CE Mark

ce_markDAC Audit Services is pleased to announce an expansion of its audit services.

We can now provide for CE marking thru our notified body partner.  Please read below some preliminary information regarding this.

DAC Audit Services announces the introduction of a unique and proprietary program in the USA - the Elite Program for the medical device industry. Medical Device manufacturers no longer have to be “in the dark” regarding their pursuit of ISO Registration and CE Markings. The Elite Program keeps these clients "in the loop" by their being continuously updated as to their ISO vs CE status. This is achieved through their personally assigned Elite Specialist from the inception of ISO registration to final CE marking.  The end result of this program is a more satisfied client who has experienced minimal frustrations.
 
Our notified body partner serving the EU offers decades of experience to US and international companies. They are one of the oldest and most established in the European Union, with the largest scope of accreditation.  They have owned and operated an accredited test and calibration laboratory for the EU for more than 50 years.
 
Medical device companies have traditionally faced numerous challenges in their pursuit of ISO 13485.  The Elite Program removes these difficulties by providing extensive positive reinforcement and exceptional supportive guidance via their Elite Contact Specialist at DAC Audit Services.
 
The Elite Program guarantees these clients with more personalized interactions with their auditors, engineers, and administrative staffing.  They are more informed and less stressed by the demands of ISO 13485 Registration and CE marking.
 
Together, DAC Audit Services and its notified body partner provide a more simpler process to address the needs of Medical Device manufacturers in the US and abroad.

Looking to enter the EU market?

Is your company looking to expand and sell your product in the European Union (EU)?

If so, you will need to conform to the EU regulatory requirements (CE Mark) before you can start selling any products in the EU. The CE mark is placed on a product as the manufacturer’s visual identifier.  It indicates that the product meets the requirements of relevant European Directives. CE Marking is mandatory for a wide range of products sold within or exported to the European market.

Complying with CE marking is a critical issue when looking to launch your product on the global marketplace. Understanding the myriad of regulations that affect your product in your target market is key to your success.

Our assessment process begins with understanding where your product(s) is to be marketed, who will use the product, and its intended use. Your response to these questions will help us to identify the regulatory barriers, the Directives, Standards, and your conformity assessment route options. This will help us develop a rationalized Compliance plan for your product in the European Union.

The difference between FDA / CE marking.

Many companies in the United States assume the CE marking is equivalent to FDA approval or clearance, which is not accurate.

FDA is a USA approval, CE marking is the European Union approval.

A CE marking:

  • is not equivalent to FDA approval /clearance
  • confirms the safety of a product
  • does not confirm effectiveness of a product

A CE marking affixed to a product is a declaration by the person responsible that:
  1. the product conforms to all applicable Community provisions
  2. the appropriate conformity assessment procedures have been complete

CE marking has 4 classes for products - Class I, IIa, IIb, III and IV.

There is an extensive set of rules in Annex IX of the MDD to enable a company to determine the classification of their medical product. Companies need to determine their own classification, but a notified body has the authority to challenge and/or change this classification. 

History of CE

Since 1985, the European Union has provided harmonized technical standards for products sold in the EU. The aim is to protect consumers while making sales to member states easier. These harmonized health and safety requirements are written down in a series of directives, known as New and Global Approach directives. A product that meets the requirements of the directives is to be marked with CE marking. A product can be subject to one or more directives. Products under the scope of one or more of these directives that do not meet the requirements, are not allowed to bear CE marking and do not have access to the Common European Market. These directives apply to all products that are to be put into use in the common market, whether they are manufactured inside the EU or imported from outside the EU. The EU consists of the member states of the EU, and the members of the European Free Trade Zone.

stairsAdvancing towards CE marking.
Steps which you should follow.

The actions required to become compliant with the Directives vary according to which Directive(s) apply to your product(s) and type of classification of the equipment as defined by the Directive(s). However, there are some general steps you should follow:

  • Determine which, if any, EU Directives apply to your product(s).
  • Determine the extent to which your product already complies with the essential requirements of the Directives.
  • Choose conformity assessment routes. Depending on the nature of the equipment or product, you may be able to implement and declare compliance, and affix the CE mark without assistance or service from an external company.
  • In some cases, the Directives require and mandate the use of a Notified Body.

Types of Directives:
What products do the directives cover?

The Directives apply to a wide range of products.  The most notable products likely to need CE marking are:
  • Pressure equipment
  • Machinery of almost any description
  • Electrical and electronic equipment
  • Medical devices and equipment
  • Personal protective equipment
  • Equipment for use in potentially explosive environments

The requirements of the Directive are to ensure that manufacturers have identified and addressed all aspects of design and manufacturing that could impact safety and the safe operation of the equipment.

startingStarting the Process
Procedure to be undertaken.

Before a manufacturer or importer is allowed to place CE marking on his product, there are a few steps to be undertaken. Some of the most essential steps are:

  • Risk Assessment to verify that the product is safe to use and meets all requirements of the applicable directives.
  • Drawing up a User’s Manual with instructions for safe usage and warnings for dangers (when applicable).
  • Drawing up a Technical File, which content shows that the product meets all applicable requirements.

For the more dangerous products, intervention of a Notified Body, a Conformity Assessment body, is required. There are a number of conformity assessment modules available to the manufacturer or importer to choose from. Some modules are based on testing of every single product; others are based on EC-type approval, sometimes in combination with a quality assurance system (e.g. ISO 9001) evaluation.

The Notified Body will assess the Technical File and evaluate the actions and measures taken by the manufacturer or importer. In some cases, depending on the Assessment Module chosen, a physical inspection and test of the product will take place. When the Technical File, the product and the procedure are approved, the Notified Body will issue an EC Type Approval or EC Certificate of Compliance.

Contact us at 978-386-2516 or just click here to request more information. phone_laptop