Re: Is exclusion of Design and Development Controls permitted for Class 2B Devices ?
Hi,
According to the MDD, for a class IIb conformity assessment you could apply either annex III + annex VI (or V), or annex II (exc. point 4). The QMS required by the former (either annex VI or V) doesn't require D&D controls. However, if one goes by annex II then D&D controls are required.
Cheers,
Ronen.