Understanding regulatory and certification requirements
Understanding the roadmap to regulatory approval in different markets is an essential part of any business plan for a new medical technology. Developing the right regulatory strategy enables you to get your products to market quickly by achieving compliance with EU and UK standards.
How we can help
HEE provides relevant, up to date and bespoke guidance on the latest medical devices regulatory requirements. Our services include:
- Device classification including a regulatory roadmap and associated timelines
- An overview of the regulations that apply in different markets (Great Britain, Northern Ireland and the European Union)
- Advice on the different directives governing devices in the EU (currently Medical Device Directive (MDD), Medical Devices Regulation (MDR), In-Vitro Diagnostic Directive (IVDD) & the Active Implantable Medical Device Directive (AIMDD))
- Technical File preparation and selection of Certifying Body.
In partnership with our Medical Regulatory Associate, we are also able to provide:
- International Regulatory Strategy for compliance with FDA and global regulatory requirements
- Quality Systems development to meet European, US and International standards ( ISO 9001 / ISO 13485 / FDA Quality System Regulation)
The CE Mark is the European Community requirement for selling medical devices within the European Union. From 1 January 2021, different rules will apply for medical devices placed on the market in Great Britain and Northern Ireland with the introduction of a new UK Conformity Assessment (UKCA) Mark.
For support with this, or an exploratory conversation about any of the above services, please contact Joop Tanis, Director of MedTech Consulting at Health Enterprise East.