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: On this date, the amendment to the MDR was published. Due to the coronavirus pandemic, the effective date of the MDR for medical device manufacturers was postponed to May 26, 2021.

May 26, 2021: New devices must comply with the MDR before they can be placed on the European market.

Existing devices with an MDD certificate may be offered for sale until the expiration date of the certificate (with the latest date being May 25, 2024).

March 15, 2023: Regulation 2023/607 is in force.* Devices that were placed on the market before May 26, 2021, based on an MDD certificate and have not undergone any changes, may be offered or put into use without complying with the MDR.

*This regulation eliminates the previously planned 'sell-off period' (until May 26, 2025) for these devices.

Regulation 2023/607 was introduced in light of the capacity shortage at notified bodies responsible for assessing medical devices. The regulation provides them with more time.

For manufacturers, May 26, 2024, remains an important date. This is the deadline for submitting devices to a notified body for re-evaluation.

A device can only be provided with an 'extended MDD certificate' if, at the expiry of the MDD certificate, the manufacturer has submitted all necessary information for the (MDR) assessment to the notified body, the notified body has accepted this information, and an agreement has been reached for the assessment of the device.

The notified body is obligated to assess the devices within a specified timeframe. For higher-risk class products, such as AEDs, they must be re-evaluated by December 31, 2027. For lower-risk class products, December 31, 2028, is the latest re-evaluation date.

May 26, 2024: Devices with an MDD certificate that do not meet the new MDR requirements or do not have an extended MDD certificate may no longer be offered.

December 31, 2027: Higher-risk class devices without a valid MDR certificate may no longer be sold on the European market.

December 31, 2028: Lower-risk class devices without a valid MDR certificate may no longer be sold on the European market.

Do you have specific questions about the MDR legislation? Our experts are happy to assist you. You can email your question to quality@aedpartner.nl.

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!