The EU is preparing and implementing several new legislations that may impact medical device manufacturers in the upcoming years. We will briefly assess some of the most relevant regulations and their status.
Status: finalized
The Regulation on Machinery Products
On 29 June 2023, the Official Journal of the European Union (OJEU) listed the new Machinery Regulation 2023/1230 text that will repeal the existing Directive in 2o27. The new Regulation aims to increase trust in new technologies, lower administrative burdens, and strengthen market surveillance.
- Impact (direct for certain types of devices): Manufacturers should look into Annex I of the Machinery Regulation for medical devices that are also machinery (MDR Article 1(12) & IVDR Article 1(6)). Namely, to verify and comply with machinery requirements that are more specific than those listed in the MDR Annex I, Chapter II.
This regulation shall apply from 20 January 2027, with some exceptions applicable already from 19 July 2023 (market surveillance actions).
EMA Regulation
Manufacturers should also be aware of the Regulation granting greater competences to the European Medicines Agency (EMA), which imposes new obligations on different economic operators, especially in a public health emergency (Article 26). To prepare the EMA in crisis preparedness and management for medicinal products and medical devices, the regulation addresses the following points:
- Monitoring of events and preparedness for public health emergencies and major events;
- Establishment of a European shortages monitoring platform and the Executive Steering Group on Shortages of Medical Devices;
- Monitoring shortages of medical devices on the public health emergency critical devices list;
- …
- Impact: Direct for devices included on the List of critical medical devices.
The regulation is applicable from 2 February 2023.
The General Product Safety Regulation (GPSR)
On February 2023, the Official Journal of the EU published Regulation 2023/988 on general product safety, which amends the General Product Safety Directive 2001/95/EC. Among others, the scope of this regulation applies to products that are placed or made available on the market with no specific provisions with the same objective under EU law, which regulate the safety of the products concerned.
There are new obligations for manufacturers, importers, distributors, online marketplace providers, and authorized representatives.
- Impact (only for certain types of products, for ex.): Companies placing systems or procedure packs on the EU market under MDR Article 22(3)(c) that contain a component/product falling under the current GPSD should be particularly attentive to the requirements of the new GPSR.
This regulation shall apply from 13 December 2024.
Status: in the pipeline
AI legislation
Especially relevant for software manufacturers are the Proposal for Artificial Intelligence Act and the Proposal for AI Liability Directive.
AI Act proposed by the European Commission in April 2021 is the first horizontal legislation on artificial intelligence in Europe and establishes a new risk approach. From unacceptable risks (AI not permitted in the EU) to the highest risk, medical devices fall under.
- Impact (direct for certain types of devices): For medtech manufacturers of AI systems, it is essential to be aware that requirements under the AI Act will be checked by the Notified Body that assesses the device against the MDR. There will be a single Declaration of Conformity for both regulations and a single CE mark.
The Act is currently still in the legislative procedure, however, on 9 December 2023 a political agreement was reached between the Parliament and the Council. We expect its adoption by the end of 2023/beginning of 2024, with a transitional period of 24 months. The AI Act is expected to become applicable in 2026.
Revised Pharmaceutical Regulation
In April 2023. the European Commission proposed a new Directive and Regulation to regulate medicinal products and is currently in the preparatory phase in the European Parliament.
- Impact (direct for certain types of devices): Once applicable, assessing changes per the existing regulatory framework will be essential. Especially for medical devices intended to administer a medicinal product, which forms a single integral product intended exclusively for use in the given combination and is not reusable. That single integral product is governed by pharma legislation, as applicable. Nevertheless, MDR GPSR applies to the device part of the single integral product (MDR Article 1(9)).
Ecodesign for Sustainable Products Regulation
In March 2022, the European Commission proposed a new Regulation tackling sustainability and ecodesign requirements of products placed on the EU market. Compared to the existing framework, the scope of products has been broadened and includes medical devices.
- Impact: When it comes to medical devices and IVDs, the Regulation applies. However, it is noted that the Commission should consider the need to not negatively affect the health and safety of patients and users when establishing ecodesign requirements related to, among others, durability, reliability, reusability, upgradability, and reparability.
The Regulation is currently awaiting Parliament’s position in 1st reading (Council adopted the position in May 2023, EP plenary planned for 10 July 2023), and once agreed, the negotiations between the Council and the Parliament will start.
Liability
Regarding liability, there are two new legislative acts in the pipeline of the EU decision-makers with an impact on the medtech industry providing AI systems.
The first one is the new AI Liability Directive which will cover claims that do not fall under the existing Product Liability Directive (PLD) and aims at harmonizing national rules linked to AI liability.
The European Commission released the Proposal in September 2022 and is currently awaiting a committee decision in the European Parliament.
- Impact: for AI systems
On the other hand, the Proposal for a revised Product Liability Directive for defective products builds on the existing framework and extends non-contractual civil liability rules to artificial intelligence. Moreover, it gives the same level of protection against defective products from EU and non-EU manufacturers.
The European Commission Proposal was published in September 2022 and is now awaiting Parliament’s position in 1st reading. The Council adopted its negotiation position in June 2023.
- Impact: for defective devices
You can find links to relevant laws in the MDR other applicable law and IVDR other applicable law sections of our Library of Documents.
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