Medical Device Certification: Understanding the New Extension of the IVDR Transitional Periods
On July 9, 2024, the European Union introduced Regulation (EU) 2024/1860, amending the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. This amendment marks a significant update, extending the transitional periods for devices certified under the In Vitro Diagnostic Directive (IVDD). This extension is crucial for manufacturers navigating the evolving regulatory landscape of in vitro diagnostic (IVD) devices.
Key Highlights of Regulation (EU) 2024/1860
The new amendment provides additional time for devices previously certified under the In Vitro Diagnostic Directive (IVDD). The extension period varies based on whether a device has an IVDD certificate or is self-declared. Here’s a breakdown of the different scenarios:
1. Devices with an IVDD Certificate
For devices certified under Annex II List A, List B, or self-tests, and with a certificate issued from May 25, 2017, that was valid on May 26, 2022, the transitional period has been extended. These devices can continue to be placed on the market or put into service for a specified duration, provided the certificate remains valid and is not withdrawn.
2. Devices Without Notified Body Involvement
For devices that were self-declared under the IVDD and had a declaration of conformity before May 26, 2022, the extension also applies. However, several conditions must be met:
• Devices must still comply with IVDD requirements.
• No significant changes in design or intended purpose are allowed.
• The device must not pose an unacceptable risk to health or safety.
• Post-market surveillance, vigilance, and registration must comply to IVDR standards.
Why This Extension Matters
The extension allows manufacturers additional time to transition to the IVDR framework, which includes updated requirements for clinical performance, technical documentation, and post-market surveillance. This shift is essential for maintaining device safety and efficacy as per EU regulations.
Act Now to Ensure Compliance
The recent survey by the European Commission reveals that obtaining new Quality Management System (QMS) and product certifications can take between 6 to 24 months. Given the potential delays and backlogs with Notified Bodies, it is crucial for manufacturers to start the transition process as soon as possible.
How DEKRA Can Assist
DEKRA, as a Notified Body, is well-equipped to help you navigate the complexities of IVDR certification. Our team of experienced IVDR Technical File reviewers and auditors is currently free from waiting lists, enabling us to start assessing your application immediately.
By partnering with DEKRA, you can benefit from:
• Specialized Knowledge: Our experts are highly knowledgeable in IVDR requirements, ensuring thorough and accurate assessments.
• Efficient Reviews: With no current waiting list, we offer prompt and efficient review services.
Next Steps
To begin your journey towards IVDR certification, contact DEKRA today. We offer immediate access to a team of skilled IVD technical file reviewers and auditors, dedicated to medical device safety.
For more details on the new regulation and its implications, we recommend reviewing the full text of the amendment
(EU) 2024/1860
and the related
Q&A document
. Stay informed and act swiftly to avoid any delays in your certification process.
The time to achieve IVDR compliance is now. If you are interested in our services, please send an email
medical.global@dekra.com
to start the IVDR journey.