German Safety Officer for Medical Devices for a UK based Company?

Does anyone have experience with appointing a safety officer for medical devices in Germany?

article 30 of their local regulations state that:

The person responsible according to § 5, sentences 1 and 2 and who has his/her registered place of business in Germany shall, immediately upon commencement of his/her activities, appoint a person who is sufficiently reliable and possesses the expert knowledge necessary for the fulfilment of his/her functions as the safety officer for medical devices

Click to expand...

My concern is that it states "AND has his/her registered place of business in Germany".......We are not based in Germany

Is the safety officer supposed to be from the original manufacturer in the UK or is he/she supposed to be a person at our local distributor in Germany?

pkost said:

Does anyone have experience with appointing a safety officer for medical devices in Germany?

article 30 of their local regulations state that:


My concern is that it states "AND has his/her registered place of business in Germany".......We are not based in Germany

Is the safety officer supposed to be from the original manufacturer in the UK or is he/she supposed to be a person at our local distributor in Germany?

Click to expand...

Hi,

If you could please share the text of the above section 5, it might help!...

Cheers,
Ronen.

Hi pkost,

I think this is a classical translation error. The section of the law you cited says, that a manufacturer, who is located in Germany has to nominate a safety officer. This is unique for the German system. All companies who use CE-marking and are not located in Germany do not need such a safety officer to sell medical devices in Germany. In your case it depends on the address shown on the label. Who is the "manufacturer" of the product? Your company in the UK or the distributor in Germany?

Regard

phloQS

Ronen: Here is an english translation of the german law: http://www.bfarm.de/cae/servlet/contentblob/1016272/publicationFile/65770/MPG_en.pdf

phloQS - thanks for your response, I had suspected an issue with translation, but seeing as I only speak very limited German I couldn't confirm

To confuse matters our distributor has been told by DIMDI that they need a safety officer - do you know if this is the case?

It strikes me as rather odd that a distributor would require someone to coordinate/manage vigilance/recalls when those issues are the responsibility of the manufacturer.

We (a UK company) are identified as the manufacturer on the device


edit: If the safety officer is limited to countries in Germany, the act seems to suggest companies outside of the EU are required to appoint someone via probably their EC rep. There are also consultancy companies that offer a safety officer service to companies?

Hi pkost,

Are your products registred at DIMDI by your distributor? I can not understand why your distributor has any contacts to DIMDI. They normally do not need to be registred, as they are only distributors. They can not give information needed for registration, such as Certificate number for 13485 and the Annex II or V certificate for the products, as they do not have one. As a european manufacturer YOU are the responsible person for the product as you already pointed out. Maybe there was a misunderstanding between DIMDI and your distributor. Did your distributor tell DIMDI that YOU (UK-Company under UK- address) are the manufacturer outlined on the product? There are many consultants that spread offers as safety officers for local german manufacturers, because there are many small companies, who do not want to do this job on their own. You need education and knowledge. This is sometimes very hard for companies. This is why there are such offers. The EC-Rep is just for companies, who do not have their origin in europe.

Regards

phloQS

Could it be that the distributor is a subsidiary of ours?

Is it an own in germany or UK registred company (Like GmbH or ltd)? Then this should not be a problem. Also if it is just an office there should be no problem. The european adress of the manucaturer is the thing what counts. As I told before, how do you wanna be registred in Germany? And if you are not registred in Germany you have no possibility to register a safety officer.

regards phloQS