Implications of revisions 4 of MEDDEV 2.7.1 and CER for medical devices.
In this blog Pepgra CRO experts clear the air on both the above topics. We also discuss the following:
- CER—what does it entail?
- CER—who should submit?
- CER—How is it stated in the new revisions?
Your CER must comply with Meddev 2.7.1 rev 4/MRD 2017/745 if you want to market your device in EU; the report documents the findings of evaluation of that specific device. To ascertain device safety and function, perform an evaluation of the clinical data; This is exactly what a clinical assessment is all about.
Toward this objective, a clinical assessment helps you in achieving a CE mark; there are many instances where device makers fall short of the EU requirements and standards and this is exactly where Pepgra CRO experts can assist you in getting compliance and the necessary approval documentation. Our CRO professionals have the expertise and proficiency when it comes to all aspects of EU regulatory approval process; therefore, prepare for 100% compliance thanks to professional support.
Safety and risk mitigation play an important part because if your device is CER compliant then it means you have the clinical evidence/data to support your claim that the device achieves its intended objective. Trial results, literature study, and experience are other factors that attribute to a CER compliant device
Ensure you aim toward completing and achieving CER as a single file; ensure you prepare and deliver the CE report with the technical file because the CE assessment process involves both.
CER life cycle and need to update
The question is when to update the device CER. The answer is “regularly” based on the proceeding Vigil operations, PMS, and clinical assessments. Ensure you do it on a yearly basis or if you get new updates from PMS that could affect the clinical assessment; you can also do it every two to five years considering the fact that the medical device does not have major risks associated with it and it is well set in the market.
So how Pepgra experts can help you?
Pepgra can support you in report writing and literature study; we focus on studying data from device and guide you through the cumbersome EU regulatory process and our regulatory affairs professions are hands-on when it comes to various types of devices, versions, and IVDs. Talking about specifics, Pepgra will
- Garner relevant articles pertaining to your device from literature study;
- Draft CER in light of stringent EU regulatory mandates;
- Perform CER compilation and do further literature study for CER updation;
- Design protocols for systematic search; and last but not the least,
- Do journal evaluation and synopsis preparation.
Also, when it comes to the revisions 4 of Medev, talk to us today to ensure you meet the new guidelines. Here are the frequent questions we get from clients:
1. Do device makers—small, simple, and safe devices meet the guidelines if the device does not need clinical evaluation or lacks relevant literature pertaining to that device?
If the device is on the market, Post-market surveillance data should be available to support it; Be clear about the safety and performance that can only be addressed by clinical data and focus the CER on that data. A good review of the state-of-the art will also set the relative risks and benefits in context, as well as identify any standardization of the design that may help identify equivalent devices. However, even for lower classification devices, it may be necessary to conduct a clinical study if clinical data is not available in the published literature, or if the device has a novel feature
2. Do I need to display the equivalence for those currently available in the market?
This hinges on whether you are depending on clinical data that was generated on equivalent devices; Requirements for equivalence in Medev revision 4 must be complied, even if the device is already CE marked. Yes, CER is indeed a continual process. You may also replace the original clinical data on equivalent devices with PMS data gathered on the device itself.
3. Will the CER requirements be affected by recent EU regulations—MDR 2017/745?
MDR 2017/745 and CER guidance MEDDEV 2.7/1 rev 4 were updated; Both documents reveal more strict requirements for clinical data and there will be a 3 year migration phase to the MDR, which becomes applicable in middle of 2020.
To know more about CER requirements or the MDR, contact Pepgra CRO experts.
Pepgra is a leading CRO solutions for medical device manufacturers with offices across US, UK and India. Pepgra CRO experts offer assistance in all phases of clinical trials. Clinical research, regulatory affairs, regulatory writing, medical writing, Clinical Trial Protocols (CTP), biostatistical programming, trial patient monitoring, and Post-marketing Surveillance (PMS)—these are some of our offerings with niche therapeutic offerings as a key differentiating factor. Partner with Pepgra today; your reliable CRO partner. www.pepgra.com | +1-972-502-9262 | sales@pepgra.com
