Clinical documentation: Implementation of the new MEDDEV 2.7.1 rev. 4
Revision 4 of the MEDDEV guidance on clinical evaluation (MEDDEV 2.7.1 rev. 4) was published at the end of June 2016. The document contains some new recommendations for Clinical Evaluation Reports (CER) of medical device manufacturers. As the new MEDDEV on clinical evaluation has taken effect immediately without a transitional period, medical device manufacturers must now respond rapidly and review their CERs as fast as possible, making any necessary alignments. TÜV SÜD will implement the recommendations from MEDDEV 2.7.1 Rev. 4 in three phases and will require manufacturers to submit initial confirmation of conformity as early as the first regular audit in 2017. This procedure is based on the assumption that the requirements from Directive 2007/47/EC have been fulfilled and that no additional requirements are published by the European Commission.
Given the scope of the changes and the lack of transition period, the question arises of how manufacturers can transition seamlessly and how the required confirmation of conformity can be delivered. TÜV SÜD has thus decided on a three-phase plan and will implement the new MEDDEV guidance documents in the following stages:
December 2016: Within six months of publication of revision 4 – i.e. by the end of December 2016 – manufacturers should have prepared a gap analysis and clinical evaluation plan (CEP) for implementation of the new requirements. TÜV SÜD will verify these documents as part of the first regular audit in 2017.
January 2017: From January 2017 at the latest, manufacturers must begin to implement the new MEDDEV and align their existing Clinical Evaluation Reports. The order in which they process their CERs should depend on the importance of the device in question for their activities and on the level of risk associated with the product. Clinical Evaluation Reports for new applications from January 2017 must comply with the new specifications of MEDDEV 2.7.1 rev. 4.
December 2018: All Clinical Evaluation Reports of medical device manufacturers must comply with the recommendations of the new MEDDEV 2.7.1 rev. 4 by December 31, 2018, at the latest.
TÜV SÜD’s Global Clinical Focus team is happy to answer any inquiries concerning the introduction of MEDDEV 2.7.1 rev. 4 in TÜV SÜD audits and its implementation by manufacturers: firstname.lastname@example.org