The MHRA has published Guidance on the EC Medical Devices Directives.
The guidance document is a comprehensive document, and covers the regulations in some detail:
- The Medical Devices Regulations 2002
- The Active Implantable Medical Devices Directive
- Medical Devices Directive
- In Vitro Diagnostic Medical Devices Directive
The Guidance provides help interpreting these regulations in a number of Specific Areas:
- Clinical Investigtions in the UK
- Is a Clinical Investigation Required
- Special Clinical Investigations
- Changes in intended use
- Comparative Studies
- Prototype Devices
- Clinical Investigations also submitted to the FDA of other Non-EU Regulatory Authorities
- In-house manufactured medical devices
- “Off-Label” use
- Making an Application for Pre-clinical Assessment
- Competent authority processing of the clinical investigation
- Documentation required for all submissions
- Clinical Investigational Plans
- Documentation to be kept available
- Special features of clinical trials
- How your application will be handled by the UK-competent authority
- Adverse event handling
The publication is detailed and covers a number of areas in detail, it is recommended reading for anybody developing a medical device.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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