The Changing Landscape of European Medical Device Regulations
Patrick D. Mize, Ph.D.
Contact Dr. Mize http://goo.gl/PV31NZ
Advisor: Product Development / Regulatory Services
Marketing a Medical Device or an IVD in the European Union is gated by the assembly of the Technical File and conformity assessment [either self-assessment or through an NB, Notified Body] for the conformity information. Regardless of type or classification, a medical device’s technical documentation is an integral part of its regulatory approval.
The type of technical information included varies depending on the conformity assessment route and classification of the medical device, but the technical documentation is the main evidence of a device’s compliance to the Essential Requirements for either the Medical Device Directive [MDD] or the In Vitro Diagnostics Directive [IVDD]. Clinical evaluation is an ongoing process conducted throughout the life cycle of a medical device. Regulatory requirements mandate that the Technical File and the Clinical Evaluation Report [CER] are updated on a regular basis.
The CER, which is included in your Technical File or Design Dossier, is required when bringing a medical device to market and helps demonstrate that the device achieves the intended purposes while minimizing any anticipated risks and foreseeable adverse events and conforms to the relevant Essential Requirements of the Medical Directives. The CER summarizes design characteristics, risk evaluation and mitigation, performance and pre-clinical testing of the device, literature reviews / references, clinical trial results, internal CAPA information and post-launch surveillance data.
This compilation provides objective evidence that the device conforms to the relevant Medical Device Directive both at launch and during post-market clinical follow up. Upcoming revisions of the Medical Device Regulations will stress the central role of the Clinical Evaluation Report [CER] in the technical documentation.
The European Community regularly updates the requirements for marketing medical devices in the European Union [EU]. Because of the number of safety incidents and adverse events with metal-on-metal hip implants, silicone breast implants, transvaginal mesh, and IUD medical devices, manufacturers and Notified Bodies [NBs] are under increased pressure to improve public safety.
Historically, the EU harmonized the rules governing the safety and effectiveness (performance) of Medical Devices in the 1990s. Three Medical Device Directives (MDDs) formed the core legal framework:
- Directive 90/385/EEC for active implantable medical devices 1;
- Directive 93/42/EEC for general medical devices2 (CERs are mandatory for CE marked medical devices in all four classes: class I, class IIA, class IIB, and class III); and
- Directive 98/79/EC for in vitro diagnostic medical devices.3,4
- Directive 98/79/EC for in vitro diagnostic medical devices is not the focus of the revisions concerning the need for a Clinical Evaluation Report as such for implantable and general Medical Devices, but all the elements of the CER are to be addressed in the Essential Requirements in Annex I of the IVDD Directive.