CE Class I Medical Devices (Instruments) - Germany Registrations

[QA-RA Jones]

All:

I apologize ahead of time if this discussion already exists....

I am looking to self-declare a handful of Class I (non-sterile and non-measurement) Medical Devices (Instruments) in the EU. We have an authorized rep, however I was not involved in the agreement and they don't really do that much for us in regards to the actual registration process. We also have an NB that we have registered a variety of higher class instruments and implants through.

I am trying to figure out how to register my Class I devices in Germany (or if I even need to). Once the Technical File is built and the Essential Requirements accounted for, how can I make sure that my products are ready for sale in this particular Member State. Do I have to submit a list and brief description to the Competent Authority (CA) of all of these Instruments (as identified in the MDD 93/42/EC)? Also, if the list gets updated with more Class I instruments do I submit a new list each time this occurs?

Also, are there any fees associated with registration (other than what we pay to the authorized rep)?

Any specific help that can be offered would be greatly appreciated.

Thank you for your input.

Side Note: If we wanted to branch out from Germany in the future, do most of the Member States require registration in each region individually (i.e. submit this list to each CA that we would like to sell under)?

 

[Ronen E]

Hi,

I am trying to figure out how to register my Class I devices in Germany (or if I even need to).

AFAIK Germany is not one of the member states that require special national registration on top of the one required by the MDD. The registration required by the MDD needs only to occur once for the entire EU - with the Competent Authority of the Member State where the Authorized Representative has their registered place of business. Your AR should register your devices - if they don't, they're useless as an AR and you should look for another.

Once the Technical File is built and the Essential Requirements accounted for, how can I make sure that my products are ready for sale in this particular Member State.

Once you have complied with all the applicable requirements listed in the MDD for non-sterile non-measuring class I devices (including in particular annex I - Essential Requirements, and annex VII - Declaration of Conformity / Technical File), your devices will be ready for marketing in Germany.

Do I have to submit a list and brief description to the Competent Authority (CA) of all of these Instruments (as identified in the MDD 93/42/EC)?

Yes, but only once for complying with the MDD. If your AR has their registered place of business in Germany, they would register with the German CA. Otherwise, they will register in their own Member State, and registration with the German CA will not be required.

if the list gets updated with more Class I instruments do I submit a new list each time this occurs?

You only have to register (notify the CA) once for each device you start placing on the market, but it might not be a bad idea to resubmit the entire list at such occasions, to reaffirm that all previously notified devices are still active (have not been discontinued). Just make sure to separate existing devices from new ones so you don't unnecessarily burden whoever will have to process it.

are there any fees associated with registration (other than what we pay to the authorized rep)?

There might be an administrative fee - best check with your AR, regarding the CA in their member state.

If we wanted to branch out from Germany in the future, do most of the Member States require registration in each region individually (i.e. submit this list to each CA that we would like to sell under)?

There are several Member States that require their own special registration, e.g. Italy and Spain. Definitely not most of them. I don't have a comprehensive updated list, but there have been threads in Elsmar discussing some. If you run a thread search with the state of interest as the search term, you might find some relevant info.

Cheers,
Ronen.