For several weeks now new, substantially stricter rules have been in place for clinical evaluations. All notified bodies known to us now require the application of Rev. 4 of the corresponding MEDDEV 2.7/1. The absence of an updated clinical evaluation according to Rev. 4 during an audit is considered to be a major non-conformity.
We have adapted our processes and practice accordingly and in the meantime have produced several evaluations in line with the new guidelines. The first evaluation has already been approved by a notified body.