MDR, IVDR, re-cert ISO 13485

Category: contract law, product safety, compliance Industry: healthcare Author: Year:

Medical device manufacturers to face challenges in 2019 too!

In 2018, an initial course was plotted by many medical device manufacturers on the long road to MDR compliance. In 2019 it will be important for them to carry on resolutely along that road, adapting both their own organisation and their cooperation with development partners, suppliers and distributors, and also notified bodies, to the new European regulations in order to achieve MDR compliance. This in spite of the fact that many questions thrown up by the MDR and IVDR have still not been resolved, in spite of the fact that essential instances such as the Eudamed database – on which manufacturers have no influence – are still not functioning properly, and in spite of the fact that a considerable number of notified bodies have so far not even made an application for accreditation under the MDR / IVDR. From that point of view, it is to be hoped that the year 2019 will at least bring clarity in some cases.

It's not as if the challenges referred to above only affect 'classical' device manufacturers. Increasingly, the products themselves are interconnected with databases of healthcare professionals, providers of maintenance services or patients' devices, or their application is supported by accompanying apps. Software may be qualifiable and classifiable as a medical device within the meaning of the MDR. The requirements relating to the (cyber-)security of digital products should not be underestimated.

Together with the recertification of their quality management scheme in accordance with DIN ISO 13485:2016, which must be finalised in 2019, manufacturers – of analogue and digital products – can only be encouraged and supported in their (continued) implementation of the requirements of the MDR / IVDR relating to quality management. It is important to focus carefully here on the configuration of the risk management system and the implementation of clinical assessments and clinical trials. The aim pursued with the MDR / IVDR, that of minimising the risks posed by medical devices to patients and users, also demands optimised supplier management from manufacturers, and closer cooperation with distributors too. It is a matter of being able to retrace the entire life cycle of the product all the way through into the supply chain, from the provider of development services on the one hand to the end user on the other, so that, when all is said and done, stringent contractual control of the interaction of the economic operators is necessary.

[January 2019]