathering all the relevant technical documentation needed for the technical file. The CER is a vital part of a medical device’s technical file, and CERs must be approached carefully if a product is to be approved.
Familiarise yourself
Firstly, familiarise yourself with the new regulations. You may want to attend conferences to help stay up to date with the changing regulatory landscape. You’re not too late because before the May 2020 deadline there are several events that will take place across the UK. This includes Future Health 2020, held March 17-18 in London, Med-Tech Innovation Expo, hosted April 1-2 in Birmingham and Drug/Device and Device/Drug Combinations in the EU and USA, happening on April 2-3 in London.
You can also access trusted resources to help you brush up your knowledge. For example, the European Commission has shared a guide to the new regulations and the EU has released one for CE marking. For those in the UK, the British Standards Industry offers guidance on what has changed under the MDR and how best to prepare. Kolabtree has produced a series of blog posts, as well as a whitepaper, which can be accessed for free.
Be strategic
Producing a CER is a complex and ongoing process ― complying with the MDR on this aspect is not quite as simple as just updating your previous document. For example, the emphasis on clinical investigations has increased, as have the criteria for establishing equivalence and many devices have been reclassified. You will need to establish across your portfolio of medical devices, whether they conform to the new specifications, and then produce the corresponding CER report.
Because CERs are an ongoing process, you will need a strategy for including post market surveillance and update the CER as required. A structured, coordinated approach across the whole organisation is the most effective way to meet the requirements of the MDR.
Hire a specialist
The changes required by the MDR are extensive, so it is understandable if you do not have an in-house CER expert. Luckily, there are freelance clinical evaluation report writers available to help you. Before hiring, check they have the relevant skills and experience ― an established CER writer would be familiar with the scientific literature, the regulatory documents recommended earlier and they will have been to regulatory conferences and meetings.
The more regulatory challenges the freelancer has dealt with in the past, the better. The ideal scenario is to have the experienced clinical evaluation report writer guide your quality control team through the entire process, in an efficient manner.