A revision of European guidance MEDDEV 2.7.1, entitled "Clinical Evaluation: A Guide for Manufacturers and Notified Bodies" was issued in December 2009. The new revision aligns the EU guidance on clinical evaluations with the GHTF guidance document, SG5/N2R8:2007, which was released in May 2007. If you are familiar with the GHTF document, you will likely note that the new revision is nearly identical, and in fact, some sections have been transposed verbatim.
A comparison of MEDDEV 2.7.1 Revision 3 (December 2009) and Revision 2 (April 2003) will not be as easily identifiable. The format and layout of the new revision is much different than the document it supersedes (46 pages compared to 19 pages). While for the most part the content is similar, the wording has been changed to reflect the wording in the GHTF document, and minor changes have been made. Note that six appendices are now included, including a template for the Clinical Evaluation report. One new section is the description of the clinical evaluation process which was not detailed in the older version of 2.7.1. On this process, Revision 3 says:
To conduct a clinical evaluation, a manufacturer needs to:
- Identify the Essential Requirements that require support from relevant clinical data;
- Identify available clinical data relevant to the device and its intended use;
- Evaluate data in terms of its suitability for establishing the safety and performance of the device;
- Generate any clinical data needed to address outstanding issues;
- Bring all the clinical data together to reach conclusions about the clinical safety and performance of the device.
The guidance describes the procedure of how a clinical evaluation is performed in three steps, once the scope has been defined. They are:
- Identification of pertinent standards and clinical data;
- Appraisal of each individual data set, in terms of its relevance, applicability, quality and clinical significance; and
- Analysis of the individual data sets, whereby conclusions are reached about the performance, safety and presentational aspects (labeling, patient information and instructions for use) of the device.
Another noteworthy difference in European MEDDEV 2.7.1 Revision 3 compared to Revision 2 lies within the number of terms defined and the definitions of terms. In fact, the definitions for Clinical Data and Clinical Evaluation have been truncated from their more lengthy descriptions in Revision 2. The glossary of terms in Revision 3 now defines the two words respectively as:
- Clinical data: Safety and/or performance information that are generated from the use of a medical device.
- Clinical evaluation: The assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer.
The explanation of demonstrating equivalence has, in certain sections, been subject to a nominal change in verbiage. Unfortunately, the terms used are not consistent throughout Revision 3. Regardless of the confusion inherent to this inconsistent terminology, thankfully, the meaning is all the same.
The role of the Notified Body is discussed in Revision 3 of MEDDEV 2.7.1 (Section 10). In fact, the new revision specifically states that “this section of the document is intended to act as guidance to a Notified Body on the assessment of clinical evaluations provided by medical device manufacturers as part of technical documentation/design dossiers and as a part of their procedures for medical devices. It might also be useful as best practice guidance for national Competent Authorities in their market surveillance activities.”
Revision 3, Appendix F, provides a detailed example of a checklist that could be used by a Notified Body to assess whether or not the clinical data provided by a manufacturer is sufficient. Of course, this is a valuable tool for a manufacturer to use to assess the adequacy of their clinical evaluation. Similarly, Revision 2 also provided direction on the Notified Body’s decision-making (Sections 5 and 6), but it had been formatted as more general guidance, rather than specific bullet-points of possible criteria.
Revision 3, in concert with the Directive 2007/47/EC, reminds us that a clinical evaluation is required for all classes of medical devices, though clinical data can be variously obtained. For example, high risk devices and devices with a new purpose or clinical use are likely to be required to provide clinical investigation data, whereas medical devices with a long history of use and demonstrated safety may be able to use their compliance with recognized standards, a literature review, or clinical evaluations of equivalent devices.
We hope that this brief article has helped to clarify a few points of interest and distinction between the newly issued MEDDEV 2.7.1, Revision 3 and the version it replaced. Revision 3, along with other European guidance documents and legislation is available in our online Learning Library.