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How To Get CE Mark Certification?

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WHAT IS CE CERTIFICATE?

CE (“European Conformity”) Marking is a certification mark indicates that a product fulfils the requirements of relevant European product directives, safety health & environmental protection standards. The CE mark certified products can be affixed with CE Mark on the product or on the packaging.

WHY CE CERTIFICATION?

CE Marking on a product is mandatory to prove it meets the regulatory & safety requirements of the relevant Directive before it is placed in the market.

BENEFITS OF CE CERTIFICATION

  • Barrier free to enter European Market & also considered as trade passport
  • It builds confidence in the customer for to buy the products
  • Products are said to be safe and reliable

 

WHAT PRODUCTS NEED CE MARKING?

  • Medical Devices & Invitro Diagnostics
  • Active implantable medical devices
  • Appliances burning gaseous fuels
  • Lifts
  • Construction products
  • Pressure Equipment
  • Hot water Boilers
  • Simple pressure vessels
  • Electrical Equipment
  • Electromagnetic compatibility
  • Personal protective equipment
  • Noise Emission in the environment
  • Household refrigerators & freezers
  • Low Voltage & machinery
  • Measuring & Non-automatic weighing instruments
  • Radio equipment & telecommunications terminal equipment
  • Apex – Reproof
  • Safety of Toys
  • Restriction of hazardous substances in electrical & electronic equipment

CE Marking does not apply to items such as:

Limited Chemicals, Pharmaceuticals, cosmetics & Foodstuffs

GAINING CE CONFORMITY:

A full description of the conformity Assessment procedures and their associated requirements for a documented Quality management system. Details of the manufacturers tasks under each conformity module and the basic requirements for manufacturers of industrial products.

LIST OF DIRECTIVES – EU CE MARKING

1.         Machinery Directive – 2006/42/EC

2.         Low Voltage Directive – 2014/35/EU

3.         EMC Directive – 2014/30/EU

4.         Medical Devices Directive – 93/42/EEC

5.         Personal Protective Equipment Directive – 89/686/EEC (as of 21 April 2018 replaced by the  Personal Protective Equipment Regulation (Regulation (EU) 2016/425)

6.         Construction Products Regulation –  Regulation (EU) No 305/2011

7.         Pressure Equipment Directive – 2014/68/EU

8.         REACH – Regulation (EC) No 1907/2006

9.         RoHS – Restriction of Hazardous Substances – Directive – 2011/65/EU

10.       Waste Electrical and Electronic

Equipment Directive – 2012/19/EU

11.       ATEX Directive – 2014/34/EU

12.       Toy Directive – 2009/48/EU

13.       Radio Equipment Directive – 2014/53/EU

14.       Recreational Craft Directive – 2013/53/EU

15.       Active Implantable Medical Devices Directive – 90/385/EEC

16.       Explosive for Civil Use Directive – 93/15/EEC

17.       Noise Emission in the Environment Directive – 2000/14/EC

18.       Gas Appliances Directive – 2009/142/EC

19.       Lifts Directive – 2014/33/EU

20.       Pyrotechnic Directive – 2007/23/EC

21.       Measuring Instruments Directive –

2004/22/EC

 

 

STEPS INVOLVED IN CE MARK CERTIFICATION PROCESS FOR MEDICAL DEVICES

Stages Activity Responsibility Duration
Step 01 Appoint Medical Device Regulatory Consultant Client 7 Days
Step 02 Identify product standards and International standards Consultant + Client
Step 03 Determination of Intended use& Classification of MD & IVD Client 20 Days
Step 04 Production, Process, Sterilization, Environment requirements Consultant
Step 05 Risk Analysis Consultant + Client
Step 06 Identification of HARMONIZD Standards and Testing Laboratories Consultant + Client
Step 07 Collection of data related to device functionality and Shelf life Client
Step 08 Biocompatibility and sterilization related documents Client
Step 09 Clinical Evaluation Consultant
Step 10 Vigilance and Post market documents Consultant
Step 11 Technical File preparation Consultant
Step 12 Submission of Technical file to Notified Body Consultant + Client 45 Days
Step 13 Review of Technical file Notified Body 15 Days
Step 14 Supplementary Document Submission if requested by Notified Body Consultant + Client 60 Days
Step 15 Onsite Audit (ISO 13485 + MDD) NB + Client 02 – 04 Days
Step 16 Closure of NC’s Consultant + Client 02 – 04 Days
Step 17 Affix CE Mark Client

 

CE Mark 1

CE Mark Certification in Jordan

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However, it’s important to understand that CE marking is a conformity marking indicating compliance with European Union (EU) product safety directives and regulations.

Jordan is not part of the European Economic Area (EEA), and CE marking is primarily applicable to products placed on the market within the EEA, including EU member states as well as Iceland, Liechtenstein, and Norway.

If you intend to export products to the EU or countries that recognize CE marking requirements, you need to ensure that your products meet the applicable EU directives and regulations and undergo the necessary conformity assessment procedures.

Qualitcert or any other certification body may be able to assist you with conformity assessment services and guidance on meeting CE marking requirements for your products. However, it’s important to note that CE marking may not be directly applicable to products sold in Jordan.

For products intended for the Jordanian market, you should research and understand the regulatory requirements and standards applicable to your products in Jordan. The Jordan Standards and Metrology Organization (JSMO) is the national standards body in Jordan responsible for developing and implementing standards in various fields. They may provide guidance on product certification and compliance requirements within the country.

 

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CE Mark Certification in Lebanon

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However, it’s important to note that CE marking is a conformity marking that indicates compliance with European Union (EU) product safety directives and regulations.

Lebanon is not part of the European Economic Area (EEA), and CE marking is primarily applicable to products placed on the market within the EEA, including EU member states as well as Iceland, Liechtenstein, and Norway.

If you intend to export products to the EU or countries that recognize CE marking requirements, you need to ensure that your products meet the applicable EU directives and regulations and undergo the necessary conformity assessment procedures.

Qualitcert or any other certification body may be able to assist you with conformity assessment services and guidance on meeting CE marking requirements for your products. However, it’s important to understand that CE marking may not be directly applicable to products sold in Lebanon.

For products intended for the Lebanese market, you should research and understand the regulatory requirements and standards applicable to your products in Lebanon. The Lebanese Standards Institution (LIBNOR) is the national standards body in Lebanon responsible for developing and implementing standards in various fields. They may provide guidance on product certification and compliance requirements within the country.

 

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CE Mark certification in Australia

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As of my last knowledge update in January 2022, I don’t have specific information about “qualitcert” or its services, and it’s possible that the company may have gained recognition or changed its operations since then. Therefore, for the most accurate and up-to-date information, you should directly contact qualitcert or visit their official website.

If “qualitcert” is indeed a certification body offering CE Mark certification services in Australia, you may follow general steps for CE Marking:

  1. Contact Qualitcert: Reach out to qualitcert directly through their official channels. This could include their website, contact forms, or direct communication via email or phone.
  2. Inquiry and Discussion: Discuss your product and regulatory requirements with qualitcert. Provide details about your product, its intended use, and any existing certifications or testing.
  3. Assessment and Proposal: Qualitcert will likely conduct an assessment of your product against the relevant EU directives and standards. They may provide a proposal outlining the steps, costs, and timelines for the certification process.
  4. Product Testing: Depending on the type of product, testing may be required to ensure compliance with applicable EU standards. Qualitcert or a partner testing laboratory may perform or oversee these tests.
  5. Documentation Review: Prepare and submit necessary documentation, including technical files, risk assessments, and other relevant information. Qualitcert will review these documents to ensure they align with CE Marking requirements.
  6. On-Site Audit (if required): In some cases, an on-site audit may be necessary to verify the manufacturing processes and quality control measures. Qualitcert may conduct this audit to ensure ongoing compliance.
  7. CE Marking Approval: Upon successful completion of the assessment, testing, and documentation review, qualitcert will issue the CE Mark certification. You can then affix the CE Mark on your product, indicating compliance with relevant EU regulations.

It’s crucial to ensure that qualitcert is recognized and accredited by relevant bodies for providing CE Mark certification services. In the context of CE Marking, accreditation bodies often play a role in ensuring the competence and impartiality of certification bodies.

Always verify the current status and accreditation of any certification body you choose to work with. Additionally, you may want to seek feedback from other companies that have used qualitcert’s services or explore alternative certification bodies for comparison.