GPSR Service
Your Trusted Responsible Person for General Product Safety Regulation Compliance
With the European Union’s new General Product Safety Regulation (GPSR) taking effect, manufacturers and distributors face increased responsibilities to ensure product safety across the EU market. MedNet EC-REP GmbH is here to help. As an established EU Authorized Representative with expertise in regulatory affairs, we offer a comprehensive Responsible Person service tailored to GPSR compliance.
GPSR and General Products: Ensuring Consumer Safety Across the EU
The General Product Safety Regulation (GPSR) is designed to safeguard consumers by setting high standards for the safety of general products in the European Union. This regulation applies to all consumer goods that are not already covered by specific EU laws or regulations, ensuring that products in the market are safe for everyday use.
What is Covered Under GPSR?
GPSR applies to a wide range of products, including:
- Household goods: Appliances, furniture, and decor
- Electronics and gadgets: Mobile phones, computers, and personal tech
- Toys and games: Products for children, including playsets, dolls, and puzzles
- Personal care products: Cosmetics, skincare items, and hair care tools
- Sporting goods and equipment: Bikes, fitness equipment, and outdoor gear
- Automotive accessories: Car seats, safety gear, and other vehicle-related products
If a product is intended for use by consumers and does not fall under a specific EU regulation (like food or medical products), it is generally considered to fall within the scope of the GPSR.
Why Appoint MedNet EC-REP as Your GPSR Responsible Person?
Compliance Peace of Mind
Rely on our in-depth understanding of GPSR requirements to safeguard your brand’s compliance.
Efficient EU Market Entry
Simplify your entry into the EU market with our streamlined Responsible Person service.
Dedicated Regulatory Support
As part of our commitment to quality service, we offer responsive support to handle any regulatory questions or compliance needs.
Understanding GPSR Applicability for Medical Devices and IVDs
While medical devices (MDs) and in vitro diagnostic devices (IVDs) are primarily governed by the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), certain circumstances can also bring them under the scope of the General Product Safety Regulation (GPSR). GPSR, aimed at ensuring the safety of general consumer products, may apply if certain conditions related to consumer accessibility and product use are met.
Intended Use as Consumer Products
If a medical device or IVD is designed, marketed, or intended for use as a consumer product, it may fall under GPSR regulations. In other words, if the product is meant to be used by consumers without the supervision of healthcare professionals, and is accessible to the general public, GPSR’s safety requirements will likely apply in addition to MDR or IVDR. This is especially relevant for home-use diagnostic tests, certain wellness monitoring devices, and other medical products commonly used by consumers.
Sales Channel Accessibility
GPSR may also apply to medical devices and IVDs based on how and where they are sold. If a product is sold online or through other forms of distance sales that are accessible to consumers, GPSR may be relevant. When the product is available on consumer-accessible platforms or channels, GPSR’s consumer safety standards ensure that these products meet safety criteria suitable for non-professional settings.
When GPSR Is Not Applicable
Conversely, if a medical device or IVD is strictly for professional use, and not accessible to consumers through online or other distance sales channels, GPSR generally does not apply. For example, if a product is used exclusively in clinical settings or requires specialized knowledge or handling, it is likely that only MDR or IVDR will govern its safety compliance requirements.
Is GPSR Applicable to Your Products?
Let MedNet EC-REP GmbH help you navigate the new regulations.
Frequently Asked Questions (FAQs) About the General Product Safety Regulation (GPSR)
GPSR applies to any consumer product that is not regulated by a specific EU law. This can include household goods, electronics, toys, and products that are sold directly to consumers through online or retail channels.
If your product is intended for use by the general public and is accessible to consumers (e.g., via online sales, retail, or direct-to-consumer distribution), it is likely considered a consumer product under GPSR.
While medical devices are primarily regulated by the Medical Device Regulation (MDR), if the device is marketed for general consumer use and is sold through consumer-accessible channels, GPSR may also apply.
Manufacturers must ensure that their products meet the safety requirements of GPSR, provide adequate instructions, and keep documentation that proves the product's safety. Additionally, manufacturers must report any safety incidents related to their products.
Yes, if your company is based outside the EU and you sell products covered by GPSR in the EU, you must appoint a Responsible Person (RP) to manage safety issues, documentation, and communication with EU authorities.
To ensure compliance, conduct thorough safety assessments, maintain up-to-date documentation, monitor the market for safety risks, and appoint a Responsible Person if necessary.