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- 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
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Regulation (EU) 2016/425 is the Personal Protective Equipment (PPE) Regulation, which sets out the requirements for the design, manufacture, and placing on the market of personal protective equipment within the European Union (EU) and European Economic Area (EEA). The regulation aims to ensure a high level of health and safety protection for users of personal protective equipment while facilitating the free movement of such equipment within the EU market.
Here's an overview of the certification process for compliance with Regulation (EU) 2016/425:
Scope Determination
Determine whether the product falls within the scope of the PPE Regulation. The regulation applies to a wide range of personal protective equipment designed to protect users against health and safety risks, including protective clothing, helmets, gloves, eye and face protection, respiratory protective devices, and more.
Identification of Essential Requirements
Identify the essential health and safety requirements set out in Annex I of Regulation (EU) 2016/425 that are applicable to the personal protective equipment. These requirements cover factors such as design, construction, materials, performance, ergonomics, and marking to ensure the effectiveness and safety of the PPE.
Risk Assessment
Conduct a risk assessment to identify and evaluate potential hazards associated with the personal protective equipment throughout its lifecycle. This includes assessing risks related to mechanical, chemical, biological, radiation, and other hazards, as well as risks associated with improper use or maintenance of the PPE.
Design and Manufacturing Compliance
Design and manufacture the personal protective equipment in accordance with the essential requirements of the PPE Regulation. This may involve following harmonized standards, technical specifications, or other recognized methods of compliance.
Technical Documentation
Compile technical documentation demonstrating compliance with Regulation (EU) 2016/425. This documentation should include information about the design, construction, materials, testing, and performance of the personal protective equipment, as well as risk assessments and instructions for use.
Conformity Assessment
Assess conformity with the requirements of the PPE Regulation through various conformity assessment procedures. This may include self-assessment based on internal production control, involvement of a notified body for assessment of full quality assurance, or type examination of individual products.
CE Marking
Affix the CE marking to the personal protective equipment once compliance with Regulation (EU) 2016/425 has been demonstrated. The CE marking indicates that the product meets the essential requirements of all applicable EU regulations, including the PPE Regulation.
Declaration of Conformity
Prepare a Declaration of Conformity stating that the personal protective equipment complies with the requirements of Regulation (EU) 2016/425. The Declaration of Conformity should be kept on file and made available to authorities upon request.
Market Surveillance
Authorities in EU member states conduct market surveillance activities to ensure that personal protective equipment placed on the market complies with the requirements of Regulation (EU) 2016/425. This may include inspections, testing, and enforcement actions to address non-compliant products.
Compliance with Regulation (EU) 2016/425 is essential for manufacturers seeking to market personal protective equipment within the European Union and European Economic Area.
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.
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