European Commission’s New Regulation Amending IVDR Transitional Provisions: What You Need to Know

The In Vitro Diagnostics Regulation (EU) 2017/746 (IVDR) is the new regulatory framework for In Vitro Diagnostics (IVD), replacing the IVD Directive 98/79/EC (IVDD). Until May 26, 2022, when the IVDR becomes fully applicable, both legal texts coexist. 

 Under the IVDR, the IVD sector is subject to new and stricter regulatory requirements, including a change in the way IVDs are classified. Under the new classification rules, most IVDs currently on the market will change from class A to a higher class (B, C, or D). Under the IVDD, around 90% of IVDs could be self-certified, whereas, under the new IVDR, 80% of IVDs will now require involvement and assessment from Notified Bodies (NBs).  

 Therefore, most IVD manufacturers will need to approach and apply to an NB to be able to commercialize their products in the EU market. This can become a challenging task for several reasons: 

 Since the IVDR was published in 2017, only six NBs have been certified under the IVDR—that’s only one-third of the NBs that were operating under the IVDD 

• With fewer NBs available and significantly more products needing the involvement of an NB to certify them, NBs are working on their full capacities and the majority are not able to accept requests and emit new certificates under the IVDR1 
• Consequently, a very low number of certificates have been issued so far by NBs under the IVDR, compared to the certificates which were issued under the IVDD.  

 This contributed to the EC’s proposal to delay the transitional provisions for some specific products. Without this delay, the market could have faced significant disruption in the supply of IVDs in the market for health institutions and the public.

The new proposed transition periods are: 

• Class A, self-certified: May 26, 2022  
• Class D: May 26, 2025 
• Class C: May 26, 2026  
• Class B: May 26, 2027 
• Class A, sterile: May 26, 2027  

Although manufacturers now have the new transition periods as time buffers, it is important to emphasize that May 26, 2022, is still the IVDR Date of Application and that manufacturers will need to comply with some IVDR requirements starting from that day.  Therefore, manufacturers should still aim to apply the IVDR requirements as soon as possible in order to be able to put the products on the market at due time and avoid certification bottleneck. An effective transition strategy and immediate implementation of the requirements will allow a company to be better prepared for the NB assessment and minimize expenses related to the IVDR transition. 

About Alira Health

Alira Health’s Regulatory Affairs team can support manufacturers with a smooth transition from IVDD to IVDR by:

• Assessing the IVD classification under the new IVDR rules
• Analyzing the already-generated IVDD data to see if it will comply with the IVDR requirements (gap analysis)
• Building a regulatory strategy and roadmap for IVDR regulatory compliance of the device
• Implementing the IVDR requirements and building the technical documentation of the device for submission to authorities
• Helping with other regulatory activities, including risk management, setting up a post
  market surveillance system, and implement a quality management system

References

• Notified bodies: capacity vs workload
• Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices

Abbreviations

• CE: Conformité Européenne
• EC: European Commission
• IVDR: In Vitro Diagnostics Regulation
• IVD: In Vitro Diagnostics
• IVDD: In Vitro Diagnostics Directive
• NB: Notified Bodies