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Medical Devices Questions and Answers

Question

I have a question regarding a medical device study in Germany.

In Germany the act on medical devices (medizinproduktegesetz - MPG) states in paragraph 23:
"Exceptions to the provisions governing clinical investigations. The provisions contained in section 20 and 21 shall not apply where the clinical investigation is conducted using devices which are authorised in accordance with section 6 and 10 to bear CE marking, unless the aim of the investigation is to use the device for a different intended purpose or additional invasive or other stressful examinations are to be carried out".

As a result for example no Ethics commission submission and approval is necesarry.

I am now involved in a medical device study in Germany and according to the Clinical Investigation Plan ISO14155:2011, Declaration of Helsinki, Medical Device directory 2007/47/EC and Medizinproduktegesetz - MPG are applicable.
MPG is contradictory to the other regulations for example regarding Ethics Committee submission and approval. My question is what regulation prevails because it is impossible to comply to all referred regulations since they are contradictory.

Answer

For every study (data collection) you do, Ethics Committee approval is needed and thus some sort of protocol is required. Whether or not ISO14155 compliance is needed for the protocol is based on the folowing:

If you do a study with a non-CE marked device in Germany, you need to obtain both Ethics Committee approval and BfArM approval. These studies are mostly done for regulatory purposes and shouls comply with ISO14155.

If you do a study with a CE-marked device outside it's intended use, you need to obtain both Ethics Committee and BfArM approval. These studies are mostly done for regulatory purposes (expansion of the labelling) and should comply with ISO14155. Exception would be small feasability studies which data you would not wish to use for regulatory submission. There you would only claim compliance with the Declaration of Helsinki, but not with ISO14155.

If you do a study with a CE-marked device and collect data that are outside standard of care (an interventional post-market study), you also need to acquire both Ethics Committee approval and BfArM approval. Depending on what you need the data for, you can choose whether or not you would like to follow ISO14155. If you need the data for regulatory submissions, we would advise to do so.

If you do a study with a CE-marked device and only collect data that are within standard of care (often called a registry or observational study), you only need to obtain Ethics Committee approval. These studies usually do not follow ISO14155.

For every study, you follow the Declaration of Helsinki.