In order to comply with the EU regulation on medical devices, the regulatory stage Clinical Evaluation Report (CER) has been the focus of renewed attention by the medical device industry. At Mtech Access we have seen a concurrent upsurge in the requirement for systematic literature reviews at this early regulatory stage, as opposed to being reserved later for health technology assessment processes, such as the NICE Medical Technologies Evaluation Programme (MTEP).
There are a number of systematic reviews required now at the early regulatory stage:
- The so-called “State of the Art” literature review, described in the reporting guideline, MEDDEV 2.1/7 Rev.4, considers all other treatments available for the eligible patient group, including pharmacological and surgical interventions, as well as direct competitor devices. Each intervention or device must be appraised in terms of its relative risks and benefits versus the alternatives and the device being evaluated will be compared to this landscape, in a similar fashion. This review must be conducted even if there is a paucity of data, in which case evidence gaps should be identified and acknowledged.
- The review of clinical evidence for the device under evaluation, will include a summary of unpublished trials, as well as a full literature review of published literature; all of this evidence will need to be presented uniformly in an organised and accessible data table. The new regulations have placed increased emphasis on the objective quality assessment of the evidence base, including consideration of how well the trial population matches the indication for which the device is intended.
The “State of the Art” review is a useful basis for establishing the clinical context of an intervention for the later stage NICE MTEP submission and the review of clinical evidence for the regulatory CER is very similar to the clinical review required for a NICE MTEP submission.
Given that systematic review methodology is now more stringently applied from regulatory affairs to reimbursement, Mtech Access are interested in increasing the efficiency of data searching, extraction, appraisal and documentation processes for our clients. For example, it is possible for the early stage CER reviews to be collected in such a way that outcomes will be relevant for the later stage MTEP review and for these to be kept updated via a literature surveillance service, rather than charging for an entirely new review at each update or for the MTEP review stage.
1European Commission. MEDDEV 2.7/1 Revision 4. Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, 2016.
If you are interested in hearing more about our systematic review and network meta-analysis services, including our efficient literature surveillance update service, please contact us today