Joint implementation and preparedness plan for IVD Regulation. MDCG releases updated implementation plan for In-Vitro Diagnostic Regulations
On 7th February 2022, Directorate-General for Health and Food Safety - MDCG, updated the Joint Implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the IVDR.
Medical Device Coordination Group (MDCG), composed of experts appointed by Member States, endorsed a joint implementation plan on the implementation of the MDR and now, launched the same for In-Vitro Diagnostic Regulations.
The short transitional period originally envisaged for the application of the MDR (3years) is in the interest of patient safety and in response to scandals with defective medical devices in the past. It aims to ensure that the strengthened requirements of the new framework apply as soon as possible. The IVDR pursues the same objectives but has a longer transitional period of 5 years. This is to allow more time to introduce many fundamental changes in the way the sector operates:
- a new device classification system
- much greater involvement of notified bodies in conformity assessment of devices
- new regulatory structures such as the EU reference laboratories and expert panels
the document mentions in bold - The implementation of the IVDR has proven to be a very challenging task for the whole sector and all concerned: stakeholders, the European Commission and Member States. This clearly highlights the fact that IVD manufacturing companies need to focus more on regulatory affairs. It is companies and the manufacturers who will need to comply to conformity. If any of the regulatory guidelines are comprised, manufacturers and their partners [includes EU AR] will face serious consequences.
Owing to all the implications and challenges of implementation, the responsible authorities have undertaken various measures to ensure a smooth transition for all stakeholders. This document (end of the update) highlights the actions that are being taken and lists the sets of priority.
The Priorities are split into two sets
- Set A - includes actions that are vital for devices to have access to the market (those related to a framework for contingency planning and availability of notified bodies).
- Set B - includes legislation and guidance documents that, while not obligatory, would greatly facilitate the work of the actors as well as designation of EU reference laboratories for high-risk IVDs.
Apart from setting the priorities, the Plan will serve as a living document to monitor their implementation. The status and timelines of the items will be updated to reflect the progress of the work.
Based on different sections and explanations, the list of priority from Set A includes:
- 1.1 Engage in an MDCG-level forum to communicate on critical issues related to IVDR implementation, on potential risks of shortages and measures taken to ensure availability of safe and critical IVDs. (Commission, MDCG)
- 1.2 Perform a market monitoring exercise to obtain as much data as possible on the preparedness of different stakeholders and aiming at detecting possible barriers that could lead to shortage of devices on the market (Commission, CAMD)
- 1.3 Analyse the IVDR in the context of hypothetical scenarios of an urgent response to a health crisis, scenarios to consider and methodology to be defined (Commission, MDCG IVD WG)
- 2.1 Make available national experts for joint assessment of notified bodies (Member States)
- 2.2 Consider how notified bodies can perform conformity assessment activities in COVID-19 circumstances (Commission, MDCG)
- 2.3 Member State discussion on increasing notified body capacity (MDCG, MDCG NBO WG, MDCG IVD WG, Commission)
- Based on different sections and explanations, the list of priority from Set B includes:
- 3.1 Discussion with Member States on practical aspects related to EU reference laboratories (Commission, MDCG/MDCG IVD WG)
- 3.2. Adopt implementing acts on tasks and criteria and on fees to be levied by the EU reference laboratories (Commission, Committee on Medical Devices)
- 3.3 Carry out survey on needed capacity of EU reference laboratories (Commission)
- 3.4 Issue call for application to Member States and the Joint Research Centre (Commission)
- 3.5 Assess the applications and designate the EU reference laboratories (Commission)
- 3.6 Investigate a Union contribution for tasks that are not covered by fees (Commission)
- 4.1 Propose the sets of CS will form part of the first adoption round (Commission)
- 4.2 Agree on the text to be adopted as part of the first round (MDCG IVD WG, MDCG, Commission)
- 4.3. Adopt the first implementing act containing common specifications (Commission, Committee on Medical Devices)
- 5.1 Complete and endorse guidance on notified body designation codes. (MDCG NBO WG, MDCG IVD WG, Commission, MDCG)
- 5.2 Complete and endorse guidance on batch testing for notified bodies (MDCG NBO WG, MDCG IVD WG, Commission, MDCG)
- 5.3 Develop guidance on significant changes as referred to in Article 110(3) of IVDR (MDCG NBO WG, MDCG IVD WG, Commission, MDCG)
- 6.1 Complete and endorse guidance on clinical evidence for IVDs. (MDCG IVD WG, MDCG CIE WG, MDCG)
- 6.2 Develop and endorse a clarification on what constitutes a “type of device” and on the process to be followed by notified bodies in context of views of the expert panel. (MDCG NBO WG, MDCG IVD WG, MDCG)
- 6.3 Develop and endorse template for summary of safety and performance (MDCG IVD WG, MDCG CIE WG, MDCG)
- 7.1 Adopt the implementing act on the MDR/IVDR standardisation request (Commission, Committee on Standards) and accept it (CEN/Cenelec)
- 7.2 Adopt the implementing acts on the publication in the OJEU of references of harmonised European standards in support of the IVDR requirements (Commission)
- 8.1 Regarding the consultation of medicinal product authorities, accompany the work of the EMA and stakeholders, notably on procedural elements (MDCG IVD WG, medicinal product authorities, EMA)
- 9.1 Develop guidance explaining the provisions on in-house devices (MDCG IVD WG, MDCG MS WG)
While major tasks is being done by regulators and other associated parties, manufacturers should start planning and preparing for the new updates.
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The Publication was again updated in March 2022 and Published on 01/04/2022