Extended Transitional Period for Class I Devices

by | Dec 20, 2019 | EU, EU MDR, FDA, Medical Devices, Quality Systems

The up-classification of devices under the new EU MDR has definitely put some manufacturers in a very difficult situation. This is true especially for manufacturers of class I devices that have now been up-classified under the new EU MDR.

Under the EU MDD, Class I devices were not required to involve a notified body to get the authorization to market the product in the EU. Some class I devices have been up-classified under the EU MDR and an extended transitional period has become more important than ever since the EU MDR application deadline is fast approaching.

A new corrigendum is going through the process of approval to grant an extended transitional period for up-classified class I devices. The corrigendum proposes to change article 120 of the MDR. The proposed change will allow for devices to be placed on the market until May 26, 2024, if they were classified as Class I under the EU MDD and have renewed the declaration of conformity before May 26, 2020. The proposed corrigendum will override the current provision that allows for certificates to be valid until its expiry on May 26, 2024, whichever is earlier. This provision is not applicable to class I devices since they did not have a certificate issued by a notified body.1

The proposed corrigendum does have a caveat. MDR requirements such as the post-market surveillance activities, market surveillance by national authorities, vigilance reporting, and registration of devices and economic operators still apply. Secondly, no changes can be made to the intended use and the design of the device in the extended transition period.1

The corrigendum is pending approval by the European Parliament to go into full implementation. We will know for sure after the Parliamentary sessions between December 16th and 19th. EMMA International will keep you updated on any further developments on this topic.1

Need help with your EU MDR transition? Call us at 248-987-4497 or email us at info@emmainternational.com.

1BSI (Dec 2019) Transitional period proposed for MDD class I devices with higher classification under MDR retrieved on 12/19/2019 from https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/transitional-period-proposed-for-mdd-class-i-devices-with-higher-classification-under mdr/?utm_source=pardot&utm_medium=email&utm_campaign=SM-SUB-LG-HLTH-CN_blog-2019

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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