Karen Boyd, ASQ CQA Likewise, Marcus! Many thanks. :)

Thobekile Nkala Thanks for sharing Marcus!

Ee Bin Liew Thank you, Marcus, for sharing once again. Much appreciated.

Cheers,
Ee Bin

I

Jenna Groves Great, thanks for the quick links!

Karthik Venkataraman handy info and links. txs for sharing

Thanks for sharing!

Thank you so much for sharing!

Thanks Marcus I have been searching for an update at least once a month.

Thank you for sharing, very helpful to try to stay ahead of the change

Ok Marcus, I liked your comment which is very helpful but forgot to thank you 😁
Many thanks for sharing this info. Regards, MJ

Duncan Dando Marcus,

Much appreciated and well timed as I am just starting to look at this development.

Duncan

Thanks Marcus

Webinar today and these pdfs are quite useful to say the least. Better to have a heads up now than a head knocked later for being 'clueless.'

William (Bill) Jackson Thanks and have not gone through the documents as yet, my weekend reading. I was just on line with the webinar entitled, "The Impact of New CE Marking Rules in Europe", by TUV . I WISH I HAD READ THESE BEFORE THE WEBINAR as the webinar was more the current approach plus at the end the difference proposals from the commission to the presidency. Other thoughts appreciated, keep these documents coming Marcus, kudos to you!!

Julie Omohundro I appreciate the links.

I personally try to ignore these legislative/regulatory dramas, which tend to drag on for years. Much of what people talked about and worried about and prepared for will often have changed by the time the drama comes to an end. And long lead times are invariably built into the process for compliance.

I prefer to stay focused on the laws and regulations currently applicable to the work on my desk, and let the drama play out. So I too am...well, still not just starting, but starting to think about how I will start...to look into the revisions, once the process actually comes to an end. I would be interested in attending a conference that covers the revisions in depth. I think this should take at least a full day, could easily run 2-3 days? If anyone has come across, or comes across, this type of opportunity, I (and no doubt others here) would be very interested in hearing about it.

Thanks Marcus, your post is really helpful.

Bill White The changes will be particularly challenging for IVD companies. An IVD company that waits until the last minute before addressing the changes will be quite sorry.

Hi guys
You who are working with regulatory, are you not afraid that the costs for regulatory, in a project, will reach the limit for what a company are prepared to pay for a new product. When I made my first implant in the 1980th I phoned the Swedish authorities on Läkemedelsverket and asked what rules I had to follow, the answer was: Call us back when you are ready and tell us. Of course that is bad, we do need to protect the patient, but when I give a quotation to a customer today for a class III product, the regulatory is about 40% of the total sum. (Plus costs) This is a little scary for me as MedTech development expert. Will the companies go on making new products to benefit patients, especially the small and new once? Will this stop the creativity for new inventive products to reach the market? I think we have a critical balance here, I have had customers saying no thank you depending of those costs. Can we solve this problem, so it benefits all categories involved?
What’s your opinion about this?
Robert

Marrianne McGhee RN BN MaEd Great share Marcus.

Robert Axelsson, I just listened to the presentation by Bassil Akra of TUV SUD, and it is seems clear to me that if a company studies the requirements and then the options carefully, that for many products, a less intensive review process might be possible.

If a company properly describes what they are doing which classifies the product as similar to what competitor products exist, then a company can file as an equivalent product with a lower amount of work to do to get clearance.

If the comparison to the 'old' cleared product vs the 'new' product has the "same intended use", "technical equivalence", "biological equivalence", "difference regarding safety" and "difference regarding performance", then the requirements to be met are far lower than if the company submitting for approval claims 'new, unique, etc.'

Obviously a class I or II product will have less stringent needs for consideration.

In the end, a very good analysis of the competitors in the field needs to be undertaken to know whether a new product will face the harsher scrutiny required of a truly unique, cutting edge product.

Julie Omohundro Robert A, that is a great question, but goes well beyond the scope of this discussion, I think. I dare you to post it as a separate discussion. :) As a starting point, I would love to see a list of what people consider to be "regulatory" and "non-regulatory" costs.

In a mere comment, I will say that, when start-ups come to me and ask about regulatory timeframes and costs, my reply is always, "Trust me, regulatory is the least of your worries." So far, no one has ever looked back and said I was wrong about that. There is nothing much to say about 40% of Class III development cost being "regulatory" costs, without more details.

In the US, "regulatory" costs are the filing fee, plus my time as the regulatory expert. I can't imagine a Class III so simple to develop that the development costs would run a mere 60% of filing fee + my time. Perhaps I should raise my rates. A lot. :)

I have several theories as to why companies think their regulatory costs are so much higher than is at all rational, really. Pursuing this issue is on my to-do list for next year. Will let you know what I find out.

Oh, and to answer your question directly, no, not a bit worried about the regulatory costs. If you are a regulatory professional in the US, it would be a welcome relief to hear various parties here complaining about the high regulatory costs in the EU, rather than the decades-old refrain of "FDA is stifling innovation."

Julie Omohundro Arithmetically challenged...60% of the total cost, where the filing fee and my time are the other 40%.

zain malik beacacuse we are working on regulatory in surgical instrument

zain malik dear robert i m very happy to see here on linkedin if any body work regulatory in any products its regulatory cost 60% to 65% if you are interesting you now about regulatory cost so contact us
feel free at www.punctualsurgical.com
info@punctualsurgical.com

These are just the Council versions. The European Parliament and the Commission have their own views. The final versions will be compromises between the three sets of views.

Julie Omohundro Mika, thanks. Are you aware of a website where someone is keeping track of the progress in an easy to check format? I have been looking for one that lists all the steps in the process and then is logging the date of each one as it occurs? The EC's website is not easy to follow, at least not for me. Otherwise, what I find are "timelines," rather than milestone trackers, with more of a focus on predicting the future than tracking progress in real time.