Category - Unannounced audits

medicaldeviceslegal

New MDCG guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions

When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]

medicaldeviceslegal

EU Court decides TÜV Rheinland / PIP breast implants case

It has been sort of hanging over the medical devices market for quite a long time: the TÜV Rheinland case about the PIP breast implants. This case is the direct result of the PIP breast implants scandal, which had a profound influence on the new EU MDR in the making. We had the Advocate General’s opinion […]

medicaldeviceslegal

Surprise! More on unannounced audits, this time on software

Further to my recent posts on unannounced audits I have been thinking about how unannounced audits could play out in an area that becomes more and more important: standalone software. Software medical devices The majority of standalone software under the medical devices directive falls in the scope of rule 12 of Annex IX of the MDD […]

medicaldeviceslegal

Surprise! More about unannounced audits

If you’ve missed the 2014 RAPS conference you’ve missed out on the opportunity to learn a lot about unannounced audits by notified bodies. Not only were the notified bodies themselves out and about at the conference and very approachable to discuss all kinds of technicalities, there were also several very practical sessions with a lot […]

medicaldeviceslegal

More movement – new rapporteur for MDR, same for IVDR

Finally things start moving again in EU medical devices regulation dossier: the new rapporteur for the Medical Devices Regulation was appointed, replacing Dagmar Roth-Behrendt. It’s Glenis Willmott The new rapporteur is UK MEP Glenis Willmott, of the S&D group in the European Parliament, who is certainly familiar with health issues as she has served for example as […]