Oliver, thank you for that information! Until now I was under the impression that Class I's can really operate pretty much off the regulatory radar in the EU.
Original Message:
Sent: 28-Jul-2016 07:17
From: Oliver Bisazza
Subject: Class I exept - US vs EU?
Here is my favorite guide for getting Class I devices into MDD compliance:
Don't forget Step 6: notification to all applicable national Competent Authorities in Europe. Not all authorities require Class I products on their market to be notified, but several do. This can involve notification in a national database, potentially in a local language.
http://ec.europa.eu/DocsRoom/documents/10272/attachments/1/translations/en/renditions/native
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Oliver Bisazza
Director, Regulatory Policy, EMEA
Medtronic
Original Message:
Sent: 27-Jul-2016 23:36
From: Julie Omohundro
Subject: Class I exept - US vs EU?
Dan, thanks for your comments also. Point well taken on "exempt," although with many startups, the only exemption that seems to be of interest is...no 510(k). Granted, that's often because they haven't heard much of anything about the others.
I have yet to come across a situation in which ISO13485 certification was not a good idea.
I think the CER is likely to be a deal breaker when the principals are engineers. When they are academic medical researchers, to them it's just another clinical review article, and often the only part of process that they are comfortable with.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 27-Jul-2016 16:06
From: Dan O'Leary
Subject: Class I exept - US vs EU?
My first recommendation is to stop using the term exempt, because it is ambiguous. In the US a Class I device could be exempt from:
pre-market submission
design controls
Nearly all of QSR
UDI
In the EU, under the MDD there are no exemptions, only addition requirements for devices sold sterile or have a measuring function. These are often called Class Is and Class Im.
In the US, classify the device by finding the Product Code. That will tell you all of the things related to marketing and production except the design control application. You will need to implement 803, 806, 807 for registration and listing, and 820.
I infer this is not an in vitro device, so covered by the EU MDD. You need to classify the device following Annex IX. Work your way through the rules as if they were a flow chart. Document every applicable rule by number and the associated class. At the end, you picked highest class. Assume it is Class I and the device is not shipped sterile and does not have a measuring function. In that case, you will follow Annex VII. This means a technical documentation that demonstrates the device satisfied the Essential Requirements in Annex I including the Clinical Evaluation in Annex X. On June 30, 2016, Clinical Evaluation became much harder because of MedDev 2.7/1 Rev. 4. Create a Declaration of Conformity and apply the CE Mark. A Notified Body is not involved so there will not be any numbers next to the CE Mark. You will also have to implement the vigilance system in MedDev 2.12-1. You will also need to hire an Authorized Representative in the EU.
Annex VII does not require a QMS, but I recommend implementing EN ISO 13485:2012.
In my opinion, the Clinical Evaluation is a deal breaker for the EU. For example, “The evaluators should have at least the following training and experience in the relevant field: a degree from higher education in the respective field and 5 years of documented professional experience; or 10 years of documented professional experience if a degree is not a prerequisite for a given task.”
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Dan O'Leary
Swanzey NH
United States
Original Message:
Sent: 27-Jul-2016 10:34
From: Julie Omohundro
Subject: Class I exept - US vs EU?
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. It's great if they can get on the market with Class I indication quickly and start generating revenue to support future develop of other indications with a higher regulatory burden.
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 (and I mean real regulatory costs, like filing fees and NB fees, not product development costs like testing) associated with either path? Do you even need an NB in the EU? If so, do they eventually come look at the tech file? Is this typically done annually? I think you 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!
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
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