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AQA International, Meyer Offer European Market Compliance Solutions

Trade & Development - Legal

COLUMBIA, SC – AQA International is proud to announce fully accredited ISO 13485 & CE Mark via its relationship with Meyer Ltd. Meyer is a European Community Notified Body (CE 1984) based in Turkey and has been a solution provider for AQA International since 2000.

Manufacturers who want to sell products in different countries must meet the various rules in each market and prove that the product conforms to the technical requirements of those markets. This usually means that the products have to be modified and re-tested to meet different approval procedures for each country. Such procedures are often both complex and time-consuming. They increase the cost of products, delay their introduction onto the market and generally restrain the free movement of goods.

The European Union has been actively working towards the removal of such technical barriers to trade. At the same time, however, it has been ensuring the necessary protection of health, safety and the environment within the EU and with its trading partners. The CE Mark on a product indicates to all authorities that the product is in compliance with the essential health and safety requirements of all directives that apply to the product. As a consequence, such products can be placed on the market in any country within the European Union or wider European Economic Area.

All products covered by new approach directives must bear the CE marking which indicates conformity to the essential requirements. By affixing a CE marking to a product, the manufacturer confirms that all required conformity assessment procedures have been followed.  

The CE marking is a European proof of conformity and is also known as "Trade Passport to Europe," which allows manufacturers and exporters to circulate products freely within the EU member states. For most products, depending upon the product and the nature of the risks it presents, there are several routes to evaluation of conformity and the ultimate CE marking of a product. An assessment must be made and documented in the manufacturer's TCF before CE marking is affixed and before the product is made available or put into service.

Options for medical devices with minimal risk include self-certification where the manufacturer prepares a declaration of conformity and affixes the CE marking to the product. Other products with greater risks call for voluntary certification by a notified body. Other medical devices may not be self-certified, but must be subjected to the EC type examination. This examination involves the inspection of a representative example by or on behalf of an external inspection organization or notified body within the EEA. Devices with even greater risks require tests, audits or additional certificates from a notified body before CE marking can be affixed.

Accredited ISO 13485 quality management systems are critical to medical device supply chain acceptance and full compliance with CE marking for more advanced products. AQA International is proud to offer the following services:

  • Provide information on regulations and certification procedures
  • Supply an expert opinion concerning classification of devices
  • Device Classification Confirmation Services: It is imperative for the manufacturer of a product/device/apparatus/ piece of equipment to be placed on the European Market to firstly classify their products under EU 2007 57 EC MDD Directive, whether it is a medical device, an in-vitro diagnostic medical device, an active implantable medical device, a low voltage product with or without electromagnetically compatibility, a radio and telecommunication apparatus, machinery, cosmetics, personal protective equipment, pressure equipment, a construction product, a toy or any combination of such – it must be classified before it is to be regulated! MEYER does this for the manufacturers
  • Preliminary Assessment Services: AQA can provide an impartial third-party assessment of your quality management system and technical file(s) against the requirements of the Medical Devices Directive
  • Own Brand Labeling Services: AQA  offers full Own Brand Labeling Services (OBL) to "Legal Manufacturers" that choose to apply their own name to products that have been designed and manufactured by an Original Equipment Manufacturer (OEM).
  • Training
  • Issue the certificates required for CE marking
  • Carry out EC examinations of design files
  • Carry out EC type examinations: AQA has the technical capability and knowledge of changing requirements to test when, where, and how you need it, to get your device to market faster than ever before
  • Carry out EC verifications: AQA will either test every unit or every batch of product to ensure that they are meeting the requirements before the manufacturer can place them onto the market
  • Perform conformity tests to harmonized European standards or other standards
  • Perform quality system audits in accordance with the annexes of the Directives
  • Assess clinical, biological or scientific data, in consultation with hospital experts when required

Audits will be performed by fully qualified U.S.-based lead auditors.

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