The release of the revised guidance regarding Clinical Evaluations (MEDDEV 2.7/1 Rev. 4) in 2016 introduced some significant changes to the process of clinical evaluation. The implementation of the MDR will bring with it relevant changes and while some may be relatively minor (e.g. the change in terminology from Essential Requirements to General Safety and Performance Requirements), others may have significant impact on the clinical data available and required to support your product.
The following list is not exhaustive, but does explore three of the most significant changes.
Clinical Evaluation Report (CER):
Although the MEDDEV introduces the idea of a clinical evaluation plan, the MDR is much more explicit regarding the required elements of this plan. Most of the defined elements outline information that was likely already gathered as part of the clinical evaluation process (e.g. intended purpose, target groups, methods and parameters used to determine the acceptability of the benefit-risk profile and residual risks and side-effects). However, some of the items listed in Annex XIV may require more detail for the clinical evaluation plan than had previously been included in the CER. In addition to these existing elements, the MDR also requires that a clinical development plan be included as a part of the clinical evaluation plan. The clinical development plan requires a long-term view of the planned clinical investigations related to the product, spanning from feasibility studies all the way through to post-market clinical follow-up studies.
Clinical Investigations
The MDR contains a few more specifics than were included in the MDD or MEDDEV in regard to when clinical investigations are required for class III products and implants. Essentially, all class III products and implants require a clinical investigation, unless they:
- are a line extension of an existing CE marked product;
- are equivalent to a device already CE marked where there is a contract in place to allow the manufacturer full and ongoing access to the technical documentation (see below);
- were lawfully placed on the market under the MDD/AIMDD, there is sufficient clinical data, and where device-specific common specifications have been adopted to which the device complies; or
- have been explicitly exempted (e.g. sutures, staples, etc.) and meet the applicable common specifications.
For classes I, IIa, and IIb, the MDR is relatively silent on when clinical investigations will be required. The MEDDEV provides more guidance on this than is present in the MDR and the increasingly stringent requirements on “sufficient clinical evidence” seen since the implementation of Rev. 4 is likely to continue.
Equivalent devices:
Although the MDR still allows for the use of equivalents, and even provides definitions of the qualifying characteristics that are essentially the same as those provided in the MEDDEV, there are additional requirements, particularly for class III devices, which are likely to make the establishment and defense of an equivalence claim more difficult than before.
In order to establish any equivalent device, regardless of device class, the manufacturer will be required to clearly demonstrate that they have “sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.” Exactly what constitutes “sufficient levels of access” is not explicitly defined, but the general consensus so far is that Notified Bodies are likely to insist that manufacturers either have access to the technical documentation for any claimed equivalent.
Questions:
If you have questions about writing or updating your CER, contact us at info@akrnconsulting.com
