Clinical evaluation is the assessment and analysis of clinical data needed to verify the clinical safety and performance of your medical device. A Clinical Evaluation Report (CER) outlines the scope and context of the clinical evaluation of your device and includes the actual clinical data, the appraisal and analysis stages of the evaluation, and conclusions about device safety and performance.
In 2007, an amendment to the Medical Device Directive MDD 93/42/EEC was made that essentially required every medical device in the EU, regardless of classification, to have a CER. 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 foreseeable risks and adverse events.
Clinical evaluation is an ongoing process that is first conducted during the conformity assessment process leading to marketing and is repeated throughout the life cycle of the actual device and/or substantially equivalent devices. This continues throughout post-marketing with the maintenance of surveillance programs that monitor performance and safety. Depending on the device in question, this can include adverse event reports, results from published literature on the actual device and/or substantially equivalent devices, clinical investigations, and formal post-marketing surveillance, including Post-Market Clinical Follow-Up Studies. This continued evaluation is essential for identifying further risks that occur with use of the device and, if necessary, may result in labelling changes.
The European Commission Guidance MEDDEV 2.7.1 rev. 3 Clinical Evaluation: Guide for Manufacturers and Notified Bodies provides details on the process of conducting clinical evaluations and the requirements for creating a CER, such as (but not limited to) starting with either a Standard Operating Procedure (SOP) or a Clinical Evaluation Plan (CEP) describing the literature search, objectives, methods, and endpoints. The document also provides a list of references that can be useful.
When to Update Your CER
The first priority is to make sure you have a CER. Since the amendment to the MDD went into effect in March 2010, not all manufacturers have created CERs for all of their devices. Still other manufacturers have CERs that are not fully compliant. It is necessary to ensure that your CER complies with the relevant directive: MDD or AIMD.
Once you have a compliant CER for your marketed device, updating it with data from surveillance or ongoing clinical programs is essential, but when should the updates happen? The regulations regarding CER updates are open-ended, leaving the details up to the manufacturer. Notified Bodies (NBs), who are responsible for reviewing clinical evaluations, do not require a set schedule for CER updates but do require manufacturers to have their own processes in place for when and how the CER will be updated.
When establishing your update schedule, you may want to consider the type of device, how often new efficacy and safety data are likely to be published, and how often surveillance programs provide new information on the actual device or equivalent devices. More frequent update protocols (eg, before the yearly NB quality systems audit) may make sense for your higher-class devices, with a less frequent schedule (eg, every 2 years) for lower-class products. Another strategy would be to update your CER in conjunction with your certificate renewal. You are in the best position to determine what is most reasonable, while keeping in mind that unpreparedness at audit time carries a variable amount of risk that has to be balanced with the substantial amount of labor that would be involved in continuously updating your CER.
Ultimately, it is up to you as the manufacturer to monitor the use and status of your device and determine when to update your CER, in conjunction with your Risk Management strategy per EN ISO 14971:2012. Events that are more likely to trigger an update include substantial new data from clinical studies and Post Production surveillance per EN ISO 14971:2012, or significant modification to the device function, design, or materials. Obviously, should the market surveillance raise new risks (recalls, complaints, adverse events, etc) or frequent issues in the performance of the device, you will be required to promptly update your CER to make sure this information is included and your device is safe.
The Clinical Evaluation Process
Once you have set your update processes in place, the update itself will require some time. It is important to identify the steps needed and how long each step will take:
At the end of the clinical evaluation, you should have a document that describes the clinical evidence supporting the use of your device that conforms to the Essential Requirements, as outlined in the appropriate Medical Device Directive.
NAMSA can assist you in:
- Preparing a new CEP and CER;
- Updating your existing CER;
- Conducting a gap analysis of MEDDEV regulations vs your existing CER;
- Upgrading an existing CER to comply with the most recent regulatory requirements;
- Training your staff on how to improve CER preparation or review; and
- Any upfront (eg, pre-clinical services, risk management, quality system support, clinical investigation) or follow up (eg, post market surveillance, post market clinical investigations) processes that may help enrich your CER and optimize acceptance from Authorities.
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- Contact Vincent Legay or Valynda Machen, Senior Medical Research Manager, for further information.
- For more information regarding NAMSA’s regulatory and clinical services, visit our Regulatory page and our Clinical page.
European Commission. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:PDF.
European Commission. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1990L0385:20071011:EN:PDF.
European Commission. Medical Device Directive 2.7.1 rev. 3 Clinical evaluation: Guide for manufacturers and notified bodies. Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_7_1rev_3_en.pdf.
European Committee for Standardization (CEN). EN ISO 14971:2012: Medical devices – Application of risk management to medical devices.