Tips for Updating Clinical Evaluation Reports (CER) and MEDDEV 2.7/1 rev 4

June 25, 2018

Clinical Evaluation ReportAs many veteran QA/RA professionals are painfully aware, the days of a 10-page Clinical Evaluation Report (CER) are a blissful memory of a bygone era. Today’s medical device CERs are now substantial in content, dynamic through the entire life cycle of a product, and essential for maintaining certification in the EU and other markets.

The CER is intertwined with the larger assortment of technical documentation that includes your risk management file and postmarket surveillance data. Countries such as China and Australia are increasingly scrutinizing CERs and expecting them to be far more integrated into your overall regulatory processes.

The new EU Medical Device Regulation (2017/745) requires that risk management and clinical evaluation merge to form interdependent and aligned processes, and it places much higher scrutiny on ensuring there is sufficient clinical evidence to support general safety and performance requirements for a medical device.

The increased focus on risk reduction is, in part, a reaction to the PIP scandal in 2010. 

Does your CER need some TLC ASAP?

Originally published in 1993, the Medical Devices Directive (93/42/EEC), or MDD, did not explicitly require clinical data for low-risk devices. A revision in 2007 patched this hole, saying clinical evaluation was required for all devices. The releases of the EU MDR in 2017 and MEDDEV 2.7/1 rev 4 in 2016 tightened the requirements even more and have many companies scrambling to meet the new clinical data expectations before their next Notified Body audit. The end goals of the CER, risk management, and postmarket surveillance (PMS) are, of course, to reduce device risk, make sure the device performs as intended, and reduce side effects to be as few and nonhazardous as possible.

Many medical device manufacturers – especially those with numerous low-risk devices – have not updated their CERs in many years. (Some companies cannot even find some of their CERs due to mergers and acquisitions.) That can create big problems, because today’s CER is not expected to sit ignored on someone’s virtual bookshelf year after year. It’s a living, breathing document, and Notified Bodies expect you to periodically add new data from clinical literature searches, postmarket feedback, published regulator databases, in-house private clinical reports/data, and publicly available clinical trial data. Clause 6.2.3 of MEDDEV 2.7/1 rev 4 requires that the CERs for high-risk devices be updated at least annually. For established low-risk devices, updating the CERs every 2-5 years might be acceptable. Regardless of classification, you need to define and justify the update frequency of your device. 

Tips on creating and updating your medical device Clinical Evaluation Reports

If you have many Clinical Evaluation Reports to update or are getting started on a new one, figuring out where to start can be mind-numbing. Here are some tips to help ease your pain.

1 – Establish a literature search strategy to avoid driving yourself crazy.

Literature searches are the bane of RA professionals everywhere, and they will drive you nuts too if you don’t have a protocol established for conducting them. Searches often start on PUBMED and extend to EMBASE, Cochrane, or Google Scholar. Regardless of the sources you use, it’s important to define search terms in advance and determine how you will filter the resulting tsunami of search results. PUBMED alone has 28 million citations, so you really need to think carefully about how you search to avoid missing relevant results.

We recommend spending some time reading the FAQs on PUBMED, as they will give you more information on how to plan your attack. Also, watch this great 2-minute YouTube video tutorial on PUBMED use. One final tip: You can save search criteria in PUBMED and receive automated emails when new results match your criteria. Hooray for automation!

2 – Don’t cherry pick results – include the good, the bad, and the ugly.

We all love good news and it’s tempting to show only data that presents your device in a flattering light. However, it is vital that you include all relevant information you find, even if it’s not wholly positive. The entire point of doing a periodic CER review is to see if information has emerged that changes your assessment of device safety and effectiveness. Also, keep in mind when you conduct an update that the term “equivalence” is more narrowly defined in MEDDEV 2.7/1 rev 4. For example, if you previously leveraged clinical data from a competitive device with the same clinical, technological, and apparent biological characteristics but that device in actuality uses different materials, its clinical data may no longer be acceptable. Check your existing data to make sure any competitive products meet the new definition of “equivalent.”

3 – As part of clinical evaluation planning, create a review schedule for your CER and add new data as you find it.

Establishing a clinical evaluation plan according to the MEDDEV and new regulations is essential to managing the overall process of clinical evaluation.  Creating a fixed review schedule as part of planning and review for each device is the best way to ensure that your Clinical Evaluation Reports don’t go stale. Your review frequency should be documented, and you can use various online tools (such as Microsoft Outlook) to remind you when reviews must occur. However, creating a schedule does not mean you should perform updates only at those intervals – if you receive new clinical data or data from postmarket surveillance activities that could change your existing evaluation, you should update it. Also, new technology might not have a large body of clinical or PMS data initially, so your update schedule might need to be more frequent than the schedule of a device that has been on the market a long time.

4 – If you outsource CER writing or updates, don’t let perfect be the enemy of the good.

With the EU MDR enforcement coming in May 2021, regulatory professionals have their hands full. Companies with large device portfolios may find it more efficient to outsource CER updates and literature reviews. The problem is that many of the best people with experience in Clinical Evaluation Reports have been swallowed up by companies and Notified Bodies. Still, if you choose to outsource, you will want to look for someone who has a lot of experience writing scientific, technical, and medical content, as well as experience writing CERs. Ideally, that same person will have device knowledge, preferably in your specific therapeutic area. As if those qualifications were not already challenging enough, make sure you work with someone who knows MEDDEV 2.7/1 rev 4. There are a lot of pharma writers with clinical data writing experience, but they may not have a clue about this MEDDEV. That being said, finding someone who meets all criteria is rare indeed, as such people are generally employed full time. So, with a full realization that you might not get everything you want, choose the skillset that’s most important to you and get started. Finding high-quality people with CER expertise will only get harder in the next few years.

5 – Make sure your CER is fully integrated with risk management, PMS, and vigilance.

Finally, if you have been working in regulatory compliance for several years, you will remember a time when the CER, risk management, and PMS were all in silos. No more. The EU MDR, MEDDEV 2.7/1 rev 4, and EN ISO 14971:2019 all make it very clear that clinical data, risk management, and PMS processes need to be fully integrated. The blurring of lines also becomes evident for companies choosing to participate in the Medical Device Single Audit Program (MDSAP), which continues pushing the process approach throughout the entire quality management system, not just individual regulatory items.

As the compliance deadline for the EU Medical Device Regulation draws closer and certificates for existing devices near their expiration, companies will need to dedicate more time to updating CERs well in advance of Notified Body audits. Auditors will be looking at your Clinical Evaluation Reports through a different lens than they have in the past. Consider our training class on CERs, or let us assist you in writing new CERs or updating existing ones.

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