Five years ago I wrote about the new MEDDEV 2.7/1 Rev. 4 guidance document for preparing CERs. When that guidance was issued, Notified Bodies widely communicated that while it referred to the MDD, it was written with the upcoming MDR rules in mind. The new MEDDEV guidance served as fair warning for what to expect […]
MEDDEV and MDCG Guidance Documents for MDR CERs Is MEDDEV 2.7/1 Rev. 4 Still Relevant?
