CE Marking

November 16, 2015

Who is a Competent Authority and a Notified Body?

A Competent Authority is the body, which has the authority to act on behalf of the government of a member state to ensure that the requirements of the Medical Devices CE Marking directives are carried out in that particular member state. The European Union (EU) comprises 28 member states. Each member state is party to the founding treaties of the union and thereby subject to the privileges and obligations of membership. Notified Body is a […]
January 10, 2014

CE Marking

Is CE MARKING valid ACROSS the world market? No. CE marking is required for the European market only. It is valid in all 32 countries of the European Economic Area. But its sure without any doubt, CE marking make it easier to obtain access to other markets, such as Australia, India, Middle East Countries, Turkey.
November 9, 2013

Drug Master File

The information contained in the Drug Master File (DMF) may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application or amendments and supplements to any of these. The US DMF contains factual and complete information on a drug product chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product.
February 9, 2013

Combinations of Medical Devices with CE Marking

According to CE Marking MDD article 9.1 and the “Essential Requirements” in annex 1 of the Directive 93/42/EEC, when a medical device is intended for use in combination with another medical device or other equipment, the combination, including the connection system, must be safe, and must not impair the specified performance of the individual devices. To ensure safety when putting into service and during use, article 13.6.c and annex 1 of CE Marking Directive 93/42/EEC […]