July 6, 2021
EU MDR & MDD Redundant Certification
An MDD-certified device is generally eligible for participation in the EU MDR Article 120(2) and/or (3) 2024 transitional buffer.
An MDD-certified device is generally eligible for participation in the EU MDR Article 120(2) and/or (3) 2024 transitional buffer. In that case, the MDD DoC can remain in effect (pursuant to certain EU MDR limitations) until replaced and/or supplemented by an EU MDR certificate and DoC. But once EU MDR conformity is achieved, then I know of no legislative reason to thereafter redundantly maintain the MDD certificate, though I suppose there could be business reasons for such redundancy. For the latter, it would mean a) that the manufacturer is willing to pay the NB(s) for the additional/duplicative conformity assessment services; and b) if the same NB will be used for both certifications, then such NB i) has the bandwidth and willingness to support such redundancy; and ii) such dual certification doesn’t violate the impartiality clauses (such as those in 4.2.4 regarding self-interest and familiarity) of the ISO 17021 standard(s) governing the NB. Other than that, I can’t bring to mind other reasons that would prohibit such dual certification by a single NB. But be sure to consult the NB involved so as to determine its particular stance on the matter.