CE marking approval - European Market Access

CE Marking
As a Notified Body, we can help you gain access into the European market by ensuring your product meets all CE marking requirements.

CE marking allows you to legally market and distribute your product within the European Market, and declares that your product complies with all applicable European Directives and Regulations. 

As a Notified Body for many EU Directives and Regulations, we will work in partnership with you, helping you to understand and comply to the essential requirements, and enabling you to confidently and legally affix CE marking to your products.

We provide open and honest assessments, technical assistance, key account management and accurate reporting to help you bring your products to market successfully.

How BSI can simplify your path to CE compliance

With a vast range of product certification experience, BSI offers a comprehensive and personally tailored service to take your product through the CE marking process quickly and efficiently.

Our team of testing and certification experts assigned to work with you, will be willing and able to advise you every step of the way.

Our aim is to provide you with a high quality, fast, reliable and stress-free service that un-complicates the process and enables you to meet your deadlines

EU Directives

With Certifying Body status for many of the European Directives, BSI can offer one of the most comprehensive CE Marking (CE Mark) certification services in the world and has a team of experts who understand precisely what each Directive requires for each product – to make your life easier.

BSI is currently a Certifying Body for the following European Directives.

What are the benefits of CE Marking?

The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. 

Often customers will look for CE marking on a product as an indication of conformance to certain minimum standards, and therefore a minimum level of quality that other products may lack

For consumers:

CE marking itself is not about quality, nor is it intended to convey any meaning to specifiers, purchasers or end users who are, after all, reasonably entitled to assume that what they buy from a reputable source is legal.

CE marking and European Directives

The letters CE on a product are intended for regulatory surveillance authorities.  They represent the manufacturer's claim that the requirements of all relevant European Directives have been satisfied. Many products are covered by these Directives and for some, such as toys, it is a legal requirement to mark the product accordingly.

CE marking on a product, its packaging or accompanying information indicates that the minimum levels of quality and health & safety have been met. CE marking provides for the product to move freely throughout the European Single Market.

CE marking may simply involve testing carried out by the manufacturer or it may involve intervention of an independent third party, depending on the product and the Directive concerned. Purchasers may need to check the CE marking accompanying information to ascertain that the product is appropriate for their needs.

In summary

In summary then, the CE marking indicates that the manufacturer has met the minimum legal requirements for their products in regard to health and safety under European Directives. CE marking is not, therefore, intended to be a quality mark.

Why choose BSI Australia for your CE marking approval?

Expansion into global markets like Europe represents a profitable future for medical device manufacturers, but this transition also requires an in-depth understanding of complicated regulatory demands and unique market challenges. With the goal of bringing your product to market in the most efficient manner possible, we can help you overcome every hurdle along the way. Our wealth of expertise across the medical device space allows you to:

  • Understand the regulations of three different council directives (AIMDD, MDD and IVDD) as well as the six amending commission directives, and other additional directives
  • Move past unforeseen administrative setbacks without delaying market approval
  • Define unclear requirements on the quantity and quality of clinical data required
  • Resolve the unclear regulatory status of a (borderline) product
  • Prepare for and adjust to any new and/or revised legislation that will go into effect during your review