Clik here to view.
Improving implementation: the Code for Notified Bodies
It’s finally public: the Code of Conduct for Notified Bodies under Directives 90/385/EEC and 93/42/EEC “Improving implementation of the European CE certification of medical devices through...
View ArticleClik here to view.
Critical analysis of the European Society of Cardiologists’ report on medical...
Reader warning: this will be a longer-than-usual post, because I did not have time to write a short one (to cite the many philosophers and writers credited for this quote). The European Society of...
View ArticleClik here to view.
Outlines of the medical devices Recast become more fixed with Council...
Since the High Level Meeting end of March where the Commission outlined its plans for the Recast of the Medical Devices Directive and took stock of the feelings about it in the industry, the project...
View ArticleClik here to view.
New EU guidance on Post Market Clinical Follow-Up Studies published and other...
The EU just released its first MEDDEV of a number that were agreed upon in the recent MDEG meeting. More are expected to trickle onto the Commission’s devices web pages in the coming days/weeks. It is...
View ArticleClik here to view.
The new EU MEDDEV on stand-alone software as medical device
Some time ago I already gave you a look under the hood of it and now it is here, the new MEDDEV on stand alone software: an interesting document that provides a lot of much-needed guidance for the...
View ArticleClik here to view.
Marketing surveillance shaping up pre-Review with Dutch Minister feedback to...
Interesting developments after the joint plan for action that Commissioner Dalli sent to the member states in the beginning of February this year urging them to step up market surveillance in order to...
View ArticleClik here to view.
Economist, why so pessimistic about open source medical devices software?
I read an interesting article in the Economist’s Technology Quarterly of June 2nd-8th of 2012, p. 17-18, on open source medical devices software. Let me summarise for you: the article starts by showing...
View ArticleClik here to view.
In Vitro Diagnostics seminar at Axon Lawyers on 12 September
Dear readers, I hope you don’t mind some modest self-promotion: my firm is organising a seminar on EU recent (and future) legal and regulatory developments with respect to in vitro diagnostics, with...
View ArticleClik here to view.
New EU medical devices regulations proposals out – first impression: nothing...
Today was a big day with a half hour press conference by Commissioner Dalli (for Twitter summaries see here and here) to festively launch the two much anticipated EU medical devices regulation...
View ArticleClik here to view.
“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...
View ArticleClik here to view.
Unannounced notified body visits recommendation imminent – amend your...
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...
View ArticleClik here to view.
ENVI’s amendments
ENVI’s amendments, following those of IMCO have been published now after translation, see here for IVDs and here for medical devices. This accounts for the biggest load of the amendments (297 – 907 on...
View ArticleClik here to view.
ENVI’s 29 may debate on medical devices
The fog of war that I wrote about with respect to the tsunami of amendments is lifting with the discussion of the amendments in the ENVI committee today. It was a very interesting debate, and I’ll...
View ArticleClik here to view.
In the mean time… joint immediate action plan, unannounced audits and other...
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...
View ArticleClik here to view.
Surprise! Unannounced notified body audits Commission recommendation finally...
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...
View ArticleClik here to view.
Happy Holidays, and an exciting and innovative New Year to you – and a...
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...
View ArticleClik here to view.
The authorities are not your friend anymore; and neither are notified bodies
Have you seen Mr Robot? If not, watch that series. With the MDR and IVDR adoption in sight (currently scheduled for Q1 2017) I see a number of developments in the market, all converging on the higher...
View ArticleClik here to view.
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...
View ArticleClik here to view.
The notified body conundrum
In my recent post about potential mass extinction in the EU IVD market as a result of the IVDR and the limited number of notified bodies that look to be applying for IVDR status (and the incredulous...
View ArticleClik here to view.
Bottlenecks, Brexit and stalling CAMD roll-out
With the summer holidays about to happen and the halfway point of the three year transitional period for the MDR on the horizon, let’s take stock of where we are. If you are a manufacturer and have...
View Article