If you are a manufacturer of medical devices and want CE marking on your product, in addition to other requirements you must need to appoint an Authorised Representative in European Market. For you we have exclusive agreement with an Authorized Representative, we shall be glad to offer services of the Authorized Representative.
Please remember that in order to sell medical devices and IVDs in the European Union, you must first CE Mark your product. The CE Mark is not a quality mark, nor is it intended for consumers. CE marking indicates to EU regulators that your device meets all applicable requirements of the appropriate EU Directive, such as the Medical Devices Directive (MDD), In Vitro Diagnostic Device Directive (IVDD) or Active Implantable Medical Device Directive (AIMD), as they apply to your product.
CE MARKING FOR PERSONAL PROTECTIVE EQUIPMENT (PPE)
(Gloves, Guards, Protectors protective clothing, safety shoes etc)
If you are manufacturer of PPE like Gloves, Guards, Protectors, Protective Clothing, High Visibility Clothing, Safety Shoes and many other Personal Protective Equipment then your products must meet applicable requirements of Council Directive 89/686/EEC and carry CE mark before being placed these products to the EU Market. The compliance of the most of the products is demonstrated on basis of compliance to the relevant harmonized standards. For you we have exclusive agreement with renowned notified body / accredited laboratory which tests and certifies your products against the relevant standards.
