European certification, also known as European Сonformity (CE) marking, is a mandatory conformity marking for products sold within the European Economic Area (EEA). The CE marking indicates that a product meets the health, safety, and environmental protection standards set by the European Union (EU). In 2022, the European certification system will undergo some changes that businesses and manufacturers need to be aware of.
One of the most significant changes to the European certification system in 2022 is the introduction of the new EU Regulation 2019/1020 on market surveillance and compliance of products. This regulation aims to strengthen market surveillance and enforcement of product safety rules and establish a harmonized framework for market surveillance across the EU.
Under the new regulation, manufacturers and importers will have increased responsibilities and obligations to ensure their products meet EU standards and safety requirements. This includes carrying out risk assessments and maintaining technical documentation demonstrating compliance with EU regulations.
Another change to the European certification system in 2022 is the transition to the new Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR), which will replace the existing Medical Device Directive (MDD) and In-Vitro Diagnostic Directive (IVDD) respectively. The new regulations aim to increase the safety and effectiveness of medical devices and in-vitro diagnostic devices and improve the traceability of these products throughout their lifecycle.
To comply with the new MDR and IVDR regulations, manufacturers of medical devices and in-vitro diagnostic devices will need to carry out additional assessments and obtain certification from notified bodies, which are independent organizations designated by EU member states to assess the conformity of products.
Overall, the European certification system in 2022 will focus on strengthening market surveillance and enforcement of product safety rules and improving the safety and effectiveness of medical devices and in-vitro diagnostic devices. Businesses and manufacturers should be aware of these changes and ensure they are complying with the latest EU regulations to avoid any potential legal or financial consequences.