Not like US FDA, I don't think there's a database like that in Europe currently...

Ajax Thomas Some of the notified bodies maintain a searchable database of devices certified by them, but I don't think there is a central comprehensive directory accessible to the public for this purpose.

There is an initiative to setup a European Databank on Medical Devices(EUDAMED), but it is not publicly available as of now. You can get some info on the same here: http://ec.europa.eu/idabc/en/document/5362/5637.html

Fiona Dunlevy Thanks for the replies Paul and Ajax, much appreciated :)

Julie Omohundro No. The EU does not practice much in the way of transparency. It's my understanding that access to EUDAMED will be very restricted, unlike FDA's database, which is accessible to anyone.

No, I'm afraid there is no public list at the moment, and there won't be one in the near future.

CE marking is just the manufacturers way of marking equipment (and others) being conformative woth european directives. Theres no active agency checking up on equipment put on market, instead it's up to either manufacturer or importer to assure products are safe. Some CE-marked products are falsely labeled but most conforms with applicable directives such as MD, 61010-1/60402-1, PED, ISO standards, etc.

Try GMDN

Annika Fahlén Agree with Damian. The best indication of registered products is probably to review available GMDN codes

Eckhard Jokisch The new MDR defines in chapter 35 ff. that this EUDAMED shall be available to the public and even contain substantial information about clinical evaluation at least for class III devices. So that is clearly a step into more transparency.

Fabio Carmonini Each country should have its medical device database for the registered MDs in that country.

As an example, for MD registered to the local authority in Italy: http://www.salute.gov.it/interrogazioneDispositivi/RicercaDispositiviServlet?action=ACTION_MASCHERA

Eckhard Jokisch Fabio Carmonini that is exactly what the new MDR is *NOT* about. This is a purely European centralized database. We really need to learn from the past i.e. PIP and other reckless enterprises who endangered patients. Also MD companies need to learn that the regulations are a benefit for them.
Time for country specific deviations is over in Europe.

Adem Ünal titubb.titck.gov.tr Türkiye medical device database

Sathish Kumar I'm working in a small scale medical device manufacturing company and looking for CE mark were to approach and how much it cost. I'm from Bangalore, India.

Maurizio Colombo to Eckhard Jokisch: I believe Fabio was just pointing out the fact that Italy is to my knowledge the only country in the EU which makes available information about registered Medical Devices (although such information is very very limited). French MoH makes available on its website an Excel file with registered devices, but updates are not so frequent. However, I agree with you that there is the need for a centralized EU database overcoming the need for state-by-state registrations (see e.g. Italy, Spain, France, Belgium, etc.).
The answer to Fiona's question is unfortunately that there is no EU database publicly available, as others here have said. The only thing you can actually do is to try the Italian database or the French Excel file and hope to be lucky enough...

In France, on ansm website it is possible to find a list of all md on the french market but this list does not contain class I md. http://ansm.sante.fr/Activites/Mise-sur-le-marche-des-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMIA-DMDIV/DM-classes-IIa-IIb-III-et-DMIA-Communication-et-liste/(offset)/4

Fabio Carmonini Yes Maurizio, "should have" I meant that, up to now, in absence of a centralized european database, each country should have at least setup a national database.

We all really hope to have an european MD database soon.

Eckhard Jokisch to Maurizio Colombo: thanks for the clarification. I agree that at present there is no database and that is would be good if there was one - or had been one ;)
Actually with the new MDR there will be one and it will be available to the public.

Fiona Dunlevy Thanks everyone for all the input, I'll have a look at the Italian and French sources mentioned.

Julie Omohundro Maurizio, can you confirm my understanding the much touted "public access" to EUDAMED is not really going to be access by the public, but only by a limited number of entities, such as notified bodies, manufacturers, authorized representatives, and healthcare providers? I though I also saw something that suggested that access by these entities will be limited to specific information?

Adem Ünal http://titubb.titck.gov.tr/

Alan Farthing There is a public access database for UK Class I medical devices.
Not very user friendly.
http://aic.mhra.gov.uk/era/pdr.nsf/name?openpage&start=1&count=200

Maurizio Colombo To Julie: I looked at Article 27 of the new MDR draft and if everything remains as per the draft I believe that EUDAMED will become of public access in the future, since among the purposes of the database there will be to allow the users to be informed on Medical Devices on the market and on Clinical trials + allow traceability of devices. But that's a (near?) future. I believe we all hope this will become real within a short time, since a single database for all the EU will be of help to all Regulatory people round here.

Julie Omohundro Thanks, Maurizio. I will be interested to see how/when/if the MDR plays out.

Zoltán Kovács

https://cert.icrpolska.com/?s=2020-3010
On this site can you find the companies whos have a real and valid CE for protective mask.

Alba Marino

Hello, thank you for sharing this information. Does Germany have a repository similar to the Italian, French or British one? Thank you in advance.