Jonathan Phillips Once you have registered a class I device with the MHRA and the details are on EUDAMED then I believe you are good to go in Germany. (There may however be some local registration requirements). In Portugal and Spain on the other hand!

Marco CATANOSSI Class I must be registered only in one country, for higher class may be necessary multiple registration, but it's up to national regulation. In Italy and Spain fir instance it's this way. If the product is electric, you need to apply to national organisations for electrical waste management. The same if it contains batteries. If you don't , the importer is responsible for it.
Of course you need to translate into German the labels am IFU.
Hope this help.
Marco

Marco CATANOSSI Ps. I meant in Italy and Spain is necessary to register higher class of MD also if they are already registered in other EU countries.

Marcus Gould Hi David

There are a number of additional requirements, and these depend upon a number of factors. Could you let me know the following and I can help.

* You say the product is MHRA registered. I am assuming this means it has been notified, because its a Class I, to the MHRA? Was this done by the legal manufacturer or an Authorised Representative?

* Will you be placing the device on the German market using an importer? Is the legal manufacturer outside the EU/EEA? The person responsible for placing it on the market needs to be affixed to the IFU, labels etc? This could be the legal manufacturer, Authorised Rep, or importer.

* Is the device an electronic or electrical equipment as defined by Directive 2011/65/ EU? If so, have you affixed the CE mark to comply with this directive?

* As Marco identified, if the product is electronic or electrical equipment it will need to be disposed off as WEEE? If so, have you implemented a disposal system or signed up with a WEEE compliance scheme?

* There may be a need to appoint a safety officer and have this informed to Bfarm (German competent authority). This will depend on the answers given to question 2.

Thanks,

Marcus

Dear David
I assume you want to sell the product shown on your webpage and that your Company is the legal manufacturer of the product.
As your company is located in the UK and the product is already registered to the MHRA, there is no need to do an additional notification to the German competent authorities.
The need to appoint an safety officer according MPG §30 (German Medical Device Act) is only relevant for German legal manufactures or authorised representatives with a registered place in Germany.
The HWG is also relevant for medical devices, so this means that your advertising and marketing should be in compliance to this law.

You should check if a reimbursement is possible. The health insurance system in Germany is different to the UK.
Reimbursement would be possible if you are listed in the "Medical Aids List"(Heilmittelverzeichnis). Not every product can be listed and not every product falls under the reimbursementsystem. A research might become neccessary.

The need to translate the IFU and the label into German language is a requirement in the MPG §11

I hope this helps.

Clemens