CE Marking – (EU Regulations and Directives)

We are highly experienced in EU Product Regulations and Directives, and can help you effectively apply applicable Regulations and Directives to your products. 

We help you understand the EU’s perspective on “State-of-the-Art”, explain how it works, and how to address it.

We can notify you of important changes to EU Regulations and Directives.

Directive/Regulation Identification Title
MDD Directive 93/42/EEC Medical devices
MDR Regulation 2017/745/EU Medical devices
IVDR Regulation 2017/746/EU In vitro diagnostic medical devices
PPE Regulation 2016/425/EU Personal Protective Equipment
Cosmetics Regulation 1223/2009 Cosmetic Products
RoHS Directive 2011/65/EU Restriction on the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (lead free)
WEEE Directive 2012/19/EU Waste Electrical and Electronic Equipment
REACH Regulation 1907/2006/EC Registration, Evaluation, Authorization and Restriction of Chemicals
Battery Directive 2006/66/EC Batteries and Accumulators, and Waste Batteries and Accumulators
RED Directive 2014/53/EU Radio Equipment (including WiFi, Bluetooth)
GPSD Directive 2001/95/EC General Product Safety (including Repaired/Refurbished Products)
LVD Directive 2014/35/EU Low Voltage Electrical Equipment
EMC Directive 2014/30/EU Electromagnetic Compatibility
Machinery Directive 2006/42/EEC Machinery
Packaging and Waste Directive 94/62/EC
Packaging and Packaging Waste, amended by Consumption of lightweight plastic Carrier Bags
GDPR Regulation 2016/679/EU Protection of Natural Persons with Regard to the Processing of Personal Data and on the Free Movement of Such Data
Energy Labeling Regulation 2017/1369/EU Energy Labeling
ECO Design Directive 2009/125/EC Ecodesign for Energy Related Products
ECOlabel Regulation 66/2010/EC ECOlabel (Voluntary)
Labeling and Packaging Regulation 1272/2008/EC Classification, Labeling and Packaging of Substances and Mixtures

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Not liable for contents. Provided as-is.

MDD/MDR IVD/IVDR PPE Cosmetics Other
RoHS Mfg Mfg If electric, Mfg
WEEE EU Importer EU Importer If electric, Mfg
REACH EU Importer EU Importer EU Importer EU Importer
RED Mfg Mfg If radio, Mfg (bluetooth)
Battery Mfg Mfg If battery, Mfg
Packaging Mfg Mfg Mfg Mfg Mfg
Machinery Mfg, as applicable Mfg, as applicable Mfg
EMC Included Included If electric, Mfg
Low Voltage Included Included If electric, Mfg
General Product Safety Mfg
General Data Protection Mfg/User Mfg/User Mfg/User Mfg/User Mfg/User

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Not liable for contents. Provided as-is.

International Quality Associates
International Quality Associates

We can assist with

Specific to medical devices and in-vitro diagnostic devices, we can assist with

  • TCF – Building technical files, and STEDs (based on IMDRF) for submissions

  • Labeling: Verification of device labels, instructions for use, and Translations

  • Device risk classification

  • EU Declaration of Conformity

  • Certification

    • Selection of Conformity Assessment Procedures and Approvals Process
    • Self Certification if applicable
    • Use of Notified Body
  • Market surveillance by EU Competent Authorities

  • MDD and IVD transition and timeline

    • Transition from MDD to MDR (medical devices)
    • Transition from IVD to IVDR (in vitro diagnostic devices)
  • Labeling

    • UDI, including SRN (Single Registration Number)
    • European Authorized Representative (EC REP)
  • Documentation

    • STEDs (Summary of Technical Documentation, based on IMDRF guidance)
    • Clinical Evaluation (literature route)
  • Market registration for low risk devices

  • Roles and responsibilities of  economic operators, including importers and distributors

  • Own brand or private labeling versus “Made for By”

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