CE Marking
Do you want to place a medical device on the European market?
Do you need to identify an appropriate conformity assessment route to the CE mark?
Have you accurately classified your medical device?
Do you need assistance with a Technical File or Design Dossier?
Are you aware of the amendments to the directives which come into effect from March 2010?
Do you know which Notified Body to select?
Do you need guidance regarding the testing your medical device needs to undergo?
Do you have sufficient clinical data to support CE marking via the clinical literature evaluation route?
Since 1994, Emergo Group (formerly Mediqol) has helped over 200 medical device manufacturers obtain the CE Mark for their products.
We have experience of all three European Directives for medical devices, namely the Medical Device Directive 93/42/EEC (MDD), the In Vitro Diagnostic Directive 98/79/EC (IVDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD).
Our services include:
Compilation of technical files and design dossiers for CE Marking
Technical files prepared by Mediqol routinely follow the recommendations of the Notified Body guidance document, NB-MED/2.5.1/Rec5 regarding construction and content. Emergo Group has adopted this format for almost all of its CE Marking projects in conjunction with a modular construction, which makes for ease of updating individual sections of the documentation as and when necessary. Design dossiers follow a similar format, but include additional detail concerning the design itself – including the design rationale and clinical need, a design inputs / outputs / verification matrix and details of design changes that occur during development. Emergo Group also prepares technical files and design dossiers according to the STED (summary technical documentation) format proposed by the GHTF.
Emergo Group has specialist expertise and experience in the preparation of design documentation for devices either incorporating, or utilising in their manufacture, materials of animal origin (including those devices subject to the requirements of Directive 2003/32/EC). Additionally, we have significant experience and expertise in the preparation of medicinal component documentation for Drug Competent Authority review under the Notified Body consultation process for drug-device combinations.
Risk Management
Preparation of Risk Management reports in line with the requirements of EN ISO 14971:2007. “Medical devices – Application of risk management to medical devices”. An understanding of this document and effectively applying it is fundamental as the risk management report forms a significant element of any technical file or design dossier.
Our approach to risk management follows the risk management process flowchart documented in the aforementioned standard. Particular attention is paid to the selection of personnel to be involved in the risk analysis and to the identification of hazards, to ensure that all known or foreseeable hazards are considered.
Emergo Group typically conducts quantitative risk estimation for each identified hazard, using FMEA and FTA approaches. Typically, the risk estimation is the product of 2 factors (probability of occurrence of a hazard and severity of harm resulting from the hazard); however, Emergo Group is also conversant with the 3-factor approach, whereby a value for probability of detection of occurrence of a hazard is also incorporated into the risk estimation. The quantitative risk estimation is performed both prior to any control measures being introduced, and again subsequent to their implementation, for the purpose of estimating any residual risks. An assessment of the overall residual risk associated with the device is then performed, which includes a discussion of the risk / benefit of all risks that cannot be reduced to an acceptable level. This culminates in a conclusion as to the overall risk / benefit associated with the device, taking into account the intended use, the target population and any existing technologies for the same purpose.
All the aspects of the risk management process described above are documented in a formal risk management report, which ties together the identification of key device characteristics, identification of potential hazards, the initial and residual risk estimation FMEA/ FTA, the risk / benefit assessment of residual risks not reduced to an acceptable level and the overall conclusion. We have successfully employed this approach to risk management for both new devices and for existing CE Marked devices where post-production experience is fed back into the original risk analysis. Emergo Group risk management reports have been subject to review by Notified Bodies and – in the case of drug-device combinations – by MHRA, with no major criticisms.
