Class I (exempt) - US v EU? - Medical Devices Group

Principal Consultant at Class Three, LLC

July 2016

< 1 min reading time

I’m largely ignorant of how Class I devices get on the market and then what happens next. I typically work with Class III, and sometimes Class II. However, I’ve started running into early-phase start-ups with a basic technology that could be developed for use with a range of indications. Obviously, it’s ideal if they can get on the market with a Class I indication quickly and start generating revenue to support future develop of other indications with higher development and regulatory costs.

That much, I know. Where I’m challenged is the question of US or EU first, especially because lack of transparency in the EU means you don’t really know how it works until you go through it. Are there any regulatory costs associated with either path? Do you even need an NB in the EU? If so, does the NB eventually come look at the tech file? Is this typically done annually? I think the manufacturer would pretty much have to be ISO 13485 certified, right?

On the US side, does anyone have experience with how soon/frequently you are really likely to get inspected by FDA if you make ONLY a Class I (exempt) device or devices? And how soon this is likely to happen after first listing?

Any other information that might help me advise clients on the US vs EU question for a Class I (exempt) would be much appreciated.

source: https://www.linkedin.com/groups/78665/78665-6164116738096066565

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Posted by Julie Omohundro

Asked on July 27, 2016 12:00 am

758 views

	Private answer Great questions. I am hoping for even better responses. EU people especially. Marked as spam Report spam
	Private answer Dr. Patrick Druggan Under Annex VII of 93/42/EEC there is no requirement for an accredited QMS, though you must have a vigilance procedure. You will need to notify the competent authorities in the territories you are selling in. The NB will not review the file if it is a standard Class I - not measuring and not sterile. You will need an authorised representative within the EU though. You will need to check 2007/47/EC to see if this has been updated just to make sure, but this is fairly current. Marked as spam Report spam
	Private answer Mateusz Pawelec I agree with Dr. Patrick Druggan. In simplification (for MDD Directive): All you need to register 1st class medical devices, and be able to put CE mark on your device, is Declaration of Conformity that the product complies with the directive / standards. Declaration is written by the manufacturer. For devices in Class 1m, 1s, 2a, 2b, 3 apart from the declaration of conformity (manufacturer) you need a certificate of conformity, which is admitted by NB (From what I remember – certificate for max 5 yrs. + periodic audits) . For ISO 13485 - it is not required. It is good practice defining a standard, which may be (but not have to be) required by your business partners. However, usually you do ISO 13485 and ISO 14971, because if you produce medical devices from higher class (and NB issues a certificate) it usually meant that you already meet the ISO requirements. 1st class: Declaration of Conformity 1st (m,s),2nda 2ndb, 3rd : Declaration of Conformity + Certificate of Con Marked as spam Report spam
	Private answer http://ec.europa.eu/DocsRoom/documents/10272/attachments/1/translations/en/renditions/pdf Marked as spam Report spam
	Private answer I also agree with Dr druggan has it spot on for the EU requirements Marked as spam Report spam
	Private answer I also agree with Dr Druggan. Marked as spam Report spam
	Private answer Julie Omohundro Thanks to everyone who has commented thus far. I fielded this question to a number of resources and have gotten a lot of very helpful information and insights. I plan to summarize all of the responses at some point and will post that summary here. In the meantime, if anyone has more to add, please do! Marked as spam Report spam
	Private answer Gavin Ritz Just done it few ago in und USA, I used a professional consultant. Prepare your IMDRF document, then she can breeze it through for u, costs about $10k & u should get registered mine took 1 week Marked as spam Report spam
	Private answer Hi Julie - the US is extremely easy as it just takes registering the facility and listing the devices after having a compliant quality system to meet the cGMP requirements. In most cases design control is not required for the US except in very specific cases. Marked as spam Report spam
	Private answer Dr. Joy Frestedt Product technical file will also need a clinical evaluation report (CER) to assess clinical benefit and risk in order to comply with essential requirements regardless of the device class. Marked as spam Report spam
	Private answer Olivier Zarza Hi Julie, Although your device is of Class I, you will need to: - Ensure your device complies to the relevant essential safety requirements of Annex I, - Use standards, preferably harmonized ones, - Perform a Risk Analysis and Clinical Evaluation, - Compile a Technical FIle, - Create and sign a Declaration of Conformity, - Your EU Rep will have to register your device to the competent authority where he/she is located, - Notifify the product/distribution in some countries if you plan to market there: France, Spain, Italy, Portugal, Belgium, etc.. For your QMS, you will need at minimum complaint handling, vigilance and CAPA procedures. ISO 13485 certification is not required, but will definately help in case you apply to your customer's tenders. If your Class I device is sterile and/or has a measuring function, a Notified Body will have to be involved with a focus on these aspects. The above requirements will apply as well. Hope this helps :) Marked as spam Report spam
	Private answer Olivier Zarza Even though it is a Class I device, your device need to comply to the relevant essential requirements of Annex I, have a Technical File which will include not only the Risk Analysis but also the Clinical Evaluation. Your authorized rep will have to register the device(s) to the Competent Authority of the country where he/she is located. Finally, you will have to do a product and/or distribution notification in certain countries such as France, Belgium, Spain, Portugal, Italy and others (if you market in these countries). As far as QMS, ISO 13485 certification is not required but does help a lot to apply to customers public tenders in various EU countries. You will however need at minimum a complaint, vigilance and CAPA procedures. Marked as spam Report spam
	Private answer Please let me know if any of your clients require an authorised representive in Europe. We have significant regulatory, manufacturing and market development experience in a number of European countries. Marked as spam Report spam
	Private answer Daniel John To sum it up, there is no difference in the requirements with respect to MDD 93/42/EEC for Class I, IIa, IIb and Class III devices. All requirements apply to all class of devices, only the depth of information varies/increases with the classification, except for the PMCF, which has become mandatory for all new Class III devices, which has taken literature route for clinical validation. Marked as spam Report spam
	Private answer Sonja Holten ISO 13485 is not mandate, it's a tool. EU and US have different rules. A class 2 for FDA might turn out to be a class 1 in the EU. FDA will make it easy if there is a predicate device. EU doesn't allow for such rationales. You have to do all your homework for each device. EU does not require notified body involvement for class 1. You do however report registration to the CA, for non-EU that requires a legal representative. In the EU having it as a medical device depends on your intended use. It is not possible to 'make' it a medical device. A EU medical device might require additional compliance regarding other applicable CE regulations. NB will check your technical file during certification audits and or inspections. Registering a class 1 in the US can be done via listing on company register. There are a million ways to mess up your filing. But EU provides better and stricter guidance once you know where to look. Having the support of a specialised regulatory consultant is not a luxury but a commodity when preparing for an EU market introduction. Marked as spam Report spam
	Private answer Guido Vezzu Hi Julie, Swissmedic provides a nice overview on what is needed for MDD class I to III: https://www.swissmedic.ch/medizinprodukte/02636/03167/index.html?lang=en Please note the difference between MDD class I and class Is/Im Marked as spam Report spam
	Private answer Dr. Patricia Chinwe Onuoha PhD/MD,BCCS, Sonja Holten, you know that international standard operating procedure is not absolutely working absolutely in the underdeveloped world and developing world. For instance in Nigeria,upon all the trainings, so many users of health devices does not follow the steps and many a time, the equipments have expired and they will still be in use. All class are not applied as supposed. Marked as spam Report spam
	Private answer South Africa as a country is undergoing new Regulatory requirements for medical devices and IVD's. This also includes new licencing procedures for vetted Medical Suppliers. In the long term ISO 13485 will aslo be applied as a tool for QA. I will follow this post with keen interest as we evolve with this process mandated by the South African Department of Health and regulated by the Medicine Controls Council (soon to be SAPRA) Marked as spam Report spam
	Private answer Daniel John FDA: Class I devices are under "General Controls" which includes registration and listing, (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. I don't think FDA will inspect manufacturers of Class I devices, especially if the manufacturer is located outside USA, unless there are subsequent MDR's regarding the device/s which will raise red flag. Marked as spam Report spam
	Private answer Julie Omohundro Olivier Zarza Could you elaborate on the need to notify certain countries, beyond the CA where you or your AR is based? I haven't been able to locate a source for this requirement. Is it country specific? Marked as spam Report spam
	Private answer Julie O. With the implementation of Eudamed you no longer need to notify each EU country , only the one where the manufacturer/EC rep is located. Certain countries have additional listings, though - especially to participate in tenders. Marked as spam Report spam
	Private answer Olivier Zarza Julie: Sure, please send me a short email at olivier.zarza@skynet.be so i can send you some more details. Marked as spam Report spam
	Private answer Julie Omohundro Olivier, I sent you an email. Marked as spam Report spam
	Private answer Marco Farina, Ph.D. In Europe the Class I medical device is under auto certification regime so you need an engineer to sign the project and another one to certificate it. No clinical trials. But at the same time in Italy for example you need to contact the ethical committee (sending an official request to the health system ministry) and in 30 days you have the possibility to test your device in one of hospitals you are in contact with. They will follow the physicians while using your device and write a report. In USA you need the 510k and by 90 days you receive the response. You have to provide them a list of devices already approved that are similar to yours and the name and the certifications of the company that will manufacture it, the labeling.... Marked as spam Report spam
	Private answer Mikel Condie Curry Following Marked as spam Report spam
	Private answer Prakash Pcgoliya We plan to start production in India of Teflon FEP tubes with radio opaque stripes which we will be selling to IV Cannula manufacturers not only n India but also to the US and Europe What are the approvals required ? udeymedtubes@rediffmail.com Marked as spam Report spam
	Private answer Julie Omohundro I've put together a table that attempts to summarize all the comments I received in response to this question here, and in the RAPS forum, and individually. If you'd like a copy, PLEASE contact me via a LinkedIn message or directly via email to Julie (at) class3devices.com. Please DON'T post a request for it here in the comments section of this discussion. Thanks again to everyone who contributed to this discussion! Marked as spam Report spam

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