Medical Device Registrations in Europe - Regulatory Affairs of Medical Devices

[PPcricket]

Hello....I have a quick question related to the regulatory affairs of medical devices.

Once you have your product CE marked, to sell your products into Europe, are there specific country requirements in terms of registration and notification to the relevant country authorities, or can products be sold without any further notifications in the EU.

Many thanks, P

 

[Marcelo]

Re: Medical Device Registrations in Europe

There are national requirements.

I have some compilations which came in the RAPS EU book, but I don´t know if there´s one place to look for them on the net (if there is, can someone please share?), but you could also look at the websites of each country competent authority.

Regarding notifications, the directives have requirements for post-market surveillance and vigilance. You can also take a look at some MEDDEVs (http://ec.europa.eu/enterprise/medical_devices/meddev/meddev_index_en.htm) and NB-MEDS (http://www.team-nb.org/index.php?option=com_docman&task=cat_view&gid=22&Itemid=38)

 

[somashekar]

Re: Medical Device Registrations in Europe

There are national requirements.

I have some compilations which came in the RAPS EU book, but I don´t know if there´s one place to look for them on the net (if there is, can someone please share?), but you could also look at the websites of each country competent authority.

Regarding notifications, the directives have requirements for post-market surveillance and vigilance. You can also take a look at some MEDDEVs (http://ec.europa.eu/enterprise/medical_devices/meddev/meddev_index_en.htm) and NB-MEDS (http://www.team-nb.org/index.php?option=com_docman&task=cat_view&gid=22&Itemid=38)

Also one must note that EU members have various language requirements specific to the country and medical device classification. The IFU / Manual / other informations must respect this. During the CE mark process you would have made a commitment towards respecting the language requirements.

 

[Marcelo]

Re: Medical Device Registrations in Europe

Just remembered another point, depending on your product, there even might be other applicable directives. For example, for consumer products, the general product safety directive might also apply (Directive 2001/95/EC on General Product Safety).

 

[Rocke]

Re: Medical Device Registrations in Europe

Hello....I have a quick question related to the regulatory affairs of medical devices.

Once you have your product CE marked, to sell your products into Europe, are there specific country requirements in terms of registration and notification to the relevant country authorities, or can products be sold without any further notifications in the EU.

Many thanks, P

Hi P,

Yes, you need to notify the competent authority in each member country, where you are placing the product on the market.
A list of contact information is available here: http://ec.europa.eu/enterprise/medical_devices/ca/list_ca.htm

Note that the EU Commission is considering, within its proposal package for the compulsatory implementation of EUDAMED, the deadline of 1st May 2011 as the end of the transition period for the notifications under article 10.6 of the IVDD (I do not know the relevant article in the MDD).
So hopefully, by May 1st 2011 you will only need your European representative (I am assuming you are located outside the EU) to inform the authorities in their own country of new products or product changes. The national CA will update the EUDAMED database and the information will be available to all European countries.

Best regards
Camilla

 

[SilverHawk]

Re: Medical Device Registrations in Europe

For those non-European manufacturers who wish to list and place their products in EU and looking to appoint an Authorised European Representative, I would recommended this one as follows :-

Mr. Doram Elkayam
Obelis S.A.
Belgium
Tel : +32(0)2 7325954
Fax: +32(0)2 7326003
Mobile: +32(0) 473 490130
Email : Deleted by Moderator

 

[yana prus]

Re: Medical Device Registrations in Europe

Regarding the various language requirements specific to the country and device - professional use vs. non-professional - here you can find the specific requirements of the EC countries:

http://www.team-nb.org/Documents/MD...ements_for_Medical_Devices_update_Sept.08.doc

You can add this doc to the list of the applicable standards/documents or just mention it in the Translation procedure.

The Italian Ministry of Health has introduced registration procedures for medical devices in Italy. All medical devices introduced in Italy after May 1, 2007 must be registered according to the procedures before medical devices can be sold in Italy.

 

[Watchwait]

Re: Medical Device Registrations in Europe

Following the last post regarding language requirements, the matrix provided by Yana was helpful. However, we are always faced with making a more detailed decision regarding labeling as it pertains to medical devices in the EU. We produce a device that has language issues in the following areas:

1. Physical labels attached to the product.
2. Printed material accompanying, but not attached to the product.
3. An electronic Users Manual embedded in the product software.
4. A keyboard
5. A graphic user interface (GUI)

The requirements for items 1 & 2 is typically straightforward. They either require printing in the native language - or they do not. Item 3 could fall into this same class. Item 4 becomes a bit less clear. Is it acceptable to provide an English keyboard when the users manual is in the native language? Most challenging is item #5 - the user interface, as it requires the most customized software. But again, we are not complaining about having to do the work, if in fact it is REQUIRED by the target country. The problem we (I) have is finding clear, documented requirements that speak to these issues. Even our Notified Body, when asked directly cannot cite applicable rereferences for this information. Any takers here...??

 

[scamden]

Re: Medical Device Registrations in Europe

Since this discussion has to do with MDD, I figured I would solicit some help here as well - I am conducting a research initiative on the expected impact of the amendments to the EU's MDD (MDD 2007/47/EC or M5) and am hoping that some of you might take a few minutes to take my brief survey. It is 14 questions, and no longer than 5 minutes to complete - I will be publishing the results in an industry journal, and will also publish a white paper for industry colleagues as a thank-you for their participation in this initiative - if you have a few seconds and could help me out, I would greatly appreciate it! Here is the address where you can locate the survey (won't let me post a regular link - I am hoping any that read this can assume that I am missing the www part of the address: maetrics.com/news_events/maetrics-initiates-research-study-on-mdd-2007

Many thanks!
Sara Camden

 

[MarkinCalifornia]

Re: Medical Device Registrations in Europe

I have the exact same questions as Watchwait. I would certainly appreciate if anyone has any guidance that they can provide, particularly with regard to #5 (i.e., the need for the GUI to be in the national language(s) of the target country. Thanks