The regulatory requirements for European market access
The requirements for medical devices are changing. Since the 1990s, the core legal framework for medical devices in the EU has consisted of three directives:
- Directive 90/385/EEC regarding active implantable medical devices (AIMD)
- Directive 93/42/EEC regarding medical devices (MDD)
- Directive 98/79/EC regarding in vitro diagnostic medical devices (IVDD)
These Directives are being replaced by the new Medical Devices Regulation and IVD Regulation, published on May 5th 2017. Until notified bodies are designated to certify against the new Regulations, all medical devices must fulfil the essential requirements set out in the above mentioned Directives. Where available, relevant standards may be used to demonstrate compliance with the essential requirements defined in the Directives list of harmonized standards.
It is important that you prepare to meet the new requirements, so you are ready for certification soon after your Notified Body is designated. You can find out more about the transition on our dedicated webpages: MDR revision or IVDR revision.
BSI is a full scope Notified Body to the Medical Device Directives. This means whatever type of device a manufacturer wishes to market in Europe, where CE marking is a legal requirement, BSI has the technical expertise to provide appropriate conformity assessment services.