On 6 January 2023, the European Commission (EC) published the legislative proposal to extend or amend the transitional deadlines for certain medical devices and in vitro diagnostic medical devices (IVD).
This is in follow up to the discussion within the EU Employment, Social Policy, Health and Consumer Affairs Council (the Health Council) on 9 December 2022 (as set out here) where the Health Council supported the EC’s proposal to delay the transitional deadlines to avoid causing harm to EU health systems and, most critically, patient care.
Legal basis relating to the key proposed legislative amendments
Consistent with the parent EU law instrument, the proposed legislative amendments are made on the basis of (a) completing the internal single market and (b) protecting public health by setting high standards of quality and safety of medical devices.
As detailed below, the proposed amendments:
- Confer specific powers on Member States to address disruption of product supplies under the so-called subsidiarity principle.*
- Adhere to the basic principle of proportionality to specifically address the supply disruption arising from shortage of Notified Bodies (NBs) so that the rules are not applied excessively.
The key proposed changes to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) are set out in the table below for ease of reference.
Consistent with the EC’s position declared at the meeting with the Health Council in December 2022, the legislative proposal removes the “sell-off” deadline provided in Article 120(4) MDR and Article 110(4) of In Vitro Diagnostic Regulation to avoid devices unnecessarily being removed from the EU market by 27 May 2025.
New deadlines and conditions under MDR | ||
Product Types and Characteristics New Deadline | Conditions | |
Conformity assessment involving a NB | ||
Class III, Class IIb implantable medical devices with the new deadline extended to 31 December 2027. The extension applies to certificates issued by NBs according to the Directives governing general medical devices or active medical devices from 25 May 2017, valid on 26 May 2021 and not withdrawn thereafter. Expired certificates will remain valid until the new deadline. | Specific conditions
General conditions
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Class IIb (other than implantable medical devices), Class IIa and Class I in sterile condition or having a measuring function with the new deadline extended to 31 December 2028 The extension applies to certificates issued by NBs according to the Directives governing general medical devices or active medical devices from 25 May 2017, valid on 26 May 2021 and not withdrawn thereafter Expired certificates remain valid until the new deadline | ||
Class III custom-made implantable medical devices with the new deadline extended to 26 May 2026. |
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Conformity assessment not involving a NB | ||
Medical devices, which did not involve NBs in the certification, with the new deadline extended to 31 December 2028. The extension applies to the declaration of conformity, under the Directive governing general medical devices, which was drawn up before 26 May 2021, but the conformity assessment under MDR requires involvement of a NB. | General conditions
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New deadline under IVDR | ||
An IVD lawfully placed on the market under the IVD Directive before 26 May 2022 may continue to be placed on the market. An IVD lawfully placed on the market from 26 May 2022 may continue to be placed on the market if a certificate is issued under IVD Directive and valid within the period indicated on the certificate except for certificates issued according to EC verification procedure under the IVD Directive which will become void by 27 May 2024. In respect of the above IVD types, the deadline for the IVD Directive to continue to apply until 27 May 2025 is removed. |
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Rationale for the urgent legislative actions and next steps
- The Commission recognises that the amendments should be adopted by the EU legislature due to exceptional circumstances arising from an imminent risk of shortages of medical devices and associated risk of a public health crisis.
- The amendments must be adopted by the European Parliament and the European Union Council under the co-decision procedure.
- The urgent legislative actions seek to ensure availability of medical devices whose certificates which have already expired or are due to expire before 26 May 2024 to provide legal certainty.
- Therefore, the legislative process will likely be truncated for the amendments to be adopted as soon as possible. For this reason, the normal eight-week period for Member States to consult internally under the applicable EU Treaties will be excepted.
* Subsidiarity principle means that EU action may only be taken if the aims of the envisaged measure cannot be achieved by Member States alone.
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