The EU Commission issued a proposal to:
The Proposal will be put forward to the European Parliament and Council for adoption.
The announcement is available: HERE
The Commission is concerned regarding the lack of Notified Body applications, especially for high-risk IVDs. The Commission notes that “it is estimated that around 70% of clinical decisions are made using in vitro diagnostic medical devices.”
Class A non-sterile devices already had to comply with the IVDR on its original date of application (26 May 2022).
This is not a postponement for new products. It is a postponement to ‘legacy’ devices. IVDs new to the market must comply with the IVDR before being placed on the market.
*For more information on this topic, please read: Legacy Devices – Definition, Conditions, Deadlines
A new section to Article 10 (General obligations of manufacturers) is being proposed. This will affect both the MDR and IVDR.
This new section will require that manufacturers give at least six months’ advance notice, if they expect an interruption to the supply of critical products. Notice must be given to the relevant competent authorities, health institutions or healthcare professionals, and economic operators (e.g., importers, distributors, procedure pack producers) to whom they directly supply the device.
This requirement will apply to both MDR/IVDR CE marked and legacy (MDD/AIMDD/IVDD) CE marked devices.
“Article 10(a) Obligations in case of interruption of supply of certain devices
(1) Where a manufacturer anticipates an interruption of the supply of a device, other than a custom-made device, and where it is reasonably foreseeable that this interruption may result in serious harm or a risk of serious harm to patients or public health in one or more Member States, the manufacturer shall inform the competent authority of the Member State where it or its authorised representative is established, as well as the economic operators, health institutions and healthcare professionals to whom the manufacturer directly supplies the device, of the anticipated interruption.
The information referred to in the first subparagraph shall, other than in exceptional circumstances, be provided at least six months before the anticipated interruption. The information provided to the competent authority shall specify the reasons for the interruption.
(2) The competent authority that has received the information referred to in paragraph 1 shall inform without undue delay the competent authorities of the other Member States and the Commission of the anticipated interruption.
(3) The economic operators who have received the information from the manufacturer in accordance with paragraph 1, shall inform without undue delay any other economic operators, health institutions and healthcare professionals to whom they directly supply the device of the anticipated interruption.’”
Current legislation stipulates EUDAMED will not be mandatory until all six modules are fully functional. At this time, only three of the six modules have been released (and are available for voluntary use).
EUDAMED was originally scheduled to ‘go-live’ on the MDR’s original date of application (26 May 2020). However, it has been beset with delays. It is now not expected to be fully functional until 2027, at the earliest.
The Commission is proposing that EUDAMED modules become mandatory in a gradual roll-out, instead of requiring the entire system to be fully functional.
Per the press release, some modules may become mandatory by late 2025. Presumably, this will include the modules related to Economic Operator and device registration.
Both the MDR and IVDR would be amended for this change.
The EUDAMED Actor and UDI/Device registration modules will be applicable for both MDR/IVDR and legacy (MDD/AIMDD/IVDD) devices.
NOTE: In principle, all custom-made devices, except Class III implantable, are excluded from EUDAMED registration requirements. Instead, custom-made devices require registration with each national Competent Authority, on a case-by-case basis. However, in some situations, custom-made devices will still need to be registered in EUDAMED, e.g., in order to report a serious incident or to submit a trend report.
The Commission will be evaluating how the new legislation (MDR, IVDR) is impacting the availability of certain devices on the European market, such as innovative devices and pediatric devices. Further, it will assess the costs and administrative burdens of complying with the legislation; particularly, its impact on small-to-medium-sized manufacturers.
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