Who is affected by the new regulation?
The regulation is the successor of previous directives by which the EU tries to ensure market surveillance of non-food products on the EU market that do not endanger European consumers and workers.
The new regulation will affect the following economic operators:
- Designers
- Manufacturers
- Importers
- Exports
- Distributors
Curious about what your obligations and responsibilities are? Consult our CE experts.
In the EU the CE marking for product safety is based on a system of inadequate and limited market surveillance. Due to the current surveillance system in place the EU has limited resources and capacity in pursuit of a safe environment for its citizens. Though, from now on this is going to change through the new implemented Market Surveillance Regulation.
The essence of the new regulation is embedded in Article 4 which prescribes a mandatory EU-address which is designated as an information hub of the product concerned.
This paves the road towards the responsible or authorized party of the product, thus easy to trace for European authorities. This is of high importance due to the continuous growth of internet-shops and e-commerce, which often are harder to trace.
What products are impacted?
This regulation affects a wide range of industries and a huge variety of products including machinery, medical devices, electronics. See a summary of the list of these product categories below:
- construction products (CPR)
- eco-design of energy-related products (EDD)
- electromagnetic compatibility (EMC)
- equipment and protective systems intended for use in potentially explosive atmospheres (ATEX)
- low voltage electronics (LVD)
- machinery (MD)
- measuring instruments (MID)
- medical devices (MDR)
- personal protective equipment (PPE)
- pressure equipment (PED)
- radio and telecommunications terminal equipment (RED)
See the full list over here.
Is your product subjected to CE certification? Ask our CE experts here.
Key takeaways of the Market Surveillance Regulation
For Business to Consumer (B2C) trade on the internet, there is no formal responsibility for the supplier meaning the consumer is seen as the importer and responsible for the compliance.
This entails that the consumer should be aware and ensure that the product they buy online complies with the applicable EU legislation. This is an unrealistic expectation of consumers without incentive and limited knowledge of the EU regulatory framework.
The new regulation would change that because it requires non-EU vendors to have an Authorized Representative in the EU, and makes the fulfillment service provider responsible when there is no representative. Producers outside the EU have one and a half years to comply with the new regulation.
The regulation will enter into force at the end of 2020 beginning 2021. Apart from the EU-address requirement, the new market surveillance regulation enhances the way surveillance is conducted by:
- displaying rules and procedures for economic operators
- empower market surveillance of products covered by EU legislation
- providing a framework for EU border controls
With offices in the US, the Netherlands, Germany and China we offer tailored solutions for all complexities our clients encounter. We dedicate our services to improve the safety level for products of our clients and subsequently for a safer world for everyone.