Paula McCarthy For many medical devices the regulatory requirements for EU and US are similar, it is important that the requirements of each market is assesed before embarking on a verification and validation program - time spent on researching requirements and proper planning will no doubt save money in the long run. Acorn Regulatory (who I work for) is based in Europe and has a great track record in helping small and medium sized companies to understand the requirements, and work with them to achieve CE mark.

Valerie Harding Thanks Paula. What kind of time-frame should a small to medium size device manufacturer expect to have in terms of getting the CE mark (aka. breaking into the market)?

Paula McCarthy Hi Valerie, it's very difficult to give a general time frame as it really depends on the complexity and the risk profile of the product. To give you a ballpark it could be anything from 6 months to 2 years.

Julie Omohundro Valerie, I think it's important to distinguish between what you need to do for compliance versus just the process of applying to the NB for CE certification.

You will want to get your manufacturing facility certified to ISO 13485 and you will also need documentation to support the performance and safety of the specific device you want to CE Mark. If you already have all of this in place, then the actual process of obtaining the CE certification to support the CE Mark should not take very long. If you don't, then you have quite a bit of work to do before you are ready to begin jumping through any hurdles.

Paula McCarthy Hi Valerie, I agree with Julie O., the timeframe I outlined included implementing systems necessary for CE approval such as quality procedures and specific testing requirements (not just preparation and submission of a technical file). The very first step is to have a gap assessment performed - both from a quality systems and technical data point of view. This will give you a realistic assessment of the work required and associated timelines and resources.

Julie Omohundro Joanne, you are quite right about ISO 13485, but, at least for device companies in the US, that's typically a moot point. If you are going to market in the EU, it is easier to follow the ISO standard than to make something up on your own. If your facility already meets the QSR requirements, any additional work you might have to do to meet the ISO standard is typically minimal. If you are a start-up that hasn't yet met QSR, meeting the ISO standard is a good way to start.

Valerie Harding Thanks Paula and Julie. Seeing that this is a good starting place, can you give any advice on how you would chose who to conduct a gap assessment? I don't think the medical device start ups and even the medium sized device manufacturers have the resources or the knowledge to have someone internal to do this.

Dear Valerie, what I would say is to classify your device as per Annex IX, then based on it you may choose the compliance route, there are various approaches defined in the directive. To perform the classification, you need to define the intended use of the device.

Julie Omohundro Valerie, look for someone who has good experience doing QSR and ISO 13485 audits. There are a lot of consultants with this background.

Paula McCarthy Hi Valerie, a consultant with ISO 13485 and European regulatory experience will be able to help you with this. Correct classification of the device in accordance with intended use/mode of action is important, along with identifying quality system gaps.

Gottfried Griesmayr Valerie, there are two points to check (as Paula said) and the timeframe will completely depend on your starting positions:

1. Quality Management System:

If the US company is already compliant with CFR 820, there are likely very little gaps to ISO 13485 and you can order immediately the audit of an NB for obtaining an EC-Certificate of your "complete quality Assurance System". The do it in two steps and make a pre-assessment of your readiness. Depending on the result of this assessment, the certification audit will be scheduled in a few weeks or month, giving you enough time for fixing gaps.
Please note that the primary requirement is an EC-Certificate, not ISO 13485. There are three directives for implantable MD, general MD and IVD. Identify the right directive and find the applicable pathway to CE declaration.
For the general MD directive 93/42/EEC, the most common pathway is annex II, which has almost the same QMS requirements than ISO 13485. You need an EN ISO 13485 version of the standard, which contains the annexes ZA, ZB and ZC explaining the gaps between ISO and the three directives. There are additional points on vigilance! If you obtain the EC-Certificate, you can request also issuing the ISO 13485 certificate (included in the audit scope).

1. Technical Documentation:

Annex I of 93/42/EEC lists up the "Basic Requirements" for MD and their documentation. You submit the Technical Documentation to your NB, they check it and if it is ok they list it up in the appendix of your EC-Certificate. Every MD needs its specific TD and entry in the certificate appendix. If your technical file is already following STED structure, it will be easier. A main point will be the gap analysis on applicable technical standards. The European Commission is publishing lists of current harmonized standards: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/index_en.htm
If you are not using harmonized standards, you need good reasoning for that.

It is not difficult if you know what to do. If you don't know you need a consultant, there are plenty in this community.

Bruce Youngman Very good information already provided.

Review 93/42/EEC and be aware that the EU medical device directive is currently undergoing revision. The Annexes are important as well as other regulations & standards incorporated by reference.

Determine the classification of the product. This is important in determining the level of work needed to declare conformity. For class 1 devices for example, retaining the services of a "Notified Body" is not required, there are Authorized Representatives that can hold the Technical File and provide for CE certification. Class II and above will require partnership with a Notified Body.

Marie Suetsugu NBs are under close scrutiny at the moment. I'd choose one of the top NBs, e.g. those involved in the MDSAP pilot, as I think they will most certainly survive (in our case we are a SaMD manufacturer so had a limited option, but we are happy that we changed from, say, one of the top 5-10 to one of the top 1-5).

Michael Wienholt, RAC Marie's point is a cogent one. Some NB's are not being re-certified to scope. It is crucial that you identify one that is competent to review products of your type. I suspect that at the end of this process there will be only a handful of NB's that will be capable of servicing the industry (e.g.; BSI, LNE/GMED, etc.), so the key is to start early in planning to comply with the pending new EU regulations.

Karen Boyd, ASQ CQA Careful Michael Wienholt, your examples of named NB's could be construed as advertising, and selective at that.

Michael Wienholt, RAC Hardly that, Karen. I challenge your assumption on the basis that the examples I cited are active participants in industry conferences and meetings that disseminate information broadly. They do their own advertising.

Julie Omohundro I would also caution against equating "re-certified" to "capable of servicing the industry."

If the number of NBs and scope of certifications is significantly reduced, then it will be the same old regulatory story. NB reviews and audits will start to backlog, just like FDA reviews and inspections have done over the years, when the responsibility is there, but not the resources. And then, when no one can meet the deadlines, they will be extended.

Michael Wienholt, RAC First - Directives are not undergoing revision. Two new Regulations will replace the three existing Directives. Both will change the way products may access the market in the EEA.

Second - If a NB is not re-certified, it cannot service the industry. Hence, my point regarding early planning.

Third - The basic question is flawed. Regulatory and quality compliance costs money.

Gottfried Griesmayr It is easy to find an accredited NB for your regulation on the "NANDO" website of the European Commission: http://ec.europa.eu/growth/tools-databases/nando/
go for "Legislation" and select the appropriate directive. For 93/42/EEC there are currently more than 60 listed. Further selection may go by country and recognized name, but most important look for the scope of the NB! Your product may be regulated by more than one directive and the NB must cover all of them. When clicking into an NB, you see the list of their accredited legislations and can dig for the details of your relevant directives.

Gottfried Griesmayr And if the budget is small, the final decision point may be the offer you get from the NB. Compare prices with services, there are significant differences. But I would not take "noname" NB's of certain countries....

Marie Suetsugu Dear Gottfried,
Yes, there are long lists of NBs at the moment, but my point was/is that they are expected to be shortened...

Julie Omohundro Michael, if you are referring to the original question, I don't see how it is flawed. It did not ask how to break into the EU for free, but simply how to do it with a small budget. If "small" is to be measured against an average budget of $32 million in regulatory-related costs for a 510(k), then, relatively speaking, one can get many devices on the market in the EU for a very small budget indeed.

Michael Wienholt, RAC Curious how you arrived at your figure of $32 million for a 510(k).

Michael Wienholt, RAC I think you linked to the wrong source.

Michael Wienholt, RAC Old data, and that report suffers from specific biases that were highlighted on page 19.

Julie Omohundro Michael, yes, I didn't present it as an accurate estimate of anything, but as the only standard I was aware of against which the concept of "small" budget might be defined. If you have a better source, especially one that defines "regulatory-related" costs, I'd be very happy to know about it.

In any case, my point was simply that I don't see how the question could be flawed, simply because regulatory and quality compliance cost money, when nothing in the question implied otherwise, and there was no indication of how much money "small" might represent.

Michael Wienholt, RAC Julie, the topic is so broad so as to preclude as "simple" answer. My basic point is that regardless of the markets one is trying to access, there are significant costs associated with regulatory and quality compliance. It is unproductive to enter the process with incorrect assumptions and biases.

Julie Omohundro Michael, here's the source. Looks like memory failed me last night, and it's $31 million in total development costs, of which $24 million is "regulatory-related":

http://advamed.org/res.download/3

Julie Omohundro Looks like I missed the last digit when I copied the URL:

http://advamed.org/res.download/30

Good question. Typically the next question would be "what is the ROI in my total investment to enter the EU market". Determining the total cost of entering a new market, the market size and your profit is essential. Regulatory costs are just one of the cost "barriers" however, this is only one side of the discussion.

Gottfried Griesmayr I do not understand the discussion about millions of regulatory costs. What is going into such calculation? The fees for the NB are about 0.1% of these figures, a few thousands you may spend for standard certificates and another few thousands for translations.
The translation costs for IFU's and safety information will be a decision point for entering a particular country. Although the CE mark is the basic ticket for 32 countries (28 EU + Norway, Iceland, Liechtenstein and Switzerland), all countries are requiring local language. But you can miss out small countries if their market size does not justify the translation costs.

Karen Boyd, ASQ CQA I agree with Gottfried, and don't understand how regulatory costs could accrue in the millions!

Marie Suetsugu This may be of interest to some:

Erik Vollebregt / BSI, 'The proposed EU regulations for medical and in vitro diagnostic devices, Updated' (October 2015)
http://www.bsigroup.com/Global/Med+Dev+WP/WP_EU-Regs-Updated.pdf
[see, for example, 'The changing role of notified bodies', pp. 2-3]

Julie Omohundro I'm pretty sure a lot of the answer lies in what was defined as "regulatory" costs, although I think there may be a significant amount of overspending of other people's money going on as well.

Tom Nonnemaker Valerie, I recently got a quote from emergo group for this, I am happy to share it with you. Send me a note to Tom@nvisionbiomed.com, or anyone else whose interested. It's a very good, thorough quote.