EU New Updated Amendment!

A new amendment to EU 2017/745 (EU MDR) has been published in the Official Journal of the European Union. The release of Regulation 2023/607 on March 15, 2023 amended the validity deadlines for certificates issued in accordance with the EU MDD (90/385/EEC or 93/42/EEC). Certificates issued under MDD will remain valid until:

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• December 31, 2027 for class III devices and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws wedges, plates, wires, pins, clips and connectors

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• December 31, 2028 for class IIb other than those covered by the previous point

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• December 31, 2028 for class I devices placed on the market in sterile condition or having a measuring function.

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• December 31, 2028 devices for which the conformity assessment procedure did not require the involvement of a notified body and where the declaration of conformity was drawn up prior to May 26, 2021.

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Devices which fall into the categories above may be placed on the market or put into service until those dates as long as the following conditions are met:

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• The devices must continue to comply with the applicable directives

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• There must be no significant changes to the design or intended purpose

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• The devices must not present an unacceptable risks to health or safety.

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• The manufacturer must have a quality system which meets the requirements in EU MDR must be put in place by May 26, 2024

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• The manufacturer or authorized representative must submit a formal application with a notified body for a conformity assessment of the device by May 26, 2024 and a written agreement with a notified body for the conformity assessment of the device must be in place by September 26, 2024.

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Additionally, class III custom-made implantable devices may be placed on the market until May 26, 2026 without a certificate issued by a notified body provided that the manufacturer or authorized representative has submitted a formal application with a notified body for a conformity assessment of the device by May 26, 2024 and a written agreement with a notified body for the conformity assessment of the device is in place by September 26, 2024.

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Manufacturers and authorized representatives should also keep in mind that the MDR requirements for post-market surveillance, vigilance, and registration of economic operators apply even to the devices marketed under the MDD conformity assessment during this transition time.

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Although this extension provides additional time for manufacturers and notified bodies to update legacy devices to meet EU MDR requirements, it's important to note that notified bodies may be overwhelmed as the deadline approaches, potentially leading to delays in processing certifications. Therefore, it's highly recommended that manufacturers prioritize obtaining EU MDR certification as quickly as possible to avoid potential delays or non-compliance. It's unlikely that the EU Parliament will grant any further extensions.