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 and the IVDR in May 2022.
Please Note: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application. The date of MDR application has moved to May 26th, 2021. Articles that were written prior to the delay referenced the earlier date. However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration. Read more here.
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 form.
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: firstname.lastname@example.org or complete the webform below and we will get back to you.
Further MDR Reading from Acorn Regulatory
The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR
As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC).
The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Read more here.
Get The 1st Acorn Regulatory Medical Device Regulations Whitepaper
The new medical device regulations (MDR) will come into force in May 2020. In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations. For many companies, there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. Read the first whitepaper here
2nd Acorn Regulatory MDR Whitepaper
Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR and post-market surveillance. Read the second MDR whitepaper here.
The Medical Device Regulations – MDR – What You Need To Know
The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover from the MDD to MDR. During our interactions with these clients, many topics are being raised time and again. Read more here.