In June 2021, the Member States and the Commission services released its initial Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The plan assessed and determined implementation priorities or areas, including “concrete priority actions,” to have an operational system established prior to the IVDR date of application, 26 May 2022.
An update to this joint plan
was released on 01 Apr 2022, just after its February update. The latest update includes the addition of two new “high priority” priority areas to address legacy devices and Eudamed and 2 new action items added within the previous 9 priority areas along with adjusted implementation timelines for several of the action items, as detailed below. As a reminder, the priority areas discussed within the plan are split into two sets. Set A includes “essential” priority areas vital for devices to have access to the market and set B includes “high priority” priority areas for legislation and guidance documents that are not required but would facilitate implementation by the actors, including manufacturers. Each of the priority areas includes detailed actions items to complete with proposed timelines for implementation.
Changes to Set A essential areas include:
- Area 1, Contingency planning and monitoring
- The timeline for action 1.3 Analyse the IVDR in context of hypothetical scenarios of an urgent response to a health crisis was again moved from Q1 2022 to Q2 2022.
- Area 2, Availability of notified bodies
- No changes were made to the priority action items.
- Within the discussion of action 2, the availability of notified bodies currently designated under the IVDD remains at 19 while only 6 notified bodies are designated under the IVDR.
Changes to Set B high priority areas include:
- Area 3, EU reference laboratories
- The timeline for action 3.2 Implementing acts on tasks and criteria and on fees was again moved from Q1 2022 to Q2 2022. The status for this item now states it is “in final stages of adoption.”
- The timeline for action 3.4 Issue call for application was again moved from Q1 2022 to Q2 2022.
- Area 4, Common specifications
- The timeline for action 4.3 Adoption procedure of the first implementing act on common specifications was again moved from Q1 2022 to Q2 2022.
- Area 5, Guidance for notified bodies
- A new priority action was added: 5.4 Develop guidance on appropriate surveillance as referred to in Article 110(3) of the IVDR (MDCG NBO WG, MDCG IVD WG, Commission, MDCG) with a timeline of Q3 2022. This was based on an identified urgent need for additional guidance regarding Article 110(3) second subparagraph for notified bodies, manufacturers as well as designating authorities to provide clarity on the meaning of “appropriate surveillance in respect of all applicable requirements relating to the devices it has certified”. It was stated that “in this context, a guidance document should specify the activities to be performed by notified bodies as part of the appropriate surveillance and also cover requirements concerning certain manufacturers’ obligations, especially in respect to their quality management system.”
- The timeline for action 5.3 Guidance on significant changes referred to in Article 110(3) was moved from Q1 2022 to Q2 2022.
- Area 6, Performance evaluation and expert panels
- A new priority action was added: 6.4 Develop and endorse template for application/notification of performance studies. (MDCG CIE WG, MDCG IVD WG, MDCG) with a timeline of Q2 2022. This addition was driven by new EU-level requirements regarding application for or notification of certain performance studies. It was recognized that while Eudamed is in development, a single EU-wide template for this, specifying a common set of elements to be provided and a common format to present them, would be of high added value to streamline the authorization or notification process. The recommendation is to base such a template on the analogous template for clinical investigations under the MDR. The template is expected to cover performance study application for certain high-risk performance studies (IVDR Art. 58(1 & 2)), PMPF study notification (IVDR Art. 70(1)), performance study notification involving companion diagnostics using left‐over samples only (IVDR Art. 58(2)), and other performance study application/notification - national application (Art. 57).
- The timeline for action 6.3 Template for summary of safety and performance was again moved from Q1 2022 to Q2 2022. The status for this item now states it is “In preparation for endorsement.”
- Area 7, Standards – no changes
- Area 8, Companion diagnostics – no changes
- Area 9, In-house devices
- The timeline for action 9.1 Guidance on in-house devices was again moved from Q1 2022 to Q2 2022. The status remains stated as “processing outcome of stakeholder consultation.”
- Area 10, Legacy devices
- This new “high priority” priority area was added to develop guidance to clarify the specific IVDR requirements that are applicable or not applicable to devices placed on the market prior to 26 May 2022 and for those that can lawfully be placed on the market according to the transitional provisions (‘legacy devices’). This was added recognizing that the wording of the updates to Article 110(3) transitional provisions for requiring post-market surveillance, market surveillance, vigilance, and registration of economic operators for all devices as of 26 May 2022 in accordance with the IVDR instead of those requirements in Directive 98/79/EC (IVDD) were rather general. The new guidance is expected to be similar to that provided for the MDR, MDCG 2021-25, but it was recognized that the existing guidance cannot be applied to IVD devices due to the differences between IVDs and medical devices (e.g., different classification systems), as well as the different transitional provisions.
- The new priority action added for this area is: 10.1 Develop and endorse a guidance document on the application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC (MDCG IVD WG, MDCG NBO WG, MDCG PMSV WG, MDCG MS WG, MDCG) with a timeline of Q2 2022.
- Area 11, Eudamed
- This new “high priority” priority area was added to provide guidance on harmonized administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional. This was added recognizing that Eudamed will not be fully functional by 26 May 2022, and that the transitional provisions of Article 113 (3)(f) mean that the system will not be mandatory or enforceable until six months after the date of publication of the notice in the official journal that EUDAMED is fully functional. The goal of the proposed guidance is to enable Member States and other relevant parties to meet their obligations under the IVDR effectively, while minimizing any potential additional burden on the parties concerned. It should address cases where the exchange of information would be difficult, or even not possible, to achieve in absence of guidance.
- The new priority action added for this area is: 11.1 Develop and endorse IVDR-specific guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (MDCG Eudamed WG, MDCG IVD WG, MDCG) with a timeline of Q2 2022.