CE marking: speed to market for medical devices

Reach global markets quicker with our speed to market programmes

CE marking: speed to market medical devices BSIBSI has a strong commitment to providing the most experienced and efficient routes in helping your product reach global markets. We offer a variety of product reviews to help ensure that, regardless of your specific needs or product requirements, you will be better positioned to achieve CE marking within your timeline and within your budget.

Fast and experienced routes into global markets

In the race to get new medical devices to market, speed is a critical component. We have a strong commitment to providing the most experienced and fastest routes to European markets. Our programmes have been developed especially for Class III medical devices needing CE marking Design Dossier Reviews. They combine speed to market with the integrity, independence, predictability and thoroughness that you have come to expect from BSI.

Our CE marking speed to market programmes

Our clients enjoy working with us because we understand the challenges that medical device manufacturers face in getting compliant products on the market quickly. We are continually developing speed to market programmes to meet the demands of the medical device industry.

Please Note: Our programmes 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. FastTrack is not available for devices utilising animal tissue, blood derivatives or medicinal substances.

We can provide the following CE marking speed to market programmes:

CE-Onsite FastTrack

BSI CE-Onsite FastTrack Review Service is conducted at the customer’s premises, in which BSI product experts visit the facility for a dedicated period of time. This premium service works toward a CE marking target of 45 working days from submission. Onsite reviews usually allow for a much faster timeline with dynamic communications and opportunities for immediate response to questions. Real time for real results.

CE-Dedicated FastTrack

BSI CE-Dedicated FastTrack Programme is designed for high risk medical devices requiring design dossier reviews. We provide you with the same high quality reviews just at an accelerated rate, usually within 45 working days or less. CE-Dedicated is conducted via teleconferencing, as a result it does not require product experts to travel to the customer’s site. This means scheduling times can be more flexible and adjusted if needed.

CE-45 FastTrack

We make getting your product to global markets as important to us as it is to you. BSI knows every day can have an impact on the bottom line, so we created the CE-45 FastTrack Programme. The CE-45 is an expedited Design Dossier service where most reviews are completed within 45 working days from submission. Our goal is to assist you in getting your products to market faster, realizing a faster return on your investment.

Please note

Programmes do not guarantee a CE marking certificate in a certain amount of working days but commits to completing the review process with either a positive or negative recommendation.

Programmes exclude reviews outside BSI’s control (e.g., products containing medicines, animal or blood derivatives).

Note: working days indicates days that BSI’s experts spend conducting the reviews, and does not include time when clients are answering questions, or when reviews are with a Competent Authority.

As a Notified Body, BSI provides confidence, allowing you to manage product launch risk

  • Experience and expertise - You can be rest assured by increased patient safety, thereby reducing your corporate risk.
  • Tailored Service - BSI offers a premium customized service, giving you a greater level of flexibility as well as predictability.
  • Market Access - Our speed-to-market service means your product reviews won't slow down your launch plans, helping you to stay ahead of the competition.