Can I Purchase a Device Certified Under MDD and Not MDR?

Can I Purchase a Device Certified Under MDD and Not MDR?

Published on 12 September, 2024 by Evangelos Mantadakis

If you're wondering whether it's still possible to purchase a medical device that holds certification under the old Medical Devices Directive 93/42/EEC (MDD) instead of the new Medical Devices Regulation 2017/745 (MDR), the answer isn't straightforward. The MDR, which replaced the MDD, brings stricter regulations to ensure that all medical devices on the market are safe and effective. However, there is a transitional period during which some MDD-certified devices can still be sold under certain conditions.

What Does the MDR Mean for MDD-Certified Devices?

The MDR was introduced to enhance the safety and quality of medical devices in the EU market. It replaced the MDD and brought in stricter requirements for manufacturers. However, many devices that were certified under the MDD continue to be available on the market due to the transition period defined in Article 120 of the MDR.

According to Article 120, manufacturers with MDD-certified devices can still place them on the market, provided they meet specific conditions, which include maintaining compliance with MDD standards and ensuring the device does not undergo significant changes in design or intended use.

Transition Period Extension: Regulation (EU) 2023/607

The most recent amendment (related to the transition period extension), Regulation (EU) 2023/607, extends the transitional period for MDD-certified devices, offering manufacturers more time to comply with MDR. This extension is crucial, especially due to the delays caused by the COVID-19 pandemic and the limited capacity of notified bodies.

The new transitional periods depending on the device�s risk class, the classification rules laid down in Annex VIII to the MDR apply

This extension gives manufacturers additional time to meet the MDR's requirements without immediately withdrawing MDD-certified products from the market.

Key Compliance Questions for MDD-Certified Devices

If you�re looking to purchase a device certified under MDD, the manufacturer must be able to answer the following:

  1. Does the device comply with the MDD? Even during the transition period, devices must continue to meet MDD standards.

  2. Has the design or intended purpose of the device changed? Significant changes would mean the device no longer qualifies for the transitional period and must be recertified under MDR.

  3. Does the device present an unacceptable risk to health or safety? The device should not present any unacceptable risk to health or safety.

  4. Has the manufacturer put in place a Quality Management System (QMS) pursuant to Art. 10(9) MDR no later than 26 May 2024? By 26 May 2024, manufacturers must have a QMS in place that complies with Article 10(9) of MDR.

  5. Has an agreement between the manufacturer and a Notified body been concluded no later than 26 Sept 2024? The application process must be initiated by 26 May 2024, and an agreement with the notified body must be in place by 26 September 2024.

Next Steps for Manufacturers and Buyers

Manufacturers can provide a written confirmation about the status of their MDD-certified devices, and notified bodies can issue corrections or add information to existing certificates. Buyers should seek this confirmation from manufacturers to ensure the device complies with regulations during the transition period.

There is also a manufacturer�s declaration template available, which can help manufacturers confirm the status of their MDD-certified products during this period. This template was jointly developed by AESGP, COCIR, EuromContact, EUROM VI Medical Technology, and MedTech Europe. The declaration template helps manufacturers confirm that their devices continue to meet the requirements set out by the MDD/AIMDD while ensuring they are on track to comply with the stricter requirements of the MDR by the relevant deadlines. You can find and download the template directly from MedTech Europe's resource library here.

Conclusion

If you�re considering purchasing a device that is still certified under MDD, it's essential to confirm its compliance with the transitional requirements under MDR. The extended deadlines allow manufacturers time to transition, but you should ensure the device remains safe and compliant during this period. Always ask for written confirmation from the manufacturer regarding the status of the device.

For more detailed guidance, you can review the latest MDR amendments or consult with your supplier. You can also check resources like the MDCG 2020-3 guidance and other official documents related to the MDR and MDD transition.

For more information, please visit our resource library at QC Analytics.