Following the release of MEDDEV 2.7/1 Rev 4 with updated guidance on clinical evaluations in Europe, Methodize takes a closer look into some of the new version’s recommendations and their impacts on medical device manufacturers.
In June 2016 Revision 4 of MEDDEV 2.7/1 Rev 4 replaced the December 2009 version. Not only did the document’s length increase from 46 in 2009 to 65 in 2016, but also includes more detailed and expansive requirements for clinical data.
This MEDDEV is a guidance document and therefore there is no implementation period. Notified Bodies may currently accept a Clinical Evaluation Report (CER) based on Version 3, but in the immediate or near future they may expect to see reference to Version 4. Therefore it is important to start using the new version as soon as possible. This blog post guides you through this new MEDDEV by answering six questions:
1. What has (not) changed?
The general principle remains that the manufacturer must use clinical data to demonstrate compliance with relevant Essential Requirements (Annex I of the MDD 93/42/EEC). Such data still has to be based on (pre-market) investigations done with the subject device, as well as on investigations done with other devices and data from post-market surveillance (PMS) activities and vigilance activities where appropriate. Clinical data still need to be collected, appraised and analyzed, but the level of detail of how this should be done, what methods are acceptable and when this should be done are almost all new.
2. When to do a Clinical Evaluation?
Clinical evaluation should be conducted throughout the life cycle of a medical device, including its design stage. This is an ongoing process and documentation should reflect this. The frequency of CER updates should be justified by the manufacturer, taking into account relevant factors such as risk, scientific developments and design changes. If relevant data that could potentially change the clinical evaluation is collected through PMS, the CER should be revised. Innovative or high-risk devices should have their CERs revised annually; other devices should do this at least every two to five years. Manufacturers must justify these frequencies.
3. How to perform a clinical evaluation?
The staging of a clinical evaluation (outside of your specific class of your device, e.g., class III obviously more stringent that class IIa or IIb) involves defining the scope and planning, data identification and appraisal of each data set; analysis of the data; and finalization of the CER. For most manufacturers this will sound familiar, but the updated MEDDEV describes these stages in detail. The requirements regarding who should perform clinical evaluations are now more detailed. The same is done regarding the scope of the evaluation; here, too, more detailed requirements provided. There is also now guidance on where and how to search for literature, and how to record the process of collecting, appraising and analyzing these articles.
4. Can equivalent devices still be used?
It is still possible to use data from an equivalent device. But the concept of “equivalence” is now clearly defined and the room for interpretation has become much smaller. Equivalent devices should be almost identical; Appendix A1 of the MEDDEV covers demonstration of equivalence. Clinical, technical and biological characteristics must be considered, and they are listed in great detail; all three groups of characteristics need to be fulfilled. The concept of “different” is described in this context, as well as the steps required to verify this concept. In practice, the use of equivalence will be limited to devices of the same manufacturer, and qualifying devices must be part of the same device family. Even identical devices of different device generations would require careful consideration in order to be acceptable as equivalent devices.
5. What will a CER look like?
The latest revision of the MEDDEV is clear in that it not only requires analysis of clinical data, but also requires manufacturers to be transparent about methods used and the steps taken. A substantial part of a CER should contain a log of how this evaluation was performed. You must therefore have appendixes that include your search strategies, full search results, appraisal strategy and results, analysis of the data, and a clear and functional list of references. All articles and reports should also be available for a reviewer to verify. Abstracts will not be accepted.
6. What about the Medical Devices Regulation?
The Compromise Consolidated text of the proposed Medical Devices Regulation (MDR) was published in June 2016. It is expected that the MDR will be applicable in the last quarter of 2019. The Regulation requires high-quality clinical evaluations. This MEDDEV takes a firm step in that direction. Working with the updated MEDDEV will help manufacturers to prepare for the coming legislation.