The European Union (EU) Medical Devices Regulation (MRM), officially adopted in April 2017, may lead to significant changes in the regulatory obligations of manufacturers, importers and distributors participating in the medical device distribution chain. Accordingly, the PRRC should be hired through an employment contract or consulting contract that must expressly confirm their obligations. It should also ensure that aircraft compliance is verified in accordance with the QMS, the development and updating of technical documentation, and the recording of control measures and serious incidents on site. In the event that these obligations are not met satisfactorily despite performance controls, the manufacturer should have the right to terminate the contract and ensure that a new PRRC can be appointed as soon as possible, as this will of course be a critical function for organizations. The EU Medical Devices Regulation, which will come into force on 26 May 2020, will not only lead to significant changes in the regulation of medical devices, but also to a greater consideration of agreements between a legal manufacturer (.dem i.e. a company that puts a product on the market under its own name or brand) and third parties. Finally, it should be stressed that distribution and supply agreements provide only for formal compliance with the rules. In practice, economic operators must examine how relevant information can be shared and managed to comply with legislation, so that actions taken by a particular economic operator do not compromise the interests or respect of other partners upstream or downstream. New under the MDR in the EU A system of checks and balances is an important priority in the new distribution chain for medical device manufacturers. Each economic operator must verify that a previous economic operator has met the EU`s MDR requirements. Therefore, importers and distributors must independently ensure that the manufacturer, importer and device itself, prior to the introduction of a medical device, comply with EU-MDR rules. These new amendments should be carefully considered in the review of the ongoing procurement and distribution agreements, in accordance with the EU MDR, and all parties to the agreement should make these new commitments with full understanding of all responsibilities.
Given the importance of the EU`s human rights requirements, obligations should be met without delay in order to avoid individual liability issues. The blog post below provides an overview of the changes to be presented by the EU MDR for medical device manufacturers, importers and distributors – collectively defined as economic operators – and the impact these new obligations may have on ongoing supply and distribution agreements. It is essential that each party ensures the implementation and compliance of distribution agreements when signing or updating distribution agreements. EU regulators can – and probably will – impose sanctions on non-compliant economic operators for serious offences found.