Reading the newly published Medical Device Regulation (EU-MDR) you probably did not notice a huge impact right away, but over time the huge consequences are getting clearer. With the publication, the transition period has started, and your time left to get your data and documentation into EU-MDR compliance is ticking away rapidly.
This blog looks at the impact of the new regulation on clinical studies you already performed, and clinical data you collected under the MDD,
and challenges everyone’s decision to not perform additional clinical trials or PMCF studies.
Most medical device companies that currently sell CE-marked medical devices are getting nervous thinking about implementation of EU-MDR compliance and new certification. Especially related to the necessity to present sufficient clinical evidence to support the general safety and performance requirements. Let’s look into this step by step.
Waiting is not an option
In case of changes and uncertain situations quite a few people kind of ‘freeze’. To identify how to become and stay EU-MDR compliant this would be a bad option. Communicating, analyzing, acting and swift decision making are key to get EU-MDR compliant as soon and as smooth as possible.
First, talk to your Notified Body! Notified Bodies are also still working on implementation of the EU-MDR. As there is insufficient time for full harmonization, the interpretation and implementation of the EU-MDR can differ between Notified Bodies. Be open about the issues you face and the worries you have. A proactive approach will initiate goodwill and provides valuable feedback from your Notified Body. They are unable to advise you, but are able to provide feedback that guides you in the right direction.
Analyze your product portfolio. Look closely into the clinical evaluation reports (CERs) of all your products. Is the classification still valid under EU-MDR? What sources of clinical evidence have you been using in your CER? Is your justification for not performing a clinical investigation and/or not implementing post market clinical follow-up (PMCF) still valid, and sustainable under the EU-MDR?
After you have inventoried what clinical data are the basis of your current CER, start your gap analysis. The MDR mentions:
“A clinical evaluation shall follow a defined and methodologically sound procedure based on:
a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where the following conditions are satisfied:
it is demonstrated that the device subject to clinical evaluation for the intended purpose is equivalent to the device to which the data relate, and
the data adequately demonstrate compliance with the relevant general safety and performance requirements.
a critical evaluation of the results of all available clinical investigations
consideration of currently available alternative treatment options for that purpose, if any”
Is your current CER already in accordance with MEDDEV 2.7.1/rev.4? Do you have a clinical evaluation plan/protocol where you outline the purpose and method of performing your clinical evaluation?
If you use evaluation of scientific literature as a source to demonstrate compliance with relevant essential requirements (general safety and performance requirements), did you obtain this literature in a systematic way with a well-designed and scoped search strategy? Your methods need to be documented transparently to enable review.
Also, your methods of appraising the literature need to be documented to assure your critical evaluation, without any bias or underexposure of unfavorable data.
In case you used scientific literature to demonstrate equivalence in your current CERs, be aware of the changes in using equivalence under EU-MDR. The equivalence route is made less accessible, especially for class III and implantable devices.
If competitor’s equivalent devices form the foundation of your class III device CERs, you should really reconsider if you want to continue the equivalence route. I say this because if you do not have contractually arranged full access to the files of these equivalent devices, you might face serious problems. As your competitor might be unwilling to grant you such access, initiating PMCF studies or other pro-active PMS activities (e.g. registries) to obtain own clinical data of your own device, limits your dependency on equivalence and brightens your outlook to EU-MDR compliance.
Results of clinical investigations and/or PMCF studies that you already performed in the past or that are currently ongoing, will be very valuable for your clinical evaluation. A critical re-evaluation of these results in all cases is necessary to bring your CER to the required level. ISO 14155 (GCP) compliance is indispensable. Measures to prevent any form of bias should be considered and where possible implemented. For example; randomization, independent monitoring/auditing, power, data collection methods that do not bias data integrity, objective endpoints etc.
Clinical data collected in clinical investigations that lack sufficient ISO 14155 compliance are at risk of providing insufficient clinical evidence. Data collected with low scientific value are a waste of money and time and might not be accepted by your Notified Body moving forwards. Historic trials performed in Asia (e.g. China, India) and Africa will be evaluated under a magnifying glass when it comes to GCP compliance.
After analyzing your product portfolio and associated CERs, the decision-making process is an important step towards EU-MDR compliance. Some products might really lack sufficient clinical evidence and might indispensably require some form of active data collection (PMS/PMCF). Is the product worth it? If the profits are very limited you might consider to phase out the product and not recertify under EU-MDR. If the product is your main source of income, an investment in clinical data collection will be essential.
If there is a new product in your pipeline that most probably will replace another, non-MDR compliant product, you might decide to focus on getting the file and clinical data collection for the new product, in a fully MDR compliant way. Get CE-market asap, instead of investing in the old product.
Plan of action
To answer the starting question; “Do you have clinically sufficient evidence for future MDR compliance?”, that really depends on the current quality and quantity of your clinical evidence.
An action plan to find out:
Don’t wait, start investigating your product (portfolio) and CER(s) right now
Communicate with your Notified Body about your plans and worries
Critically and objectively analyze the foundation of your CER(s)
Consider the value of this basis. Are they ISO 14155 compliant, non-biased
, well-powered data, etc.?
Decide where to invest and where to say goodbye
Get the resources to prepare your EU-MDR compliance!
If you require support or resources, do not hesitate to contact Qserve’s team of experts.