My name is Erik Vollebregt and I am a Life Sciences and IP lawyer based in Amsterdam, one of the founding partners of Axon Lawyers as of 1 September 2011, with a particular focus on medical devices.
This blog is intended to discuss and inform about European Union legal and regulatory developments in medical devices.
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Read your good article from RAPS about unannounced audits by NBs. The table says class I product manufacturers also have 3 yr inspection rate. But Class I manufacturers typcally do not have a NB. Please clarify. Thank you
Hi Nils-Ake, when it concerns a class I device with measuring function or that is sterile a notified body is involved to assess these aspects as per Annex VII. That is what this refers to.
Right, thank you.
Let me please know if you also deal with FDA clearance in order to enter the US market.
Hi Jacob, I don’t do that personally but I have consultants in my network that do and would be happy to put you in contact with them.
do you know whether a CRO or an academic research organisation can be a sponsor for a medical device trials of CE mark product for a non approved indication in EU? in US if the study is part of IDE submission?
Hi Catherine, the answer is yes. It is quite common for academic research organisations to initiate a so called investigator initiated trial with devices and there is nothing that prevents them from being sponsor in the EU if they fulfill the requirements imposed on a sponsor under national law. I believe the same is true in the US.
Hi Eric, we are playing with an idea of creating a mHealth-application, capable to improve the quality of life of many patients worldwide. To enable the usage of our app we’ll need to set up a mini-device, (linked to the non-invasive sensors, all on the skin surface of patients like for ex. EMG), enhancing and digitalising signals, coming from the sensors. This device will forward the digitalised information wirelessly via bluetoth to a smartphone. At the end we would have two final products: the mini-device and a set of smartphone games based on med. protocols.
Assumed we use already existing CE-certiified sensors and the mini-device will be produced according to the CE-norm of course, should be both the device & the smartphone app be considered as medical products? Or the device only? What about the smartphone itself?
I read a summary of the recent FDA update regarding the m-health. Do you know if there are any additional regulations we have to consider in the EU for both the device and the app please? Are the regulations country-specific ? …we are just trying to estimate if it’s worth to go this way with a medical product/medical app or if the burocratic effort would kill the little start up project…what would be definitely pity especially for the potentially targeted patients.Thanks so much in advance.
With kind regards, Karina
Hi Karina, that’s a lot of questions in one comment! How about discussing this by telephone to make sure you get all your questions answered? You can book in a free Question Time consult with me for that on my firm’s homepage (www.axonlawyers.com). Speak to you soon! Best regards, Erik
Hi Erik, thank you. Will do. Happy to talking to you later, Karina
I have a question about a software that measures the time spent on forms which are used by patients during the clinical investigation stage so that the hospital can evaluate the effectiveness of patient feedback which will directly effect the quality of clinical investigation results. Can this software be class I measuring device?
Dear Oguz, it won’t be a measuring device because a measuring device has to measure a physiological or anatomical parameter or a quantity or a qualifiable characteristic of energy or of substances delivered to or removed from the human body, which time is not (see the guidance at http://ec.europa.eu/growth/sectors/medical-devices/documents/guidelines/files/meddev/2_1_5____06-1998_en.pdf). Also doubtful whether this is a medical device in the first place, because this does not seem to be for the benefit of a specific patient. Hope this helps!
I am writing to let you know we have republished your post about the MDR impact on software qualification as medical device on MedTech Engine. You can have a look at the link below.
We ensured you receive all accreditation for this article.
If you have any further questions or comments please do not hesitate to get in touch.
Thanks for letting me know! Best regards, Erik
Thanks for all the information on all things new regarding MDR and IVDDR.
Any idea if the EU will publish guidance on the exemptions for heath care establishments/institutions – especially when working with academia? We make a lot of one or two off devices and the new regulations and requirements of 13485 will be rather onerous to implement.
Also would you or any of your readers know of medical device regulations or requirements prior to 1970.
Hi Carena, your quess is as good as mine for that. Since the member states are overseeing the application of the home made devices rules your local competent authority is also a good place to start for asking. Before 1990 there were no EU harmonised medical devices rules, so that was all national law.
One of our staff asked our competent authority if a simple spreadsheet used in dose calculation was a medical device (we thought it might be, but hope for a negative answer) and we were informed yes it was. The next problem is how on earth does any hospital find all such spreadsheets and bring them under MDR/IVDDR/13485/15189 control……does this extend to all calculations using standard methods and formulae ….. even on paper??
Hi Carena, this is a quality system problem for the hospital. I’m not sure what member state we are talking about but normally the hospital should control these kind of things even from a hospital risk management perspective. If you look at the old MEDDEV 2.1/6 and the new MDCG guidance on software then all ptrogrammable logic that has an input-output function for data to be used in treatment or diagnosis could be regulated as medical device. The only thing the hospital can do take inventory of all the algorithms used in the hospital and then decide per algorithm whether it is a regualted device. Under the MDR and IVDR there is the article 5 (5) regime for home brew devices of course, but that still requires this work. It saves having to go to a notified body with the higher risk software. If you would like more detailed advice about this, let’s talk further. Best regards, Erik
Hi Erik, is there an easy way to find out which member states have published their plans for enforcement of MDR per Article 113 and what the penalties might be?
Hi Anne, normally EU regulation in Eur-Lex will also have an attached page with national implementing law, but this may not be ready for the MDR yet as mny member states have not finished implementing legislation yet.
Where can I obtain a copy of your article:
How Manufacturers Can Ensure Control over Subcontractors in the EU
This article was originally published in SRA
16 Nov 2009
I think that should be available from the publisher here: https://generics.pharmaintelligence.informa.com/SC095783/How-Manufacturers-Can-Ensure-Control-over-Subcontractors-in-the-EU