The European regulatory landscape is a very dynamic environment, with many changes affecting both manufacturers and consumers constantly. For manufacturers, staying up-to-date on the most recent news is crucial to ensure compliance and safety. In 2024, we can expect some major regulatory news that impact manufacturers of different products. While Obelis keeps you informed regularly, there are some selected events coming this year for which manufacturers and brand owners can already start preparing.
Three highlights of the medical devices industry
In 2023, the Medical Devices Regulation and In Vitro Diagnostics Relation (MDR and IVDR) were objects of big headlines in the industry. With the new extensions being the most impactful change for legacy devices, the overall timeline for the Regulations’ implementation was adjusted to new deadlines. This year will bring some important landmarks for manufacturers:
- What is probably the most expected news is the publication of the EU Artificial Intelligence (AI) Act, which is the first comprehensive law regulating AI, including medical devices with AI embedded or AI system medical devices.
- In the first months of 2024, sponsors of clinical investigations of Annex XVI devices benefitting from the extended transitional period still have time to submit a clinical investigation application. Between June and December 2024, the sponsor must have received an authorisation from a Member State to start the clinical investigation and by December 2024, the clinical investigation must start.
- Given the position adopted by some Member States on the IVDR transition, manufacturers of IVDs might expect some news on the legacy deadlines, especially for class D IVDs, as well.
Cosmetics industry: more ingredients’ restrictions coming
Last year was characterised by many ingredients’ bans and restrictions. With the application of one Omnibus Act and a new regulation on the labelling of fragrance allergens, cosmetics brand owners had to promptly adapt their products to the new changes. 2024 started with the application of two substances’ restrictions, announced already in 2022. From 1 January 2024, Butylated Hydroxytoluene (BHT) and Acid Yellow 3 can no longer be released for distribution or use above the new restrictions.
Around the beginning of 2024, we can expect the publication of a new regulation which will impose new restrictions. The restrictions concern, among other ingredients, the following forms of Vitamin A: Retinol, Retinyl Acetate, and Retinyl Palmitate.
New Regulations on general products, construction products, and toys
The application of the new General Products Safety Regulation (GPSR) is among the most awaited events of 2024. From 13 December 2024, the new GPSR will replace the Directive, significantly impacting products without specific legislation. Together with explicit requirements for online selling, the GPSR includes stricter market surveillance, a more efficient product recall system, and – most importantly for non-EU manufacturers – the obligation for non-EU manufacturers to have one economic operator based in the European Union.
During 2024, we can expect developments in the context of the Construction Products Regulation (CPR) revision and the new Toy Safety Regulation (TSR) proposal. The European Commission will likely publish the final text of the revised CPR. The revision became necessary to address several gaps in the current regulatory framework, such as the environmental and climate impact, the internal market functioning, and certain safety and health requirements. Subject to negotiations, the Commission will probably publish the report on the proposed TSR in the first half of 2024. The indicative time for the report’s vote should be 13 February 2024.
How manufacturers and brand-owners can stay up-to-date
Staying up-to-date about the latest regulatory news is crucial for manufacturers of all products to ensure compliance and avoid any sanction or products’ recall. For manufacturers of medical devices, following regulatory updates is a mandatory requirement of the Quality Management System (QMS). Cosmetics brand owners, instead, must pay particular attention to new ingredients’ bans and restrictions coming into force, sometimes with relatively short deadlines.
Obelis offers different solutions to inform manufacturers about regulatory news:
- MDlaw.eu is the information platform on medical device legislation in the European Union, United Kingdom, and Switzerland.
- COSlaw.eu is the information platform on cosmetics legislation in the European Union, United Kingdom, and United States.
- PRODlaw.eu is the information platform on European law about construction products, electronics, general safety products, machinery, motor vehicles, marine equipment, pressure equipment, personal protective equipment, equipment for potentially explosive atmospheres, and toys.
- With Obelis regulatory content service, manufacturers can indicate their topics of interest and receive periodically tailored regulatory updates.
All Obelis clients receive campaigns, newsletters, consultancy, and platforms’ access to be easily and promptly informed about any changes that might impact their compliance.
Do you want to know more about what consultancy and representation services Obelis offers? Contact us!
Simona Varrella
Regulatory Intelligence & Innovation
16.01.2024
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