New EU Medical Device Regulations: The Impact for Economic Operators
Two new EU Regulations entered into force on 26th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) replace the current three Directives, which have been in place since the early 1990s. There is a transition period for the implementation of the various elements of the new regulations, with MDR becoming fully operational in May 2020 the IVDR in May 2022.
Now is the time for those impacted by the changes to the medical devices regulatory landscape to prepare for implementation of the new regulations. In this, the first of a number of articles relating to EUDR, we look at some of the changes for Economic Operators.
In the current Directives, the legal responsibility for medical devices placed on the market lies firmly with the legal manufacturer of the device. The role of Authorised Representative for manufacturers based outside of Europe was established in the Directives but under EUDR the increased responsibilities of this role are more clearly defined. The new regulations specify obligations and responsibilities for all economic operators involved in the manufacture and supply of medical devices.
What Is An Economic Operator?
The term economic operator refers to manufacturers, authorised representative, distributors and importers. The EUDR provides greater legal clarity on the various roles and responsibilities, and distributors are included for the first time in the legislation. Although the manufacturer is ultimately responsible for ensuring that their medical device is compliant with the relevant legislation, the various economic operators each have a part of play in ensuring the safety and performance of the device throughout the supply chain. These obligations include proper storage and handling, traceability, reporting requirements and verification of aspects of compliance of the device with EUDR including CE mark, declaration of conformity and IFU and labelling requirements, among others. Economic operators are also required to cooperate with the manufacturer / authorised representative and the Competent Authority in relation to corrective actions. This represents a significant strengthening of the regulatory process over the existing Directives in providing greater legal clarity to economic operators.
Are you an economic operator? Are you aware of your responsibilities under EUDR? Do you have the resources and systems in place to fulfil your obligations under the new Regulations?
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