To achieve regulatory compliance and sales clearance in Europe, all medical devices must be supported by a CER Clinical Assessment Report documenting the entire clinical assessment process. This is not a new requirement for device manufacturers, but with high-profile scandals related to medical devices calling into question the adequacy of existing criteria, the new MDR Medical Device Regulation introduced in May 2017 tightened the requirements. for CERs.

Although we are more than a year into the transition period for the MDR, there is still confusion about these requirements. Considering that all medical devices must be submitted for a new CE mark* under the regulation, any lack of clarity is worrying for manufacturers as it delays the compliance process.

Manufacturers must be able to present properly documented CERs during inspections; Otherwise, they risk having their products withdrawn from the market, a detrimental outcome for their business and potentially for healthcare providers and patients who need specific devices. Rather than wait and see, companies should start reviewing their existing CERs immediately.

Existing guidance for writing clinical evaluation reports for medical devices

To get started, manufacturers should refer to the guidance on the CER approach published in the MEDDEV 2.7/1 Rev.4 document, which is now in its fourth iteration and represents the highest standards for CERs. The MDR closely reflects the guidance of MEDDEV, and although the regulation will not fully come into force until 2020, NB Notified Bodies, the EU organizations designated to assess conformity, expect manufacturers to be fully up to date with MEDDEV, not has a transition period.

Getting the right data for clinical assessment reports

Before compiling reports, manufacturers need to know if they have the correct data available. Manufacturers must be able to demonstrate:

that the device achieves its intended performance;that known and foreseeable risks, and any adverse events, are minimized and are acceptable when weighed against the benefits of the intended use;that any claims about the performance and safety of the device are supported by adequate testing.

For products already on the market, companies must conduct ongoing post-market surveillance to collect data on actual usage of their devices; This identifies unforeseen risks and complications, as well as areas for improvement. If they fail to do this, they will have to start the time-consuming and expensive data collection process.

For new products, companies can no longer rely on data from equivalent devices made by other companies; since the MDR requirements are more stringent, the necessary information will only be available internally. This means that there will be a boom in clinical trials and companies. That delay will make it difficult to access the qualified personnel and resources they need. Best practice RCEs can take up to three months to complete, so if data, expertise, and/or resources are lacking, the expected duration can be significantly longer.

Standardize processes to avoid headaches

If they haven't already, companies need to approach CERs as a recurring activity throughout product lifecycles and develop efficient company-wide procedures so that all the information needed for a report is always available; this includes comprehensive product information, post-market surveillance data, and risk management.

When it comes to writing reports, companies can make the process more efficient through a SOP Standard Operating Procedure where the staff can follow the correct process with the help of standard templates. However, reports must be written by trained professionals; Existing guidance can be confusing at times and if companies write reports according to their own interpretation of the regulation, they risk being sent back. The investment required for training in Clinical Evaluation Consultants assessment and related processes can be substantially less than the cost of setting CERs after NB review.

The key is the hiring of specialized writers

Some of the expertise required for CERs may already be available internally, so manufacturers should not hesitate to distribute the tasks to the appropriate teams within the company. Quality and compliance activities do not have to be limited to a single person or team within a business, especially given their importance.

The overall quality of the CER is likely to improve if different skill sets are implemented, and this allows regulatory staff to focus on other important responsibilities as well. Companies that do not have the right in-house skills may seek help from outside providers to fill in the gaps and provide specialist advice.

Looking to the future

The sheer scale of the new Medical Device Regulation means that many manufacturers are faced with the daunting task of reviewing documentation for their entire product portfolio. According to a recent report, 58% of medical device companies report that they do not have a strategy in place to remedy gaps in their clinical data or processes for data collection.

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 and comprehensive strategy for CER success.

Medical devices require the CE mark before they can be sold in the European Union. The CE mark shows that the device has been evaluated and meets all necessary health and safety requirements defined by the EU.

When submitting devices for a CE mark, manufacturers must provide technical documentation including the Clinical Evaluation Report.

Under the Medical Device Regulation, every device must be resubmitted for CE marking before the end of the transition period in 2020.