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.

More Resources

Establishing a Culture of Compliance

Establishing a Culture of Compliance

While having robust compliance policies and procedures in place is essential for meeting regulatory requirements, it's equally important to establish a culture of compliance within your organization.  A culture of compliance means that every employee understands the importance of compliance and is committed to upholding it in all their work. Here are some tips for establishing a culture of compliance...
Change Management And Control

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
Aseptic Technique and Gowning

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...

Ready to learn more about working with us?

Pin It on Pinterest

Share This