Preparing For Your Clinical Evaluation Report
Preparing For Your Clinical Evaluation Report
Aligning with MEDDEV 2.7.1 and the MDR
The newest revision has defined, clarified and tightened guidance on clinical evidence requirements for unapproved technologies as well as products that have been on the market for an extended period.
“It was written bearing in mind the changes through the MDR, and has very much tightened up on clinical.” Explained Anwen Evans, former Certificate Decision Maker, Underwriters Laboratories in an interview with Q1 Productions. “The MEDDEV reflects the direction that the MDR is going in. Which is a big help to manufacturers.” A lot of changes have been set to ensure more safety for patients and practitioners, more clinical data to prove product safety and effectiveness, more scrutiny from authorities, and more clinical testing altogether.
MEDDEV 2.7.1 rev 4 is currently active, implying that notified bodies will seek to review all device’s CERs, regardless of when the device was approved and placed on the market. Manufacturers must be detailed and transparent about the methods used and steps taken during the clinical evaluation process and provide extensive data analysis, process logs and lists of references. With no formal consensus on the level and volume of acceptable data, manufacturers must actively analyze product portfolios, conduct impact assessments and collect as much clinical data as possible to satisfy new requirements.
There are five stages from the scoping and clinical evaluation plan to finalization of the CER.
- Scoping & Clinical Evaluation Plan
- Identification of Pertinent Data
- Appraisal of Pertinent Data
- Analysis of Clinical Data
- Clinical Evaluation Report
The overall concept of clinical research does not change; the manufacturer will still use clinical data to demonstrate compliance. Data is still analyzed based off premarket and postmarket investigations. The impact comes into effect as the different level of details, systems and timing.
The products most impacted by the changes are high-risk devices. The CER for high-risk is more detailed and needs more data than before.
High-risk and innovative products now have to update their CER annually and anytime new data is collected. Even high-risk devices that were considered equivalent must be updated.
Equivalent devices are newly defined as almost identical products. There is great detail in MEDDEV rev 4, Appendix 1, defining what equivalence now means. Clinical, technical and biological characteristics must be considered for the demonstration of equivalence.
The second most significant impact is that it is no longer a one-time update, but a continual update. Starting in the design stage, clinical evaluations are required. It is an ongoing update throughout the entire life-cycle of a product, and all documentation must match. While high-risk devices must be submitted every year, manufacturers must justify the frequency of updates for lower risk devices. These justifications must consider design changes, risk, and new data. They should do this every two to five years.
The third impact is that the summary of clinical data must be made publically available. There will be a summary of clinical data available contrasted to an assessment of complaints and the volume of sales. A postmarked surveillance report updated annually with key information of what the manufacturers knows about the safety of the product and the performance of the product on an ongoing baseis. It is also required to include methods and steps taken to collect data. The CER will have a log of how and when the evaluation was performed. Therefore, it will be comparable with what competitors have in the market, so it will impact both the visibility of the product and their problems compared with the others. Not only effecting transparency of sales, but also providing journalists with and abundance of information for potential public-affairs issues such as recalls.
With the transition into the new Medical Device Regulation, device manufacturers are required to obtain the new CE mark for existing as well as new products. As there are no grandfathering clauses enabling a shift to the new CE mark outside of clinical testing, legacy products that have been on the market for years also need to undergo further testing under the new rules. Clinical teams are therefore currently asked to assess legacy device trials feasibility, with a focus on the overall time and cost to forecast, in order for the corporation to make enlightened decisions about legacy product lines to keep on the market or terminate. “At this moment the lack of clinical data from manufacturers that are early on in the interpretation indicates that they might have to say farewell to using up to 50 percent of their portfolio” explained Gert Bos, Advisor CIE Taskforce on MEDDEV 2.7.1 to Q1 Productions in an interview.
The CE mark within this legislation is a game changer. It’s not just a brief update of existing documentation to be able to show compliance. It’s a new concept altogether, with new thinking, and enhanced expectations. It is stricter, and for products to stay on the market in the new regime, especially for higher risk products, there needs to be sufficient clinical data. There is an emphasis on the word sufficient. It has not been defined yet, so we are all trying to figure out what that means. One thing is certain, it is much more than ever before.
“Manufacturers should be almost ready for the changes, but in reality, the majority have barely started clinical evaluation reports compliance with the new guidance,” said Gert Bos. Staying up to date on clinical news is more important than ever. That’s why, for the 10th year in a row, clinical executives will meet for the EU Device Clinical Research Conference in Berlin on March 20-21, 2018.
This conference will continue to provide executives with an unparalleled educational opportunity, through a distinct mix of session formats. Traditional presentations delivered by high-level speakers from the industry, competent authorities and notified bodies will be followed by interactive group discussions as well as engaging workshops focusing on the practical aspects of new rules implementation and more. Further topics of the utmost importance will also be debated, such as the pros and cons of outsourcing trial operations, meeting ethics committees’ expectations and clarifying clinical evidence demands for reimbursement. With such a variety of formats, speakers, and topics, the 10th Annual Q1 European Medical Device Clinical Research conference is a must-attend for forward-thinking clinical affairs professionals.