Tilo Borchardt As far as I know the EU has not yet adopted the STED. But if your technical file covers all items required by STED you should not have problems with CE (assuming the particular documents are sufficient).

Kanika Bansal Thank you Tilo for the response. Do you have any link or more information I can read through on STED?

Stephane Morvan Kanika: I can also recommend STED as the basis for your technical file.

STED merely covers the organization of your technical/master file for medical devices. It is not so much about the content, but rather about the structure of your technical files.

Down the road, when you seek regulatory approval outside of the EU, you should find that having your master file organized according to STED will make your life a whole lot easier, as more and more regulatory agencies are asking for specific sections of STED files...

For more information on STED:

http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n011-2008-principles-safety-performance-medical-devices-080221.pdf

If I were you, I would consider hiring someone with expertise to help you ensure you do the right choices while creating your master file. Small mistakes are costly to fix later on.

I'm building a Technical File using the IMDRF format. It's document IMDRF/RPS WG/N9FINAL:2014 on http://www.imdrf.org/documents/documents.asp. I don't know yet whether Regulators and NoBos will welcome it but it is a useful checklist for what to include.

Floris Boele STED is the routing document to guide you through the CE marking technical file process. If you follow that STED document it becomes easier to obtain the Ce marking. Outside of the EU it is helpful to obtain other licenses as well is my experience.

Dear Kanika,
from my personnel experience I can strongly recommend building your technical file according to STED or as mentioned above according to the new structure introduced by IMDRF.
A structured file respectively same structured files over all your device families can save a lot of time for you and the reviewer at any certification body/authorization etc. worldwide, not only EU.
But having said this, at the end the content counts. It must be logical without contradictory information and without circle references. But a clear structure helps to find those stumbling blocks.

Kinaka,
Another reason to choose for STED is that the upcoming new EU Regulation about Medical Devices will also refers to STED as the standard for your Technical Documentation.
Following STED you'll be prepared for the future.

http://www.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2012/0266%28COD%29

Kanika Bansal Thank you everyone for your advice. The links you sent had been very useful.

Kanika Bansal Also, any idea about trial size needed under STED? If I do my trials in EU, will it be considered valid when going for FDA approval? Or do I have to do trials again in US?

FDA has a guidance note: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm124939.pdf

As for trial size, these are often specified if you are complying with an international standard. If not, you'll need a robust statistical argument to justify the trial size.

I echo the earlier comment that it is worth retaining a good regulatory consultant. I've used an excellent small company in the USA who helped us a long way with FDA and we also retain a European company to help us with regulation and with building our QMS. Send me an email on cje@leman-micro.com and I'll give you the details.

Kanika Bansal Thank you Chris. I have emailed you. Your help is highly appreciated.

Stephane Morvan @Kanika: if the FDA approves your trial protocol beforehand (they have *very* specific demands), you might be able to get your CE Trials taken into account to gain FDA approval.

However, FDA being a beast of its own (which used to change its mind quite often), please enlist the help of specialists on this topic to help you navigate properly.

Interesting discussion. We have started Modular Operation Theatre design, fabrication and installation business and intend to go in for CE mark initially and USFDA subsequently for all products that go in for making an MOT. I will be following this discussion keenly.

Kanika Bansal Stephane Morvan: Thank you for the information. I will make sure my protocols match FDA. Hopefully that can help me get approvals faster.