About KwalityCert

Kwalitycert was founded with a mission to help organizations to transform their businesses and empower business professionals using ISO as a tool. We always have relied on our global experience, employees, partners and associates in delivering concrete pragmatic solutions to clients that are holistic and sustainable.

Follow Us

How to get CE Mark certification?

CE certification

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
  • Atex – Exproof
  • 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  

    Leave a Reply

    Your email address will not be published. Required fields are marked*