To achieve regulatory compliance and authorization for sale in Europe, every medical device must be supported by a Clinical Evaluation Report which documents the entire clinical evaluation process. This is not a new requirement for device manufacturers but with high-profile scandals related to medical devices casting doubt on the adequacy of existing criteria, the new Medical Device Regulation introduced in May 2017 tightened requirements for CERs.
Though we are over a year into the transition period for the MDR, there continues to be confusion about these requirements. Bearing in mind that every medical device needs to be submitted for a new CE mark* under the regulation, any lack of clarity is worrying for manufacturers as it holds up the compliance process.
Manufacturers must be able to present correctly documented CERs during inspections, otherwise they risk having their products removed from the market, a damaging outcome for their business and potentially for healthcare providers and patients that need specific devices. Rather than taking a ‘wait and see’ approach, companies should begin reviewing their existing CERs immediately.
Existing guidance for writing medical device clinical evaluation reports
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To start with, manufacturers must refer to guidance on the CER approach issued in the document MEDDEV 2.7/1 Rev. 4 which is now in its fourth iteration and represents the highest standards for CERs. The MDR closely reflects MEDDEV guidance, and although the regulation doesn’t fully come into force until 2020, Notified Bodies – the EU organisations designated to assess conformity – expect manufacturers to be fully up to speed with MEDDEV, which doesn’t have a transition period.
Getting the right data for clinical evaluation reports
Before compiling reports, manufacturers need to know whether they have the right data available. Manufacturers must be able to demonstrate:
- that the device achieves its intended performance;
- that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of the intended use;
- that any claims made about the device’s performance and safety are supported by suitable evidence.
For products that are already on the market, companies should be conducting ongoing post-market surveillance to gather data on the real-world use of their devices; this identifies unforeseen risks and complications, as well as areas for improvement. If they have been failing to do this, they will have to begin the time-consuming and costly process of collating data.
For new products, businesses can no longer rely on data from equivalent devices manufactured by other companies; as the MDR requirements are more stringent, the information needed will only be available internally. This means there will be a boom in clinical trials and companies that delay will struggle to access the skilled personnel and resources they need. Best-practice CERs can take up to three months to complete, so if there is a lack of data, expertise and/or resources, the expected duration may be significantly longer.
Standardize processes to avoid the headaches
If they haven’t already, companies should approach CERs as a recurring activity throughout product lifecycles and develop efficient procedures across the company so that all the information needed for a report is always readily available; this includes complete product information, post-market surveillance and risk management data.
When it comes to writing reports, companies can make the process more efficient through a Standard Operating Procedure where staff can follow the correct process with the help of standard templates. However, the reports do need to be written by trained professionals; the existing guidance can be unclear at times and if companies draft the reports according to their own interpretation of the regulation, they risk having them sent back. The investment needed for training on clinical evaluation and related processes may be substantially less than the cost of fixing CERs after NB review.
Sourcing specialist writers is key
Some of the specialist knowledge needed for CERs may already be available in-house so manufacturers should not hesitate to distribute tasks to suitable teams within the company. Quality and regulatory compliance activities do not have to be confined to one person or team within a business, especially given their importance. The overall quality of the CER is likely to better if varying skill sets are deployed, and this allows regulatory staff to focus on other important responsibilities as well. Businesses that do not have the right skills in-house can seek the help of external providers to fill in gaps and provide specialist advice.
Looking ahead
The sheer scale of the new Medical Device Regulation means that many manufacturers are faced with the monumental task of reviewing documentation for their entire product portfolio. According to a recent report, 58% of medical device companies report they have no strategy in place to remediate gaps in their clinical data or processes for collecting data. CERs are an essential element of compliance – and also one of the most challenging under the new MDR – so companies should follow the steps outlined above to draft a clear, comprehensive strategy for long-term CER success.
*Medical devices require CE marking before they can be sold in the European Union. CE marking shows that the device has been assessed and meets all the necessary health and safety requirements defined by the EU. When submitting devices for a CE mark, manufacturers must provide technical documentation which includes the Clinical Evaluation Report. Under the Medical Device Regulation, every device has to be re-submitted for CE marking before the end of the transition period in 2020.
Date: October 30, 2018
Source: Technology Networks
