Medical devices white papers

Throughout the year, we are going to be producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.

Sign up for forthcoming white papers

All our white papers will help you perform better, manage risk so that you make excellence a habit in your organization.

Forthcoming white papers within the medical devices series will cover subject areas as follows:

  • Generating clinical evaluation reports: A guide to effectively analysing medical device safety and performance
  • The digital patient
  • What medical device manufactures need to know about FDA’s Unique Device Identification Final Rule
  • Post-market surveillance
  • Usability engineering 

To find out more and when these white papers are published please register your interest and we will contact you as soon as they are published.

Medical devices standards

To help sift through the minefield of regulations, BSI British Standards can help with best practice guidelines, standards, supporting documentation and seminars.  Here are some bestselling standards within your industry: 

  • BS EN 60601-1:2006 A1:2013 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • BS EN ISO 13485:2012 Medical devices. Quality management systems. Requirements for regulatory purposes
  • BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
  • BS EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems
  • BS EN ISO 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labeling and information to be supplied. General requirements

Activities of the notified body

As a Notified Body under the Medical Devices Directives, BSI has one of the broadest scopes of any Notified Body.

  • The Medical Devices Directive (MDD) - all products
  • The Active Implantable Medical Devices Directive (AIMDD) - all products
  • The In Vitro Diagnostics Directive (IVDD)

This means whatever type of device a manufacturer wishes to market in Europe, where CE marking is now a legal requirement, BSI has the technical expertise to assist and provide appropriate conformity assessment services.