Medical device manufacturers face a lot of efforts caring about the information of the product design, test and production. Such information must be available in a human readable format at least 10 years after the last product was put on the market (15 years for implantable products). If a medical device manufacturer or even the European authorized representative stops its business for any reason the obligation to have information available is still valid and availability of product information to notified bodies must be ensured. Especially information about clinical trials may cause problems if the pseudonymized personal data and the information to convert the pseudonyms back to clear names are stored in the same place.
Laws like the German “Medizinprodukte-Durchführungsgesetz” (MPDG §5) allow the government offices to determine how information has to be stored as well as which information has to be stored in dependency of the role (sponsor, manufacturer, representative). As there is no dedicated platform to store such information long term it makes totally sense to check if cloud solutions might fit your purposes and to get in contact with your respective government office in order to clarify, if they support the approach you have in mind.
One detail may be of interest in addition, especially for clinical data. As soon as all information will be managed on one platform the risk of re-identification of personal data may rise if encryption keys or re-identification lists for pseudonyms become available for similar user groups. It makes sense to find a solution which enables you to keep this information separate or with different permissions in order to ensure that personal data does not become identifiable. Such a storage solution must at least be valid and capable for the next 10 to 15 years ((EU) 2017/745 Annex XI Part A Section 9 and 10.5 as well as Annex XV Chapter III nb. 3 of the regulation for sponsors of clinical investigations and for (EU) 2017/746 Annex XI section 6 as well as Annex XV Chapter II nb. 3 for sponsors of (clinical) performance studies).
In summary discontinuance of business might have different reasons but the accountabilities in regards to product information still remain according to the regulation timelines. In addition, potential personal data of clinical studies must be stored in a way that still ensures its anonymity/pseudonymity up to 10 (15) years in advance.
Written by Roland Schnitter, Senior Consultant
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