Fourth Italian Notified Body Designated Under MDR As Numbers Reach 22
July has been a good month for Italian notified body designations under the MDR. Their number has doubled this month.
You may also be interested in...
The regulation of companion diagnostics will be far stricter under the IVDR than the current IVD Regulation. EU life sciences regulatory lawyer Elisabethann Wright provides an overview and explains how companies should prepare for compliance.
Due to a lack of clarity in the MDR wording around which devices should be accompanied by implant cards, there is a risk companies may not supply them when patients would benefit. TEAM-NB offers guidance.
BSI would have been disappointed if it had received the comments featured in the first expert panel opinion, but vice-president Gary Slack believes the report provides many insights and opportunities around how this scrutiny process will impact the sector.