Regulatory/CE Marking

Regulatory/CE Marking, National Product Approvals And Pharma Registrations

The majority of Medical Devices companies now understand the importance of conforming to CE requirements for the European Union. However now outside of the EU a number of other countries are adopting the EU Guidelines for Product Regulatory Approvals. What does this mean for the manufacturer?

Very simply this means an extra strain is put on an already stretched Regulatory Department of a Start Up or SME. Pan Globus is able to assist your in-house Regulatory Affairs Department by providing an outsourced asset that will enable you to penetrate International markets without taking your resources away from your all important Domestic Market. The end result is more markets effectively covered, greater revenue and faster time to market for new products.

A few examples of the CE Regulatory Requirements of the MDD

"CE marking is an indication that a product complies with the essential requirements of applicable directives and that the product has been subject to conformity assessment procedures as provided in the directives. It allows the product to be freely marketed within the EEA. The marking applies only to products regulated by European health, safety and environmental protection"

Before application of the mandatory CE marking, certain products may need to comply with more than one directive. If a product is subject to several directives providing for CE marking, the marking indicates that the product conforms to the provisions of all these directives. Following are some directives that may affect manufacturers of medical devices:

Medical Device Directive (MDD): 93/42/EEC.

This directive concerns many medical products defined, in part, as "any instrument... or other article... to be used on human beings for the purpose of: and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means..."

Significance for Manufacturers and Exporters

The clearest benefit in CE marking is that it results in only one set of laws and regulations to comply with in designing and manufacturing for the entire expanded European marketplace. The multiple and conflicting national restrictions on regulated products are eliminated.

Specific MDD procedures require medical device manufacturers to adhere to specific provisions for conformity assessment. These procedures are based on risk assessment categories established by the MDD: Class I, Class IIa, Class IIb, and Class III.

When must a Notified Body be used?

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 by an 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.

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