EU Referendum Result
After Britain voted to leave the EU, BSI will continue to operate as an EU Notified Body.
Read our full statement to understand more about BSI's position.
How BSI can support your medical device business
We understand the specific challenges medical device manufacturers face and the importance of bringing innovative yet safe products to global markets. Ensuring the predictability and transparency of regulatory product clearance is key to maintaining a competitive edge.
Our commitment to excellence
Manufacturers tell us they need to work with a highly competent, customer focused Notified Body that understands the specifics of their environment and the importance of complete confidentiality around patent pending new technology.
Our services are designed to align with the steps individual clients need to take to understand what is best practice, how to achieve it and ensure that it remains an ongoing habit.
We provide rigorous quality management reviews and product certifications for medical device manufacturers around the world, and we can do it for you too.
The new revision of MEDDEV 2.7.1 Revision 4: Key changes and clarifications
Revision 4 of the MEDDEV guidance document 2.7.1 - Clinical Evaluation: A guide for manufacturers and notified bodies under Directive 93/42/EEC and 90/385/EEC - was released by the European Commission on 1st July 2016.
This document provides information to manufacturers on conducting a clinical evaluation, including demonstration of scientific validity of your data and conclusions.
Download your copy now
Supporting you with the latest regulatory changes
To support you through your product development journey and to keep you up to date with the latest regulatory changes, we have dedicated webpages that focus on the latest regulatory changes such as understanding the process of unannounced audits and learning more about the practicalities of the revision to ISO 13485 QMS.
Below you will find links where you can learn more about these changes.
Our mission is to ensure patient safety while supporting timely access to global medical device technology. We strive to set the global standard in thorough, responsive, predictable conformity assessments, evaluations, and certifications.
The BSI Medical Device Mission
Want to know more about the Notified Body?
Download the BSI Guide to Notified Bodies to find out the answer to these and many other questions:
- What is CE marking?
- What is the role of the Competent Authority?
- What is the role of the Notified Body?
Featured White paper
Planning for implementation of the European Union Medical Devices Regulations – Are you prepared?
This paper focuses on the practical aspects of implementation and highlights some of the major changes. It discusses decisions that need to be made by affected organizations and includes questions to ask about your organization’s preparedness in order to comply with the new requirements. This information is intended to assist in developing an implementation plan.
Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, contact our expert team who will guide you through the process.