MDR: The marketing and post-market surveillance phases (5/6)
(See previous article)
Once the registration of the medical device has been completed on the manufacturer’s side, the authorised representative and/or the importer will proceed with the registration on their sides provided they receive from the manufacturer all necessary documents translated in the language of the European country where the device is to be distributed.
If the manufacturer has a website, any safety and performance information relevant to the user or any other person (IFU, identification…), has to be made available on it, and kept up to date in the language of the country in which the device is made available. (Annex I, 23(1))
Once the device has been officially placed on the market, the manufacturer will have to maintain the risk management system that has been set up as part of the quality management system described in Article 10(9) of the MDR.
The risk management system is based on the post-market surveillance plan which for devices other than custom-made devices, is part of the technical documentation specified in Annex II.
The purpose of this system is to actively and systematically gather, record and analyse relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to draw the necessary conclusions followed by implementation and monitoring of preventive and corrective actions. (Article 83(2))
It implies drafting, according to the classification of the device, a Post-market surveillance report (class I) or a Periodic Safety Update Report (class IIa, IIb and class III) based on all the post-market surveillance data that has been gathered.
The post-market surveillance plan addresses as well the Post-Market Clinical Follow-up (Annex XIV) which implies continuous collection and evaluation of clinical data on the use of the device. The results are to be documented in a Post-market clinical follow-up evaluation report.
Depending on the classification of the device, these reports will need to be updated every year or every second year. Every change made to a document will imply updating corresponding data in the technical files and in any other related document.
Working with the same Language Service Provider seems to be the most adequate solution to guarantee content consistency in a large volume of multi-lingual files prone to regular updates.
Contact us today to discuss how Baguette can best help you work it all out.