Category - Unannounced 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 […]

20-02-2017medicaldeviceslegal

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 […]

10-10-2014medicaldeviceslegal

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 […]

03-10-2014medicaldeviceslegal

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 […]

25-09-2014medicaldeviceslegal

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 […]

20-12-2013medicaldeviceslegal

Happy Holidays, and an exciting and innovative New Year to you – and a correction

You have a lot to look forward to next year unannounced notified body inspections will start (I hope you, your subcontracts and suppliers are prepared – if not, take a look at this instructive MedCert video), we will or will not close the project of the medical devices regulation revision before the elections during the […]

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 […]