General Product Safety Regulation

 

The General Product Safety Regulation (GPSR) establishes essential requirements for consumer products that are not covered by specific sector legislation (e.g., toys, cosmetics, medical devices) to protect consumer health and safety while ensuring the proper functioning of the internal European market.

The GPSR provides that economic operators shall place or make available on the market only safe products. Products are presumed to be in conformity with this general safety requirement if they either conform to relevant European standards as far as the risks and risk categories covered by those standards are concerned, or in their absence, to national requirements (which shall be compliant with EU law). 

Manufacturers, who may mandate an authorised representative to perform their obligations on their behalf, are required to draw up technical documentations and to carry out internal risk assessments taking due account of the precautionary principle and various aspects, such as:

  • The characteristics of the product
  • Its effects on other products & vice versa
  • The categories of consumers using it
  • Its presentation
  • Its appearance


While manufacturers are the primary economic operators in charge with the compliance of the general safety requirements, every actors within the supply chain (importers and distributors) are responsible for checking that the upstream supply chain did comply with their obligations under the GPSR.

In case the product cannot be presumed safe (because of the absence of relevant European standard and national requirements), economic operators shall also rely on:

  • International standards and agreements
  • Voluntary certification schemes, product safety codes of good practice
  • European Commission recommendations or guidelines
  • State of the art and technologies
  • Reasonable consumer expectation


Most Absorbent Hygiene Products (baby diapers, menstrual products) fall entirely within the scope of the GPSR, while incontinence products are covered by the Medical Products Regulations. Where products are subject to specific safety requirements imposed by Union law, such as incontinence products, the GPSR applies only to those aspects and risks or categories of risks which are not covered by those requirements.

Enhanced Obligations for Economic Operators

Under the new regulation, manufacturers are required to provide consumers with detailed information on potential risks associated with their products and take appropriate measures to prevent such risks. New requirements have been introduced to ensure product traceability throughout the supply chain.

To comply with the GPSR, manufacturers must conduct a thorough risk assessment of their products. The results of this assessment must be documented and included in an in-house product dossier that can be presented to national authorities during enforcement actions.

Economic operators are required to cooperate with market surveillance authorities, ensuring that only safe products are available on the market. They must also maintain proper documentation to help trace dangerous products, if necessary.

Digital Transformation and Online Marketplaces

The GPSR introduces new provisions aimed at addressing the challenges posed by online sales and digital marketplaces. E-commerce platforms are now required to verify the safety of products sold through their services, ensuring they meet the same standards as those in brick-and-mortar stores.

Strengthened Role of Member States

Under the GPSR, Member States continue to have a central role in enforcing product safety. They are responsible for appointing authorities to carry out market surveillance and enforcement actions. Additionally, they must ensure that penalties for non-compliance are strengthened and aligned across the EU.

The GPSR also grants surveillance authorities expanded monitoring and intervention powers to enhance the efficiency of enforcement measures, allowing them to issue recalls or bans on unsafe products more swiftly.

Improved RAPEX System (Now called Safety Gate)

The regulation maintains the rapid alert system (previously known as RAPEX, now referred to as Safety Gate) to quickly share information about dangerous products among Member States and the European Commission. The system ensures that relevant authorities are informed promptly when a dangerous product is identified.

Safety Gate allows for the exchange of rapid alert notifications between the EU and non-EU countries. 

New Emergency Measures

The GPSR enhances the emergency measures that the Commission can take in response to serious product risks. Under the new regulation, the Commission can adopt formal decisions requiring Member States to take immediate actions, such as banning unsafe products, recalling them from consumers, or withdrawing them from the market.

 

For more information, read the EDANA guidance document for the nonwovens and related industry on the implementation of the GPSR and visit the European Commission's website on product safety and consumer protection.
GPSR EDANA GUIDELINES GPSR Annex 1 GPSR Annex 2 GPSR Annex 3
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The new regulatory framework for medical devices in European Union is governed by two main references:

 

The Regulations ‘entered into force’ on 25 May 2017 with three and respectively 5-year transition period.

Warning against counterfeit products

What are the conformity modalities?

In the EU, a system that focuses on the level of potential hazard inherent in the type of device concerned is the key to prove the medical devices are safe and effective. The classification of medical devices is outlined in Article 51 of the Medical Devices Regulation (EU) 2017/745 and Article 47 of the In Vitro Diagnostics Medical Devices (EU) 2017/746, ranging from low risk to high risk.

Medical devices have to undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. The conformity assessment depends on the risk class.  Class I medical devices (excepting those that are re-useable, require sterilization or have a measurable function) can be marketed based on self-certification. Moderate to high risk class devices necessitate an audit of the manufacturer’s quality system by a Notified Body and, depending on the type of device, a review of technical documentation of the manufacturer on the safety and performance of the device.

Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment. 

Ensuring compliance of medical devices with relevant legal requirements

Article 10 of the MDR and the IVDR comes with a set of obligations for manufactures, such as:

  • Confirm that the product is a medical device according to the Annex VIII of the MDR and IVDR)
  • Ensure general safety and performance requirements are met, including for labelling and technical documentation and quality management systems (Annex I of the MDR and IVDR)
  • Meet the requirements for clinical evidence (Annex XIV of the MDR and IVDR)
  • Appoint a person responsible for regulatory compliance in place (Article 15 of the MDR and IVDR)
  • Ensure economic operators in the supply chain are compliant and sufficient financial coverage is in place, in respect of a manufacturer’s potential liability (Article 10 of the MDR and IVDR)
  • Ensure the new vigilance reporting timescales are met and that an annual periodic safety update report is created (Chapter VII, Section 1 and 2 of the MDR and IVDR)

Medical devices and nonwovens

Nonwovens are present in almost all the daily use applications, some of them being essential healthcare products. An extensive list of medical applications is available here. 

The new regulatory framework on medical devices and in vitro diagnostic medical devices significantly impacts the entire supply chain. Manufacturers must ensure that products conform to the regulations at every stage. There are additional and more stringent requirements for risk management and hazardous substances, supply chain obligations, clinical evidence, labelling. post market clinical follow up and safety reporting, traceability (Unique Device Identification (UDI) system) and transparency (Eudamed database). Changes in the regulatory obligations of operators across each product supply chain include establishing and maintaining quality system requirements for all those involved in the design, manufacture, inspection or testing of the product or any components used therein.

EDANA closely follows up and advises its members on the impact of the new Regulations and work to support companies across the entire supply chain in complying with the complex regulatory framework.

EDANA highlights the value and contribution of the nonwovens and related industries that play a major role in producing materials essential for patients, healthcare professionals and society.