Here at Medilink North of England, we are often asked by our clients:
”What’s the biggest cause of delay and failure when obtaining regulatory approvals for a new medical device in Europe? Is it issues with technical documentation, perhaps? Device labelling and IFU? Post Market Surveillance?”
The answer is having the right clinical evidence in the right format within the technical file. More specifically, this means presenting sufficient clinical evidence to support the indications and claims you are making, and that the benefits outweigh any risks. This document is the Clinical Evaluation Report (CER).
Your CER is much more than just a comprehensive list of your clinical evidence. It is a substantial document that requires regular updating according to device classification and accompanies your product throughout its lifecycle. It must be aligned with all of your marketing, product literature and even product website.
It’s not only for products in the EU, either. Other markets are increasingly requiring more thorough documents compiling clinical evidence (e.g. US, China and Australia), showing the direction of travel. It is therefore a useful exercise for companies developing products for other markets.
With the introduction of the EU Medical Device Regulation (MDR), the threshold for quality had been raised further still, creating an issue for many companies on tight budgets and with limited experience of compiling regulatory documentation.
Tom Wright, Innovation and Commercialisation Manager shares his advice on some general principles to follow when approaching the Clinical Evaluation Report:
Author’s qualifications and experience – the author of the CER must have a higher degree in a relevant field and 5 years’ experience or 10 years professional experience if a degree is not considered a prerequisite for the task. This may be a key consideration in the decision whether to use an internal author or whether to outsource
Carry out a proper literature search – as well as internally commissioned trials, evidence can be found in a number of places. Make sure you are searching more than one database to avoid missing crucial data published by third parties. Do not ignore unfavourable evidence either – regulators will pick up on anything you haven’t addressed and mitigated.
Structure the report – having a clear style and an easily navigable report structure will help your auditors quickly hone in on the important parts and give confidence that you have done a thorough job.
Link it to post market surveillance and sales data – as well as traditional clinical study data, you should also use your post market surveillance and sales data to demonstrate safety and strengthen your arguments.
Ensure future post market clinical follow up (PMCF) studies address gaps – data collection beyond the point of regulatory approval is important in further strengthening the evidence base for the product and improving chance of adoption. PMCF studies should be designed to gather evidence you do not currently possess and can be determined by existing gaps highlighted via the CER.
…but if you want to remove as much risk as possible…
Outsource to specialist author - writing a CER is a substantial undertaking. It can take an enormous amount of internal resource to create and needs regular updating. Finding an experienced author will increase your chances of ‘getting it right first time’ and getting your product on the market at first attempt.
Medilink North of England (an independent and not for profit organisation)is a specialist innovation and commercialisation consultancy in the medical technologies field and is a highly experienced author of CERs to MEDDEV/2.7.1. Rev4 standard. Member of the team have been writing and assisting with CERs for both SMEs and multinationals since 2010. Medilink North of England have a proven track record of quality, receiving excellent feedback from the notified bodies, and have experience in assisting companies to maximise the value of their existing clinical evidence and obtaining and maintaining regulatory approval.
Remember: regulatory approvals don’t need to be an emergency!
For a no obligation chat about your CER needs, please call 0114 232 9275 or contact us on firstname.lastname@example.org to discuss your requirements.