New information obligation for manufacturers (and other economic operators) of medical devices

It has been in the news for some time that major shortages of medical devices are looming. For example, Zorgvisie[1] headlined "Alarm over medical devices: shortages from 26 May" on 12 March 2024. Within Europe, rules in this regard have been under consideration for some time. On 23 January 2024, the European Commission published a proposal for a Regulation[2] ("Proposal") to update the provisions of the IVDR[3] and MDR[4] with the aim of reducing shortages of critical medical devices (for in vitro diagnostics). Part of the Proposal is an information obligation for manufacturers and other economic operators. The Proposal has now also been adopted. This blog explains this information obligation in more detail.

Rationale, relevant concepts and frameworks

The Proposal explicitly mentions that one of the reasons for the information obligation is the slow transition to Regulations (EU) 2017/746 (‘IVDR') and (EU) 2017/745 ('MDR'). For example, there has been a delay in the development of the EUDAMED system[5] and insufficient notified bodies to carry out the conformity assessments and certify medical devices mentioned in the MDR and IVDR.

Among other things, the Proposal aims to require manufacturers to give advance notice if they expect an interruption in the supply of certain "critical" medical devices and in vitro diagnostic medical devices.

What does the duty to inform entail? This article is limited to the MDR. Article 10 MDR sets out the general obligations of manufacturers. The Proposal seeks to add an article to it; Article 10bis. Article 10bis "Obligations in case of interruption of supply of certain devices" consists of three paragraphs and reads as follows (emphasis added):

" 1. Where a manufacturer anticipates an interruption in the supply of a device, other than a custom-made device, and where it is reasonably foreseeable that such interruption may result in serious harm or risk of serious harm to patients or public health in one or more Member States, the manufacturer shall inform the competent authority in one or more Member States, the manufacturer shall inform the competent authority of the Member State where it or its authorized representative, 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." (underlining added)

It states that a manufacturer must inform the competent authority (which in the Netherlands is the Health and Youth Care Inspectorate ("IGJ")), economic operators, healthcare institutions and healthcare professionals if they reasonably foresee an interruption in the supply of the medical devices. This must be done (by the manufacturer) at least six months before the expected interruption, unless there are exceptional circumstances and “without undue delay” by the other economic operators after they have received the information from the manufacturer. What the exceptional circumstances are is not explained. The wording "shall inform" in Article 10a MDR is also used in, for example, food regulations (Article 19 of Regulation (EC) 178/2002) for a food operator's duty to notify if a food does not meet food safety requirements or is harmful.

Scope of information obligations: manufacturers and other economic operators

It is also notable that the information requirement is not limited to "critical medical devices". Page 12 of the Proposal states (emphasis added): "Article 1 introduces a new Article 10a laying down an obligation on manufacturers to give prior notice about interruption of supply of certain critical medical devices." There is however no further indication in Article 10a MDR that the information obligation is limited to “certain critical medical devices”. It is not clear why Article 10bis MDR extends to all devices other than a custom-made device.[6] In practice, this could potentially lead to discussions.

Moreover, an information obligation is not only implemented for the manufacturer, but also for the other economic operators (e.g. the authorised representative, distributor or importer) who have received the information about the expected interruption from the manufacturer. These in turn must "immediately" inform other economic operators, health institutions and healthcare professionals of the expected interruption. By doing so, the Proposal aims to ensure that the entire (supply) chain is reached. The Proposal gives the following explanation: “Besides notification to the relevant competent authorities, manufacturers should also inform health institutions or healthcare professionals and economic operators to whom the directly supply the device. The relevant economic operators should provide the information in the downstream supply chain until it reaches the health institutions or healthcare professionals. This mechanism will enable the authority and health institutions to consider mitigating measures to ensure patient health and safety.”

More rules at EU level: raw materials, medicines and food

The Proposal is not the first European measure that has been or will be taken to limit or prevent certain shortages. Previously, the so-called 'European Critical Raw Materials Act' was proposed to limit and prevent shortages of indispensable raw materials for (for example) phones, laptops and electric cars. Critical raw materials have been defined in this Act. Can we expect new rules for "critical" foods, "critical" medicines, et cetera? New rules are already on the way for the latter category. As for the former category, the European Parliament has already taken measures in 2022 to maintain food supply in the European Union and Ukraine. The European Parliament also wants to increase agricultural production in the European Union to ensure global food security. As part of the measures, an emergency plan to ensure food supply and food security in times of crisis was also adopted in 2021.[7] The mechanism is triggered when exceptional, unpredictable and large-scale situations occur that could threaten food supply within the European Union.

Consequences?

Back to the new disclosure requirement under the MDR. What the consequences will be of failure to "notify" in a timely manner ex article 10a MDR is not further explained in the Proposal. Because article 10a is included among the manufacturer's obligations, failure to notify would trigger a violation of the MDR. This could have implications not only in civil relationships (contracts), but also for any action that the competent authority (IGJ) may take if the manufacturer (or other market participants) were to breach article 10a MDR.

Questions?

Should you have any questions about the Proposal and its implications for your business, please contact Mirjam Louws directly (m.louws@ploum.nl or +316 28636204) or any of our team members within Ploum's Customs, Trade & Logistics team.