MDR 2020 – Are you on the right track?

Strategies for the timely creation of a clinical evaluation report (CER)

 

With the introduction of the MDR (EU Regulation 2017/745), manufacturers of medical devices are faced with enormous challenges. Additional capacities are necessary to completely revise the documentation of all products. Not only the usability file, classification and large parts of the technical documentation including the clinical evaluation are affected and need to be reconsidered and – if required – adapted, but the introduction of missing processes for post-market surveillance, risk management and post-market clinical follow-up also necessitates additional manpower.

Even if you have already adopted measures to be MDR compliant by 2020, it is often difficult to gauge whether you are in keeping with your schedule. It is important that the clear focus of your strategy is reaching the goal of being “MDR compliant”. By documenting the strategy and reaching milestones, it is possible to prove to the notified body that you are already concerning yourself with conforming to legal requirements.

Yet even with the best planning, new obstacles will be encountered again and again. Here are a few tips on how you can overcome barriers in the extensive field of clinical evaluations.

Resource planning: There are not too many service providers with considerable knowledge in creating clinical evaluation reports (CERs). Even if you are not planning on having all or most of your CERs created until 2019, you should already be contacting and selecting service providers. It is to be expected that resources at experienced agencies or CROs are getting tighter and tighter the closer 2020 approaches. Get ahead by securing capacities at qualified providers.

Quality of the documentation: Knowledge of the content requirements for the needed documents is often very different within a company. It is sometimes not clear to many involved how the departments work together and what information is needed from what side. Inform contributors about the requirements to enhance awareness and achieve better quality in the long run.

Duration of the creation of a clinical evaluation report: Creating a clinical evaluation report according to MDR requirements is very time-consuming. The creation is then also often delayed because documents are not yet available or are of poor quality. Commissioning inexperienced medical writers can also markedly increase the time required for creating CERs.

Delays due to non-compliant documentation: If the existing documents do not (yet) comply with the requirements of the MDR, it seems sensible at first glance to postpone the clinical evaluation report until the documentation complies with MDR standards. However, this means that you must knowingly accept the resource shortages of external providers. It is therefore advisable to start creating the CER with the existing documentation and have the clinical evaluation report updated once MDR conformity is achieved, which can be done relatively quickly.

To counter difficulties with the documentation’s quality, MEDICRO offers workshops tailored to your company’s needs. Small groups discuss topics aimed at improving the quality and efficiency during the creation of documentation. Among other things, the following questions may be covered:

  • What documents are needed for the clinical evaluation report?
  • What do these documents need to include? What mistakes can be avoided when creating the clinical documentation?
  • How will the different departments work together? Who will be responsible for what?
  • What claims are legitimate and how can claims be verified?
  • What is the difference between intended use and intended purpose?

It goes without saying that we can offer quality improving workshops for all aspects of the Medical Device Regulation. Please contact us and we will develop a concept with you for training your employees, provide consultation for introducing processes, or support in evaluating existing measures.

We will also gladly create your clinical evaluation report(s), a detailed schedule and resource plan, and a concept for the timely completion of all your clinical evaluation reports. For a non-binding quote, simply contact us.