CE Marking and European Regulations

Gain market access with a CE mark

CE marking certification medical devices BSICE Marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives. The Directives outline the safety and performance requirements for medical devices in the European Union (EU). The CE mark is a legal requirement to place a device on the market in the EU.

As a Notified Body under the Medical Device Directives, BSI has the technical expertise and experience to provide CE Marking services.

How do I obtain CE marking?

CE marking is the manufacturer's declaration that the medical device meets the appropriate regulatory requirements. To understand which requirements you need to meet, you must classify the device and identify the appropriate conformity assessment route for your product. This dictates the required activities to demonstrate conformity. We will review the route you chose to confirm its suitability, and work with you to execute the most efficient review process for the route selected. Our trusted review processess allow you to build  reliability and confidence into your CE marking project planning. 

Key resources to help you gain CE certification

CE-Excellence: technical documentation review services

CE-Excellence: technical documentation reviewsBSI has a strong commitment to providing the most experienced and efficient routes to global markets. That is why we offer you our trusted technical documentation review service, CE-Excellence. We understand the challenges of achieving market access efficiently and safely, meeting commercial goals and regulatory requirements. Our services have been developed to support manufacturers seeking timely market access without compromise. They combine efficiency with the integrity, independence, predictability and thoroughness that you have come to expect from BSI.

We can provide the following CE marking services:

CE-Standard

CE-StandardThe BSI CE-Standard review service allows you to work closely with your assigned BSI Product Expert on your product certification. These reviews are conducted remotely, with communication between you and your BSI Product Expert via phone and email, as required.

CE-Dedicated

CE-Dedicated

The BSI CE-Dedicated review service allows you to schedule your technical documentation review with a dedicated BSI Product Expert. The review is conducted remotely via teleconferencing, allowing you to engage with your dedicated BSI Product Expert and provide immediate responses to their questions. This allows predictability in planning for the review, and can improve the efficiency of the review process.

CE-Onsite

CE-OnsiteThe CE-Onsite review service is conducted at your premises; a BSI Product Expert visits the facility for a period of time. CE-Onsite reviews allow for dynamic communications and opportunities for immediate responses to questions raised by the reviewer. Planning a CE-Onsite review in advance provides you with more predictability and the reassurance of knowing when your BSI Product Expert will be at your premises.

 

Note: Our services do not guarantee a CE Marking certificate will be issued within a certain amount of working days, but are based on completing the review process with either a positive or negative recommendation. CE-Dedicated and CE-Onsite is not available for devices utilising animal tissue, blood derivatives or medicinal substances.

Why choose BSI 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 using our wealth of expertise.

Benefits of CE marking

  • Understand regulations of AIMDD, MDD and IVDD plus additional directives
  • Move past administrative setbacks without delaying approval
  • Define unclear requirements on the quantity and quality of clinical data required
  • Resolve the unclear regulatory status of a (borderline) product
  • Prepare for any revised legislation during reviews

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