Product Safety Regulation (EU) 2023/988: New standards for safe products in Europe!

The new Product Safety Regulation (EU) 2023/988 has been in force since 13 December 2024 and replaces the previous Directive 2001/95/EC on general product safety and the national Product Safety Act (ProdSG). The regulation is directly applicable in all EU member states and creates a standardised set of safety regulations for consumer products. It supplements existing regulations such as the MDR (EU) 2017/745 and sets new standards for product safety, market surveillance and traceability. Health-related consumer products such as fascia rollers, massage guns and yoga mats are particularly affected. Even though these products are usually not classic medical devices, they are now subject to stricter regulatory requirements. Manufacturers, importers and distributors must now ensure that their products are not only MDR-compliant, but also fulfil the extended safety and transparency requirements of the new product safety regulation. This article provides a comprehensive overview of the key changes, shows the additional requirements for manufacturers, importers and distributors of medical devices and health-related consumer products and the steps they must now take to remain compliant.

Whether hedgehog balls, dumbbells, fitness bands, fascia rollers or massage guns - health-related consumer products have long been an integral part of our everyday lives. They are used for muscle relaxation, pain therapy, prevention and rehabilitation and are mainly designed for home use. However, it is precisely this fact that poses a regulatory challenge:

While classic medical devices, such as clinical thermometers, inhalers or blood pressure monitors, are already strictly regulated and embedded in a comprehensive safety and quality control system, many health-related products are subject to less stringent requirements. The new Product Safety Regulation (EU) 2023/988 closes this regulatory gap and introduces standardised, stricter safety requirements for almost all products placed on the market within the EU - including consumer goods such as fitness equipment, pillows or massage tools.  It defines clear requirements to ensure the safety of products and improve consumer protection. It sets new standards for the responsibilities of manufacturers, importers and distributors and strengthens market surveillance by national authorities. In addition, it creates new types of economic operators who are subject to special obligations: Fulfilment service providers and online marketplaces.

The goal is clear: a high, EU-wide harmonised level of safety for all consumer products, regardless of whether they are classified as medical devices or not.

The most important changes to the Product Safety Regulation (EU) 2023/988!

The previous Product Safety Directive 2001/95/EC (GPSD) formed the basis for product safety requirements in the EU for over two decades. Its aim was to set uniform standards for consumer products and keep dangerous products off the market. However, rapid technological developments, new forms of distribution such as online retail and increasingly globalised supply chains have pushed the old directive to its limits.

There were growing safety concerns, particularly in the area of health-related consumer products and medical devices. While medical devices were covered by the MDR (EU) 2017/745) and IVDR (EU) 2017/746, many related products - including massage devices, beds, fitness bands and balance cushions - were not previously subject to standardised regulation. The lack of traceability of such products and uncertainties regarding their safety led to an increased risk for consumers.

The new Product Safety Regulation (GPSR, EU 2023/988) replaces the GPSD and introduces binding, standardised safety requirements that are directly legally binding for all market players. It supplements existing regulations for medical devices and ensures that health-related products with a consumer focus are also traded under clear rules.

Key improvements compared to the GPSD

1.    direct applicability in all EU Member States

• In contrast to Directive 2001/95/EC, the new regulation is directly applicable law and does not have to be transposed into national law first.
• This ensures a standardised legal situation throughout the EU and prevents different national regulations.

2.    extended requirements for digital and smart products

• In addition to physical products, software-controlled and AI-supported products must also fulfil stricter safety requirements.
• Additional risk assessments apply to digital health products (e.g. smart massage devices, connected wearables), particularly with regard to data protection, cybersecurity and functionality.

3.    stricter reporting and recall obligations

• Companies are now obliged to report safety-related defects to the EU market surveillance authorities within 2 working days.
• Immediate action must be taken for dangerous products, including recall, replacement or reimbursement for affected consumers.

4.    increased transparency for consumers

• Companies must provide products with clear labelling (serial numbers, manufacturer information, safety instructions).
• Stricter information obligations apply, particularly in online retail - product descriptions must contain full manufacturer and safety information.

5.    standardised reporting system without national solo efforts

• If products do not fulfil their safety requirements, reports are submitted via an EU-wide safety business gateway.

Extended requirements for medical devices and health-related products!

Even though medical devices are already regulated under the MDR, the GPSR brings with it new requirements for health-related consumer products that manufacturers, importers and distributors must be prepared for.

1.    more stringent risk analysis and product safety assessment

• Manufacturers must now not only ensure that their products fulfil the general safety requirements, but also carry out a comprehensive risk analysis that takes particular account of special consumer groups such as children, the elderly or people with health restrictions.
• In addition to mechanical, chemical and biological risks, manufacturers must now also document cyber safety risks, risks due to software malfunctions and interoperability risks in their risk assessment.
• The documentation requirements for post-market surveillance (PMS) are being strengthened, meaning that manufacturers are obliged to record and analyse safety data on an ongoing basis.

2.    extended traceability and labelling obligations

• Products must bear unique identification numbers (serial, batch or type numbers) to ensure full traceability. This is harmonised with the requirements of Unique Device Identification (UDI) under the MDR.
• Manufacturers must ensure that importers and distributors can document all relevant data on their products and make it available to market surveillance authorities on request.
• The labelling requirements for products sold online have been significantly tightened. Retailers and platform operators must ensure that full manufacturer details, identification numbers and safety information are clearly visible.

3.    stricter requirements for online retailers and platform operators

• Online marketplaces are defined as economic operators for the first time under the GPSR and must ensure that no unsafe or inadequately labelled products are sold on their platform.
• Operators of online marketplaces can be held directly liable for infringements and must introduce systems for preventive product monitoring.

4.    stricter reporting obligations and faster recall processes

• Companies must now report unsafe products to the EU Safety Gate within 2 working days.
• In the event of a recall, consumers must be actively informed and companies are obliged to offer either a repair, replacement or refund.
• Authorities are given extended powers to order product recalls and can enforce measures against non-compliant products more quickly.

New roles with additional responsibilities!

In addition to the traditional economic players of manufacturer, importer, authorised representative and retailer, two further roles have been created: online marketplaces and fulfilment service providers.

• Online marketplaces are already part of our everyday lives. They are platforms that provide interfaces between consumers and companies to sell products.
• Under the GPSR, online marketplaces must ensure that no unsafe or inadequately labelled products are sold on their platform.
• You set up your platforms so that businesses provide consumers with all the necessary safety information
• Operators of online marketplaces can be held directly liable for infringements and must introduce systems for preventive product monitoring.

Fulfilment service providers are providers of storage and packaging services (excluding postal and parcel services). They carry out at least two of the following activities for their clients: Warehousing, packaging and shipping activities.

• Fulfilment service providers maintain a system for the traceability of the managed products
• You support other economic operators in the implementation of corrective actions

Recommendations for manufacturers, importers and retailers!

The new requirements of the GPSR entail comprehensive changes for the entire value chain. To avoid regulatory risks, companies should prioritise the following measures:

• Review the product portfolio: Which products fall under the new regulations? Accessories or replacement products should also be closely scrutinised.
• Adapt labelling and online offerings: All products must contain the required labelling and online descriptions must be adapted. Optimise supplier management: Establish clear contractual regulations to ensure that all players in the supply chain comply with the new obligations.
• raining for employees: Those responsible for quality assurance, regulatory affairs and sales should be familiarised with the new requirements.
• Establish efficient recall and reporting systems: A fast and transparent system for identifying and reporting unsafe products minimises risks.

TentaConsult - your partner for a successful implementation of the GPSR / Act now to stay compliant!

The implementation of the new requirements of the GPSR requires detailed knowledge of the regulation as well as an adaptation of existing compliance processes. TentaConsult supports manufacturers, importers, distributors and suppliers of medical devices and health-related consumer products in efficiently implementing the new requirements and minimising regulatory risks.

Our services include

• Regulatory consulting and gap analyses to identify compliance gaps between GPSD, GPSR and MDR
• Training and sensitisation for internal teams regarding new requirements for product safety, documentation, risk management and market surveillance
• Support in the creation and adaptation of technical documentation in accordance with the new GPSR requirements
• Implementation and optimisation of recall and reporting processes

Use our expertise to prepare for the new regulatory challenges and offer your products on the European market in compliance with the law. Get in touch with us today!