G M Butcher start here - http://www.iaf.nu/articles/Accreditation_Body_Members_by_Name/52 and drll down thru the country of interest to the certification bodies. Many operate internationally, so it is not totally necessary to have one with offices in the country of interest, unless required.

Avital Arbel thank you very much. i'll try that.

Ruud Lans It' s depends in the country the NB is active as the national authority accreditation organisation is certificying the scope. The accredited NB you can find e.g. in the Nerherlands at www.rva.nl

Yi Grace Lin May need to search individual organisation listed under an Accreditation Body in the country of interest.

TUV is accredited, I am using them for my cert this year.

Maya Siboni Melamed If you will need to be certified also in Canada use one that is approved also by health Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/quality-systems-13485/list-registrars-recognized-under-section-32-1-medical-devices-regulations.html?_ga=2.221202779.27025148.1508870760-1714987438.1508870760

Tina Krenc, M.S. http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.pdf&refe_cd=93%2F42%2FEEC&requesttimeout=900



This is a listed published 10/23

Konrad Kobel If you enter a search in Google you will be provided with a link to all NBs for the medical device directive. Just enter "list of accredited notified bodies for medical devices"

Interrek

Ian Hendra Don't waste your time with certification to it yet because ISO 13485:2016:

1. Isn't harmonized in the EU. 13485 has never been called up in 93/42 EEC the MDD and it's not in the new MDRs. The harmonised version is still EN ISO 13485:2012 if you insist on wasting money on CB fees, but it's conformity with the conformity Annexes that counts (and they're easier),
2. It is not a FDA consensus standard, ISO 13485 has never been! 21 CFR-820 still rules supreme. Once again, save the certification fees.
3. MDSAP hits for Canada as of the end of next year but cert'n to 13485:2016 doesn't count as its only a part of the MDSAP scope. MDSAP is expensive so understand the business case for doing it. Having said that.
4. MDSAP will count for routine FDA inspections (which are free anyway), and for registration in Canada, Japan, Brazil, and Australia.

All you need to know to set for MDSAP is here:
https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/ucm377580.htm

For the UK, the MHRA lists them. see https://www.gov.uk/government/publications/medical-devices-uk-notified-bodies/uk-notified-bodies-for-medical-devices. Hope this helps.

Karl-Heinz Spohn in data bases like DAkkS https://www.dakks.de/en/content/accredited-bodies-dakks
you can select according ISO/TEC 17021-1, Management Systems and then T16 => 13485. Here you'll find if the NB already is accredited to 2016

EN ISO 13485:2016 may be found on the list of harmonised standards at https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en. On 2017-11-17 as PROSYSTEM announced this in German on 2017-12-06 in an email http://mailing.prosystem-ag.com/m/6964546/502073-1afe3daa0f52cd7a4c3341b81377aa91.

Olivier Zarza Interesting points Ian, although from an EU point of view 1) EN ISO 13485:2016 is on the harmonised standard list since november 17th, 2) there is a high probability that customers in EU will require (for public tenders) MD companies to be certified as per this version and 3) MDSAP is not recognized in EU (for better or worse ...).

Patricia Medina Avital, if you go to the EU MDD main web site you will find a link to a list of approved notified bodies. Some nb on the list have adjusted thier scope but it is a through list with contact information. i found it very helpful.

ISO 13485:2016 was harmonized and published in the EU OJ in November 17, 2017

The international organization managing ISO 13485 accreditation schemes is the IAF (http://www.iaf.nu). There you can look up the list of Members and Signatories to find out about the national accreditation bodies. For the UK this is UKAS. On their website you can search for QMS certification bodies to find out about any ISO 13485 accreditations. Most of these national accreditation bodies websites will show the result you are looking for on "ISO 13485:2016" as serch term.
I'm not aware of any database to lock up any combined result of Organizations accredited as Notified Body for EU-regulations and other accreditations.

Ivan Liljegren ISO 13485:2016 was just published as a harmonized standard in the EU official journal, so all device manufacturers CE-marking with a notified body will have to adopt it. As regards who can do the job, best way is to ask them. Use the EU NANDO list as basis to figure out who supports your product codes. And remember to ask about their MDR transition...

Ian Hendra Olivier Zarza CE Marking in the EU is the criterion that establishes the right of free trade between Member States under the MDD now and the new MDRs in due course. I am familiar with technical specifications for manny items of diagnostic imaging equipment. I cannot recall a single one that calls up ISO 13485 yet they all call their CE Marking and product classification. Hence, IMHO, ISO 13485 certification is a scam in the EU as it is not necessary.

In any case it's scope is for regulatory use so it's up to regulators call it up, it is not a purchasing standard to be called by purchasers. I know of no medical device regulations that call up customer satisfaction as a criterion to be met. ISO 9001 ihas been the standard for that purpose since 1987 as were it's predecessors for the 20 years previously.

ISO 9001's scope deals with customer satisfaction. From the point of view of a wise purchaser, ISO 13485 is ISO 9001 with the customer satisfaction elements removed, so it is useless in that role.