It is the “default directive” – anything which is nothing = GPSD – and it applies to all the products in so far as there are no specific provisions with the same objective in rules of Community law governing the safety of the products concerned. Where products are subject to specific safety requirements imposed by a specific Community legislation, this Directive applies only to the aspects and risks or categories of risks not covered by those requirements. (e.g Toys, LVD, PPE etc.). Finally, the GPSD established the Rapid Alert System (RAPEX – information on dangerous goods).
Steps to compliance:
- Products under GPSD do not bear the CE marking and No Pre-Market Notification is needed.
- Manufacturer to asses if a product is GPSD (fully or complementary with other Regulation)
- Understand Conformity Route
- Find applicable EU or national requirements and related applicable International or National Standards (or self-assess if none)
- Risk Assessment (internal and external)
- Post Market Surveillance (PMS) and Corrective And Preventive Action (CAPA) plan
- Technical Documentation creation
Considering the abovementioned requirements, it is evident that GPSD compliance requires an elevated level of attention and preparation from the Manufacturers. Obelis is building experience on GPSD from the moment this law was published by the Commission. Would you like to better understand the compliance steps and avoid any possible issues on the Market, please do not hesitate to contact us. Our experts will be delighted to serve you with our GPSD Authorized Representatives services and Trainings.