Six Responsibilities of Importers and Distributors under MDR 2017/745

MDR 2017/745, which comes into force on May 26th, 2020, greatly expands the responsibilities of importers and distributors in comparison to the current MDD 93/42/EEC. In this article, we look at the responsibilities of the importer and the distributor. 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.

6 Obligations of  the Importer & Distributor

The new MDR gives a definition of ‘Importer’ and ‘Distributor’ and outlines the obligations for each role. Importers and Distributor responsibilities under the new MDR now include the following:

1. ensuring the device is CE marked and that a Declaration of Conformity is available,
2. that the device is correctly labelled
3. where applicable a UDI has been assigned.
4. liaising with the manufacturer, authorised representative and importer/distributor (where applicable) regarding complaints, non-conforming devices, recalls and withdrawals
5. notification to the Competent authorities and Notified bodies (where applicable) of devices that present a serious risk
6. responsibilities regarding storage and transport conditions.

Eudamed Delay

MDR 2017/745 indicates that Importers must also now register their details in the new electronic database (EUDAMED) (the launch of which has been delayed until May 2022) The new MDR presents big changes to the regulatory obligations for importers and distributors of medical devices. It’s important that these important participants in the medical device supply chain understand these obligations and are preparing for the 26 May 2020 deadline when MDR comes into force.

We Can Help You With Your MDR Issues

Our team is currently working with a wide range of companies and devices, preparing them for May 2020.  If you would like us to help your company then get in touch.  Contact us by phone on 00353 52 61 76 706 or complete the form below and we will get back to you straight away. [ninja_form id=1]

Further Reading on MDR

A Guide to Drug Device Combination Products

We have produced a drug device guide that looks at the issue.  It also considers the issue in relation to the changes for drug device combination products in relation to the Medical Device Regulations.  You can download the guide here.

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.