The Regulation applies to: (1) products placed or made available on the market, provided there are no specific provisions in Union law with the same objective governing the safety of the products concerned;
(2) for products subject to Union harmonisation legislation, only those aspects, risks or categories of risks not covered by that legislation;
(3) new, used, repaired or reconditioned products, except products clearly marked as needing repair or reconditioning before use.
Products not covered: medicinal products, food, feed, living plants and animals, animal by-products and derived products, plant protection products, equipment on which consumers ride or travel that is operated directly by a service provider in the context of a transport service, certain aircraft, antiques, etc.
Download Regulation (EU) 2023/988 at: https://eur-lex.europa.eu/search.html?scope=EURLEX&text=%EF%BC%88EU%EF%BC%892023%2F988&lang=en&type=quick&qid=1754546369977
Summary of the main content of EU 2023/988, in one chart:
New requirements of EU 2023/988 that companies must take seriously
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Obligations of online marketplace providers (such as Amazon, eBay and TikTok Shop):
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Register on the “Safety Gate portal”, designate a single point of contact for communicating with authorities and consumers on product safety, establish internal product safety processes, comply promptly with relevant requirements, and act on orders from market surveillance authorities to remove content relating to dangerous products – taking action within two working days of receiving an order and informing the authority. Notices relating to product safety must be handled within three working days of receipt.
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Design and organise the online interface so that traders can provide product safety information and consumers can easily access it in product listings.
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Cooperate with market surveillance authorities, traders and relevant economic operators to eliminate or mitigate product risks, e.g. by informing consumers of recalls, cooperating in recalls and reporting dangerous products and accidents.
2. The Safety Gate portal maintained by the European Commission: it enables economic operators and online marketplace providers to provide relevant information to market surveillance authorities and consumers, and the Commission will issue guidance on the practical implementation of the portal.
3. Obligations of authorised representatives: perform specified tasks under the manufacturer’s written mandate, such as providing information and documentation demonstrating product safety at the request of market surveillance authorities, informing the manufacturer when they consider a product dangerous, and reporting to the competent national authorities.
4. Recall notice template: see Article 36 of EU 2023/988. For remedies in the event of a product safety recall, see Article 37 of EU 2023/988.
On the EU market, ensuring products comply with the relevant harmonised standards is essential. To quickly find the EU harmonised standards for a specific product, you can use the following sources:
1. European Commission website:
Visit https://ec.europa.eu/growth/single-market/standards/harmonised-standards_en
2. EUR-Lex database:
Website https://eur-lex.europa.eu/
This is the key database for finding the official texts, amendment history and current consolidated versions of EU Regulations and Directives.
3. CEN-CENELEC website:
https://www.cenelec.eu/
Here you can look up implementation details and version status of standards. Find the search section on the website.
4. Official Journal of the European Union
Website: https://eur-lex.europa.eu/oj/direct-access.html?type=L
Official publication of EU legislation.
Implementation recommendations for companies
1. Regularly update risk assessments and technical documentation;
2. Ensure declarations of conformity are complete and archived long-term;
3. Ensure information displayed on online platforms meets the new requirements;
4. If you are a manufacturer outside the EU, be sure to appoint a compliant EU representative;
5. Become familiar with the Safety Gate portal reporting process and establish an emergency response mechanism.
Summary
This is a series of educational articles introducing FDA, NMPA, GMP, CE MDR/IVDR and MDSAP regulations and standards. Everbiz is happy to share medical device expertise with industry clients and hopes our extensive hands-on experience in quality systems and product registration will be of help to you. Let’s contribute together to the development of the medical device industry.
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