EU MDR: What Will The Impact Be 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 EU MDR, 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 EU MDR 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 EU MDR 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 EU MDR 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.

Questions to Consider

  • Are you an economic operator?
  • Are you aware of your responsibilities under EU MDR?
  • Do you have the resources and systems in place to fulfil your obligations under the new Regulations?

This is just one of a number of articles in our ‘Understanding MDR’ series.  You can find another just below the webform.

If you would like to speak to us about issues relating to preparing for EU MDR or seek our advice then call us on 00353 52 61 76706, email us: info@acornregulatory.com or complete the webform below and we will get back to you.

The issue of the EU Authorised Representative and the MDR is one that is perplexing many people. Click here to read more on the issue from our expert team.

About the Author
Orla Keane
Medical Devices Manager
An engineer by background, she has 15 years experience in medical devices. Prior to joining Acorn Regulatory, she spent over 12 years at the HPRA in various roles within the medical devices team. She was responsible for a team within post market surveillance and vigilance across various general and active implantable medical device product families. Orla also served as co-Chair of the Compliance and Enforcement working group in Brussels for many years. She has previous industry experience at an orthopaedic implant manufacturer. Orla currently assists Acorn Regulatory clients in a variety of areas including regulatory strategy, EU authorised representative support and preparation for MDR, particularly on the topic of post market surveillance. You can read medical device and related articles written by Orla Keane by clicking the link below.
Other articles by Orla Keane