Regulation (EU) 2017/745 on medical devices is a European law that applies in all EU countries. This law ensures that medical devices placed on the European market are safe for patients.

This law is also popularly known as the MDR. This abbreviation comes from the English name of this law: Medical Device Regulation. Only products that meet these requirements receive an MDR certificate.

At the moment, some AEDs still have an old certificate (MDD). These AEDs may still be sold until December 31, 2027. After December 31, 2027, only AEDs with a new certificate (MDR) may be sold.

Do you have an AED with an MDD certificate? Then you may continue to use it after December 31, 2027.

The MDR replaces the MDD: the Medical Device Directive. The MDD was a guideline, meaning that countries still needed national legislation in addition to the MDD. With the MDR, it works differently. The MDR is a regulation: a law that is directly valid and binding in all EU countries from its effective date. This way, the same rules and standards apply everywhere.

Only products that comply with the MDR will receive an MDR certificate. Currently, some AEDs still have an old certificate (MDD). These AEDs may still be sold until December 31, 2027. After December 31, 2027, only AEDs with a new certificate (MDR) may be sold.

Do you have an AED with an MDD certificate? Then you may continue to use it after December 31, 2027.

1. Wider application range: More medical devices fall under the new legislation.

2. Clinical evidence and documentation: For medical devices of class III, such as automated external defibrillators (AEDs), stricter requirements apply.

3. Systematic clinical assessment: Manufacturers of Class IIa and IIb medical devices must evaluate their clinical data and demonstrate that their device is safe and effective.

4. Documentation: stricter and clearer requirements.

5. Traceability: assistive devices are more traceable via unique identification codes (UDIs).

6. Supervision by notified bodies: the rules for supervision during and after certification have been tightened to reduce the risks of unsafe devices. Testing is carried out more frequently and in greater numbers.

7. Regulatory Affairs Responsible Person (PRRC): each manufacturer and authorized representative must appoint a responsible person to oversee regulatory compliance.

8. Renewal Approval Required: for all devices, a new approval must be sought to market them under the MDR.

9. Forwarding of notifications: supply chain participants must pass on notifications regarding supply interruptions received from a European manufacturer to their customers.

April 5, 2017
Regulation (EU) 2017/745 was published.

April 24, 2020
Due to the corona pandemic, the entry into force date was postponed to May 26, 2021.

March 15, 2023
Regulation 2023/607 entered into force due to capacity shortfalls at notified bodies. Medical devices already on the market before May 26, 2021, with an MDD certificate, may still be sold without MDR certification under certain conditions. This gave notified bodies more time to reassess medical devices. Manufacturers who wished to take advantage of this grace period had to submit and contract their device for reassessment with a notified body before May 26, 2024.

The notified body undertakes to assess the devices within a specified period. For products in higher risk classes, such as AEDs, December 31, 2027, is the final reassessment date. For products in lower risk classes, that date is December 31, 2028.

May 26, 2024
Products that do not have MDR certification or an extended MDD certificate may no longer be offered on the market.

January 10, 2025
Regulation 2024/1860 enters into force
Manufacturers are required to report supply disruptions of medical devices. If you receive such a notification from the manufacturer, please forward it to the supply chain participants downstream from you.

December 31, 2027
Devices in higher risk classes without a valid MDR certificate may no longer be sold.

December 31, 2028
Medical devices in lower risk classes without a valid MDR certificate may no longer be sold.

The new MDR regulations primarily affect market participants: manufacturers, authorized representatives, importers, and distributors of medical devices. The law defines distributors as anyone who sells or makes medical devices available on the market. Resellers of AED-Partner also fall under this category.

All market participants must ensure that the devices they offer comply with the MDR regulations. Your obligations as a market participant depend on your role in the chain. A detailed explanation of the obligations can be found in the Official Journal of the European Union.

AED-Partner complies with the MDR. If you, as a reseller of medical devices, purchase from us for resale, then the same obligations apply to you as to AED-Partner.

A selection of those obligations:

• Confirming that medical devices comply with MDR regulations: is there a CE mark on the product, is there a manufacturer's declaration of conformity, and does the device have a UDI (Unique Device Identification)?
• Keeping records for complaints and incidents, among other things.
• The tools you sell track: register to whom you sell them so you can track them. Legal retention periods apply to documentation.
• Store and transport medical devices according to the conditions specified by the manufacturer.
• Report non-conformities to your supplier. Your supplier will then share this information with the market participant(s) earlier in the chain.
• Participate in manufacturer's Field Safety Corrective Actions (FSCA), regulatory authority and notified body inspections.

A comprehensive explanation of all obligations can be found in the Official Journal of the European Union.

If you buy or own an AED for personal use, nothing changes due to the MDR. However, you may notice that some brands or models of AEDs are no longer available for purchase. This is because not all products comply with the new regulations.

On December 31, 2027, AEDs without MDR certification will no longer be allowed to be sold. Do you, as an end customer, have an AED with an MDD certificate? Then you may continue to use it after December 31, 2027.

Are you buying an AED and then reselling it to someone else? Then you are selling a medical device. All MDR obligations that apply to AED-Partner as a seller also apply to you as a reseller.

Do you have a question about your AED and the MDR? Our Customer Service staff know the devices well and provide you with free advice.