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In January 2024, the European Commission proposed to amend existing IVDR, MDR, and EUDAMED regulations. A similar proposal was seen in 2023 when the European Commission proposed amendments to MDR, which became a regulation in April 2023, where Medical Device Regulation 2017/745 was amended with Regulation 2023/607. You can read more about the MDR timelines by visiting this link - https://med-di-dia.com/news/eumdr-transitional-provisions-deep-dive

 

Coming back to the proposed amendments to EU IVDR, the European Commission’s proposal document discusses the potential shortage of lifesaving in-vitro Diagnostic devices. Much emphasis is being laid on legacy devices, as the proposal seeks the earliest timeline for legacy devices while a later one for class B and A sterile devices.

 

Let us review and understand the main points highlighted in the proposal:

• 1. The published document proposes the following - Further Extension of Transitional Provisions
  • 31 December 2027 for Class D and IVDs Covered by IVDD certificate
  • 31 December 2028 for Class C
  • 31 December 2029 for Class B and A sterile devices
• 2.  Gradual Implementation of EUDAMED
  • 2024 Post Market Surveillance and Market Surveillance Module activation
  • Q4/2025 Proposed Mandatory Use of EUDAMED
  • Q3/2026 implementation of Clinical Investigations Module
  • Q4/2027 Mandatory Use
  • Q2/2029 Transitional Period for adaptation
• 3.  Addition of Article 10A in MDR and IVDR, which requires manufacturers to issue a prior notice if the supply of certain medical devices and in vitro diagnostic medical devices is stopped and
• 4.  Mandatory implementation of a Quality Management System (QMS) by 26 May 2025

Find more details of the proposal by clicking here.

 

 

What does this mean for Manufacturers?

 

1. Manufacturers shouldn’t take their foot off the gas, considering this proposed extension means more time. Instead, utilise this time to act fast and comply with EU IVDR and EU MDR. When this proposal becomes a regulation, many giant manufacturers will knock on the doors of different notified bodies with their applications. This will affect the notified body’s capacity and cause a temporary disruption to the supply chain.
2. In the case where Manufacturers intend to stop the supply of certain devices, article 10A makes it mandatory to submit prior notice to the European Commission.
3. Regardless of the proposal's outcome, manufacturers must get active hands on implementing a QMS for the devices.
4. Manufacturers and all related suppliers should be ready for phased adaptation of EUDAMED. This includes timely registrations, appropriate labelling and supply chain management.

 

The regulatory experts at Med-Di-Dia are here to assist our clients in developing proactive strategies that view mandatory compliance as an opportunity, not a barrier. We offer personalized services to all companies and guide them in meeting local and global regulatory requirements.

 

Contact us today to receive a tailored strategy for your products and company!

Drop us an email – mdd@mddltd.com or submit a web query - https://mailchi.mp/1ca078737f9c/ivdr