EU Country Specific Medical Device Registration Requirements

[RAspecialist]

HI

We have both Class I and Class IIb medical devices which are CE marked. We would like to launch into:

• Germany
• Belgium
• Italy
• France

I am therefore wondering what the country specific registration/ notification procedures are in order to sell into those markets?

I have met all the translation requirements.

Can anyone help?

Thank you

[SteveK]

Strictly speaking, if you have registered the Class I devices with the MHRA (self certification) and your Class IIb devices though your notified body – that should be it for the EU market. CE marking should allow free movement throughout the EU i.e. from article 14 of MDD:

Any manufacturer who, under his own name, places devices on the market in accordance with the procedures referred to in Article 11 (5) and (6) and any other natural or legal person engaged in the activities referred to in Article 12 shall inform the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business and the description of the devices concerned.

However, the Italians have put in an extra layer in the process see thread:

Italian Ministry of Health Medical Device Databank regulation

Steve

[bio_subbu]

In Reply to Parent Post by RAspecialist

HI

We have both Class I and Class IIb medical devices which are CE marked. We would like to launch into:

• Germany
• Belgium
• Italy
• France

I am therefore wondering what the country specific registration/ notification procedures are in order to sell into those markets?

I have met all the translation requirements.

Can anyone help?

Thank you

You may want to contact the competent authority of the each member state where the product is marketed (eg, Germany, Belgium, Italy, France). Normally, the product registration can be done through manufacturers with registered office in member states or authorized representative or distributors. A list of contact points (PDF version) for medical devices national competent authorities can be found here.

[MIREGMGR]

In Reply to Parent Post by bio_subbu

You may want to contact the competent authority of the each member state where the product is marketed (eg, Germany, Belgium, Italy, France).

As SteveK notes above, this is neither necessary nor desirable except for the Italy situation.

[Burgmeister]

In Reply to Parent Post by MIREGMGR

As SteveK notes above, this is neither necessary nor desirable except for the Italy situation.

Sorry, for my slowness here, but are you saying that if your (in our case Class IIb) device is CE marked in the UK, you do not need to register at all with the French authorities before marketing there? I know that the EU is supposed to offer free trade and movement of goods, but in addition to the Italian situation, I know that registration is required in Portugal and Spain which makes a bit of a mockery of the whole thing ( I appreciate that the OP made no mention of Spain and Portugal but I was using them as examples of where registration is required in the EU).

Thanks

[pkost]

As previously stated, there is no need to notify any of the CA's if you have already gained a CE mark through your local NB (in case of class II) and your local CA (MHRA) (in the case of class I). Italy is the only exception as they require registration of all devices to sell into their healthcare system.

We sell into Spain and have not had to register there either - what do you mean by having to register for spain and portugal?

[Burgmeister]

In Reply to Parent Post by pkost

As previously stated, there is no need to notify any of the CA's if you have already gained a CE mark through your local NB (in case of class II) and your local CA (MHRA) (in the case of class I). Italy is the only exception as they require registration of all devices to sell into their healthcare system.

We sell into Spain and have not had to register there either - what do you mean by having to register for spain and portugal?

OK, may have been mistaken about Portugal, but I'm not certain. For Spain, however, we definitely had to provide a CE certificate and list of products we wished to market. This was done through our Spanish distributor so not sure of the exact address to which this was sent or whether she filled in any other 'registration form'.

Edit: I have just looked out the email from our Spanish Distributors and this was their requirement:

In order to register your products with the Health Authorities, could you please be so kind to send me as soon as possible the following information?:

1. GMDN (Global Medical Device Nomenclature) of all the products.
2. Latex Free Certificate.
3. Product classification (Whether the product belongs to Class III, IIb, IIa or I), including all instrumentation.
4. Labels with the CE Mark, from the unit packaging and the protective packaging (Implants and instruments).
5. Insert or instruction manual (IFU) with the CE Mark.
6. If the product belongs to class III, the design certificate should also be included.
7. Declaration of Conformity for the Implants and the Instruments (With a complete list of all the references and descriptions).
8. EC Certificate.
9. ISO Certificate.

Thanking in advance your assistance.

[PaulGr]

A recent article in the MPO also indicated registration requirements for Spain:
http://www.mpo-mag.com/articles/2011...opean-vacation

I am still believing that these registrations are only for reimbursing purposes and that just the sales is allowed by CE as explained by SteveK.

If my view is wrong, I would appreciate if someone could clarify on this.

Cheers, Paul