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 |
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