CE CERTIFICATION IN AHMEDABAD, GUJARAT, INDIA.

The letters “CE” is the abbreviation of French phrase “Conformité Européene” which literally means “European Conformity”. The term originally used was “EC Mark” and it was officially replaced by “CE Marking” in the Directive 93/68/EEC in 1993. “CE Marking” is now used in all EU official documents.

With the CE marking on a product the manufacturer ensures that the product conforms to the essential requirements of the applicable EC directives.

*Product Directives contains the “essential requirements” and/or “performance levels” and “Harmonized Standards” to which the products must conform. Harmonized Standards are the technical specifications (European Standards or Harmonization Documents) which are established by several European standards agencies (CEN, CENELEC, etc). CEN stands for European Committee for Standardization.CENELEC stands for European Committee for Electrotechnical Standardization.

1. CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.
2. CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.
3. CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries), and
4. CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.

Does my product need CE Marking?

CE Marking is most probably required if you export to the 27 European Union (EU) and 3 European Free Trade Association (EFTA) member states the following 20 groups of products –

1. Appliances Burning Gaseous Fuels (AppliGas)
2. Cableway Installations to Carry Persons
3. Low Voltage Electrical Equipment
4. Construction Products
5. Equipment and Protective Systems for Used in Potentially Explosive Atmospheres (Atex)
6. Hot Water Boilers
7. Explosives for Civil Uses
8. Lift
9. Machinery
10. Measuring Instruments
11. Medical Devices
12. Active Implantable Medical Devices: means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity
13. In Vitro Diagnostic Medical Devices: means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body
14. Non-automatic Weighing Instruments
15. Radio Equipment & Telecommunications Terminal Equipment (R&TTE): means a product, or relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radio communication.
16. Personal Protective Equipment (PPE)
17. Simple Pressure Vessels
18. Pressure Equipment
19. Recreational Craft
20. Toys
21. Face Mask / N95 Mask / Medical Mask
22. PPE Kit

Below given is related CE to Medical Device Certification

Medical device certification CE Marking – MDD Directive

Medical Devices classified under the MDD must be registered with a Competent Authority before they can be sold in the EU bearing the Requisite CE Mark. As a Notified Body under the Competent Authority of the UK, UL’s scope under the MDD includes class I sterile, class I measuring, class IIa, class IIb and I class III Active Medical Devices.

Medical device certification CE Marking – IVD Directive

UL has experienced staff with over 100 years of combined experience in In Vitro Diagnostic Devices. UL has full competency and accreditation in IVD List A, List B and self-test devices. Our scope of accreditation aligns to meet the diverse and ever changing needs of the IVD industry to include most self-test devices including devices for urine analysis, endocrinology, general biochemistry and chemistry, general immunology, and diabetes diagnosis and management.