The Medical Device Regulation (MDR), or Regulation (EU) 2017/745, is a new European regulatory framework for medical devices that replaces the former Medical Device Directive (MDD). The MDD is a directive (a guideline) that gives the governments of individual countries some freedom to make their own legislation; the new MDR, on the other hand, is a regulation (binding legislation).

• Broader application range This means that more medical devices are covered by the new legislation
• Clinical evidence and documentation required for Class III medical devices, including Automated External Defibrillators (AEDs)
• Systematic clinical assessment of Class IIa and Class IIb medical devices
• Strict and clear documentation
• Better traceability of resources through unique identifiers (UDIs)
• Tightened supervision by notified bodies for certification to reduce risks from unsafe devices
• More control by notified bodies
• More supervision after the medical devices have been put on the market
• Designation of a person responsible for regulatory compliance
• Marketing authorization must be reapplied for all devices put on the market under the MDR

The new MDR regulations mainly affect economic operators (manufacturers, importers, distributors, dealers, resellers); they must ensure that their devices comply with the regulations.

As an end customer, you don’t need to do anything at this time!

However, it is possible that the new MDR regulations may affect the future availability of products. We recommend you check whether your current device is working properly and that you proceed carefully when choosing any new devices and/or suppliers in the future.

AED-Partner's dealers bear greater responsibility for:

• Confirming that devices comply with the regulations. This includes checking products for CE marking, declaration of conformity and UDI (Unique Device Identification) and notifying importers, authorized representatives in the European Community and manufacturers of any non-conformity
• Demonstrably guaranteeing that storage and transport conditions comply with the conditions specified by the manufacturer
• A quality management system in accordance with the requirements defined in ISO13485
• Checking whether the supplier complies with the regulations
• The supplier checks the purchasers, if he is an economic operator
• Implementing corrective actions as necessary
• Tracing all the products ever sold by the economic operator
• Maintaining a record of complaints, incidents, non-conforming devices, corrective actions and product recalls and returned devices as well as informing manufacturers, importers and authorized representatives in the European Community and providing information upon request
• Cooperate with unannounced inspections by competent authorities to verify compliance and impose sanctions for non-compliance

If you’re an end customer, you don’t need to do anything. However, it’s advisable to check whether your supplier complies with the MDR guidelines.

April 2020

Published amendment to the MDR extending the date of application for medical device manufacturers to 26 May 2021 due to the COVID-19 pandemic.

26 mei 2021

As of this date, new devices must meet the requirements of the MDR in order to be put on the European market.

26 mei 2024

Devices with a certificate from a European registered body under the Medical Device Directive (93/42/EEC) have an additional grace period; these may no longer be put on the market after 26 May 2024 if the manufacturer does not comply with the specific conditions set out in the MDR.

The brand-independent tool to comply with all regulations!

The MDR Support covers the following tasks:

• Traceability (receipt & dispatch)
• Use of the AED-Partner Quality Management System in accordance with the requirements defined in ISO13485
• Optional: chain traceability & control of distributors
• Portal for customer complaints/feedback
• Automatic Complaint Handling to manufacturer
• Data storage (legal time periods)
• Storage of goods
• Dropshipment
• Reports
• Recall & FCO/FSN database
• GDPR proof & without sharing customer data!