Clik here to view.
Happy IVDR day!
Happy IVDR day my readers! My apologies for the low level of activity on this blog the last time. I’ve been very busy with MDR and IVDR work. And of course I have been working hard on the second...
View ArticleClik here to view.
Finally remote initial audits, or not (yet)?
When the Commission recently published the Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits...
View ArticleClik here to view.
New MDCG guidance on temporary extraordinary measures related to medical...
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...
View ArticleClik here to view.
The MDR and the Covid-19 recommendation – a possible template for fixing the...
On 16 March 2020 the Commission published the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19...
View ArticleClik here to view.
Welcome to 2020 – year of the proof of the MDR pudding
Welcome to 2020 – happy new year everyone. I don’t care if your conventions do not allow me to wish you best wishes after a certain date anymore. I wish you a happy 2020 because I genuinely hope you...
View ArticleClik here to view.
A not so happy MDR and IVDR Christmas Carol
MDR and Article 123 (3) (d) cookies courtesy of Medtech Europe’s Katalin Maté who baked them for a meeting – they were delicious! Just before the Christmas holidays the Commission updated its rolling...
View ArticleClik here to view.
Bottleneck of bottlenecks for notified body capacity
People that are downplaying the notified body bottleneck may need to start to revisit their position with notified body LRQA now also dropping out of the notified body pool for medical devices and...
View ArticleClik here to view.
Don’t give me Brexit problems, give me Brexit scenarios
At the moment I spend a considerable amount of my lawyering time answering questions concerning Brexit problems. My first question back to the company is: what are your Brexit scenarios? Did you make a...
View ArticleClik here to view.
First notified body EU MDR designated!
BSI reports that it has achieved designation as UK notified body for the MDR. So far, it’s the first notified body to appear in the NANDO database with an MDR designation – see here for scope and here...
View ArticleClik here to view.
MDR and IVDR in 2019: up or out, sink or swim
Happy new year and welcome to 2019, a truly decisive year for the medical devices industry with interests in the EU. If you haven’t spent any time so far getting ahead of events relating to the MDR and...
View ArticleClik here to view.
Ceci n’est pas une période de transition and first reaction to the Implant Files
As we are just past the halfway point of the MDR transitional period for the MDR and are well into the one for the IVDR there is one thing that has become very very clear: the transitional period in...
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 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.
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 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.
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.
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.
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.
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.
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 Article![ONEW – KAKERA -Unmei no Piece- – EP [iTunes Plus M4A]](http://is1-ssl.mzstatic.com/image/thumb/Music221/v4/d0/fb/86/d0fb86a5-ba60-4bea-41fb-7f54c125f518/VEATP-45908.jpg/296x296bb.webp)
/pic9814888.png)
