Category - Audits

08-04-2020medicaldeviceslegal

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 […]

01-10-2013medicaldeviceslegal

Surprise! Unannounced notified body audits Commission recommendation finally issued

While everybody in the medical devices industry is still reeling from the ENVI vote results (of which we still don’t know what they are in detail because the documents have not been published yet), the Commission finally issued the recommendation on unannounced audits – I was starting to get worried it would never be issued […]

25-07-2013medicaldeviceslegal

In the mean time… joint immediate action plan, unannounced audits and other things over the summer

While everybody is focusing on the legislative process in the ENVI committee and (to a limited extent) on what the Council is doing, significant other developments are playing in the background. Joint Immediate Action Plan You may remember that as soon as the PIP scandal’s implications became clear, the Commission initiated the Joint Immediate Action […]

25-07-2013medicaldeviceslegal

In the mean time… joint immediate action plan, unannounced audits and other things over the summer

27-03-2013medicaldeviceslegal

Unannounced notified body visits recommendation imminent – amend your contracts and procedures now!

While everybody is running around about the MDR and IVD regulations proposals another storm is brewing in the wings: unannounced audits, which I announced earlier. Currently notified bodies “may” do unannounced audits under the EU medical devices rules. Now they will be required to do a minimum amount of unannounced audits. Required? Yes, EU member […]

05-11-2012medicaldeviceslegal

“U” is for unannounced audits – what’s up with those?

I visited the RAPS Regulatory Convergence conference in Seattle, which provides for a very nice opportunity to catch up with the European medical devices crowd that had gathered in numbers to explain the current changes in EU medical devices law to the US audience and to each other. Apart from the ever charming and authoritative Ms […]