- Home
- About
- Certification
- Product Certifications
- CE Mark Certification
- Medical Devices & IVDS
- Other Directive & Regulations
- LVD – Low Voltage Directive LVD2014/35/EU
- MCD | Directive Machinery_2006/42/CE
- DLS – Directive Lifts and Safety Components for Lifts_2014/33/UE
- EMC | Directive 2014/30/UE Electromagnetic Compatibility
- RED | Directive 2014/53/UE Radio Equipment Directive
- NOISE | Directive 2000/14/CE Noise
- PED – Directive 2014/68/UE
- ATEX – Directive 2014/34/UE
- Toys – Directive 2009/48/CE
- PPE – Regulation (EU) 2016/425
- GAR – EU Regulation 2016/426
- PED – Directive 2014/68/UE
- CE Mark Certification
- Inspection
- Public Documents
- Contact
PRNS would serve CE mark certification services of Medical Devices, IVDs and other directive and regulations through Collaboration/Partnership Agreement with a European Notified Body.
European Union aim to protect consumers, ensure fair competition, and facilitate the free movement of goods within the EU Single Market. Compliance with EU regulations and standards is essential for manufacturers seeking to access European markets and maintain the safety and quality of their products. In the European Union (EU), product certifications play a crucial role in ensuring the safety, quality, and compliance of products placed on the market. There are various types of product certifications and conformity assessment procedures established under EU regulations to demonstrate compliance with applicable standards and requirements.
CE Marking
CE marking is a mandatory conformity marking for certain products placed on the market in the European Economic Area (EEA), indicating that they comply with relevant EU regulations and meet essential health, safety, and environmental requirements. Products subject to CE marking include machinery, electrical equipment, medical devices, personal protective equipment, toys, construction products, and more.
Conformity Assessment Procedures
Depending on the type of product and applicable regulations, manufacturers may need to undergo various conformity assessment procedures to demonstrate compliance with EU requirements. These procedures may include self-assessment (for lower-risk products), involvement of a notified body (for higher-risk products), or a combination of both.
Notified Bodies
Notified bodies are organizations designated by EU member states to assess the conformity of certain products with relevant EU regulations. Notified bodies conduct conformity assessment procedures, including testing, inspection, certification, and quality management system audits. Their involvement is often required for products with higher safety risks.
Harmonized Standards
EU regulations often refer to harmonized standards, which are technical specifications adopted by European standardization organizations (e.g., CEN, CENELEC) to provide a presumption of conformity with essential requirements. Compliance with harmonized standards facilitates the CE marking process.
Contact
We will be happy to give you more information about our quality solutions. Please fill in this form to contact us, we will respond as soon as possible.
