October 19, 2016
MEDDEV 2.7/1 – Revision of an essential guideline for the European medical device market
Previously, we reported on the European requirements of clinical evaluation of your medical device, throughout the whole life-cycle of your product and regardless of your device’s classification. The new MEDDEV 2.7/1 requirements, as outlined in revision 4 of the respective document, are now being implemented at the Notified Bodies. Thus, time to have a closer look on the key changes.
Clinical evaluation during the life cycle
The new revision emphasizes that the clinical evaluation is an ongoing process that shall be conducted throughout the life cycle of a medical device, including the design phase and the post-marketing phase. Timelines for updating the clinical evaluation are outlined and considerations to be taken into account when defining and justifying the frequency are discussed. In general, these timelines have become a lot more stringent.
Qualification of the evaluators
The new revision is more specific and detailed on the qualifications required for the evaluators performing the clinical evaluation. Criteria include general qualifications, training and education requirements, as well as specific knowledge about the device under evaluation and the clinical context in which the device is applied. In addition, the evaluator shall provide a declaration of interest, which shall be filed with the Clinical Evaluation Report (CER).
Demonstration of device equivalence
Likely one of the biggest changes of the revision is the guidance on the use data of equivalent devices for conformity assessment of the device under evaluation. The list of requirements to assume equivalence is very thorough, therewith restricting the manufacturer to demonstrate equivalence. For example, a device can only be considered an equivalent device when the full non-clinical information of the respective device is available and added to the technical documentation of the device under evaluation. Intuitively, as it is hard to gain access to the technical information of competitive products, the demonstration of conformity based on the literature route has become very restrictive.
The revision has become stricter in the requirements of data that shall be included in the evaluation. In example, whereas revision 3 defines that ‘a manufacturer chooses to use clinical experience data’, revision 4 outlines that all data generated and held by the manufacturer shall be identified, entirely disclosed and made available to the evaluator and documented in the clinical evaluation report’. This may include data from pre-market clinical investigations, as well as post-marketing surveillance procedures. Instructions are provided for the evaluator to assess the data on quality and relevance, and inclusion or exclusion of data shall be justified.
Data appraisal and analysis
The revision provides a comprehensive guidance for the evaluator on how to appraise and analyze data provided for the clinical evaluation. As such, it is expected that the notified bodies shall expand their review on the data appraisal and analysis methodologies. In example, it is required that the analysis includes review of consistency and alignment between the evaluation, information provided by the manufacturer, the risk management documentation, and state of the art.
The revision not only provides guidance for the manufacturer, but also includes a 9-page appendix describing the activities of the Notified Bodies. The procedures for assessment of the clinical evaluation reports, the supporting data, and the design dossier are described, as well as the specific procedures and expertise that the Notified Bodies should have in place. The extend on which this information is written indicates that the MEDDEV 2.7/1 rev. 4 will serve an essential role for the Notified Bodies.
It is important to realize that Notified Bodies are reviewing medical devices according to the updated requirements – for devices that are newly introduced to the European market, as well as for devices that are yet market-available. This does not only imply that a CER should be in place, but also that this document is written conform the current guidelines.
Factory CRO has extended knowledge on and experience in performing and documentation clinical evaluations. Our expert medical writers can assist you in designing a new CER or updating an existing CER and are fully equipped to identify any gap between your CERs and the current requirements.
By Anne Leijsen