Before a medical device or in vitro diagnostic (IVD) can be sold in the EU Zone, it must have a CE Mark.
CE marking demonstrates that the product has met all of the requirements of the Medical Devices Directive (MDD 93/42/EEC), In Vitro Diagnostic Device Directive (IVDD 98/79/EC) or the Active Implantable Medical Device Directive (AIMDD 90/385/EEC), where applicable.
The requirements for obtaining CE marking include the preparation of a Technical File or Design Dossier which provides the evidence to demonstrate compliance with the MDD/IVDD/AIMDD.
The quality system requirements in Europe, Canada, Japan, Australia and other countries are laid out in the ISO 13485:2003 standard which is designed specifically for medical device manufacturers. While voluntary for manufacturers selling in Europe, most companies choose to apply this standard to demonstrate compliance with the Directives.
Spectrum offers guidance on CE marking requirements, regulatory strategies for the commercialisation of new products, implementation of management systems to ISO 13485:2003 and preparation of the Technical File or Design Dossier.
We also offer training, gap analysis and auditing.
European Directive 2007/47/EC, which amends the MDD 93/42/EEC, puts greater emphasis on clinical data and a Clinical Evaluation Report is now a mandatory component of the Technical File. ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
At Spectrum, we use our wide-ranging experience in preparing clinical documentation to present newly generated clinical data. Through literature searching we find, review and present available clinical data on a medical device in a way that clearly and comprehensively demonstrate s its clinical safety and performance. Spectrum has expertise in writing Clinical Evaluation Reports, or can help to develop a process for this.
On the practical side, our consultants provide training for clinicians, clinical specialists and sales agents, ensuring confident, proficient and safe use of medical devices and diagnostics.
Medical Devices: Usability Testing
The primary standard for medical device usability is EN 62366, Medical devices – Application of usability engineering to medical devices. This standard specifies a process for analysing, specifying the design, and verifying and validating device usability. EN ISO 14971, Medical devices — Application of risk management to medical devices is the European harmonised standard for device risk management and is necessary for achieving conformity with the usability standard.
Spectrum offers the services of experts in the testing of devices with real users.
This can take place either during development or post-launch and involves independently and iteratively testing products to ensure their ease of use.
Data from Usability Testing can prove product claims and minimise risk.
To find out more about these and other regulatory affairs services from Spectrum, please call us on +44 (0)1403 320280 or contact us by email.