As of May 26, 2021, companies selling medical products within the European Union (EU) must comply with the EU MDR (Medical Device Regulation), which governs the clinical investigation and sale of medical devices. It replaces the MDD (Medical Device Directive) and the AIMD (Active Implantable Medical Devices) and entails some significant changes. These include more rigorous controls on Clinical Evaluation Reports (CERs) and higher expectations regarding the clinical data for medical devices and their CE marking (Johner Institute, 2020). In short, any medical device manufacturer wishing to sell or continue selling their products in the EU must prepare to meet much stricter regulatory demands and therefore adapt their data collection methods. Electronic data capture (EDC), a system of capturing and managing data on a digital platform, is one way to efficiently collect data in line with the EU MDR. However, according to our MDR survey from spring 2020, just 33% of manufacturers already work with EDC, 48% still use paper and 69% use Excel. In light of the profound regulatory changes brought about by the EU MDR, there are some good reasons to believe that paper-based data collection methods will be impossible to sustain in the post-MDR era. Companies still relying on these methods will likely struggle to meet the new requirements. Below, we list five facts that underline why digital solutions will be crucial for complying with the EU MDR.
1) Monitoring system according to EU MDR
According to Article 83 of the EU MDR, manufacturers are obliged to “systematically and actively gather, record and analyse relevant data on the quality, performance and safety of a device throughout its entire lifetime”, for each medical device, which has been introduced on the market (EU-MDR, Art. 83). To this end, quality management should establish a “comprehensive post-market surveillance system” based on the specific post-market surveillance plan (EU-MDR, 74).
Due to the significant amount of clinical data required, the continuous monitoring of all products’ safety and performance in the market can hardly be done in an “analog” way. The“systematic” collection of clinical data is close to impossible without an EDC system.
Finally, even though the EU MDR does not explicitly mention an obligation for electronic data capture, the requirements mentioned in Art. 83 of the regulation speak in favor of digital data collection.
2) Data collection according to the principle of good clinical practice
In addition, the EU MDR refers to the “ISO 14155:2018 standard on good clinical practice”, which should serve as the basis for the rules on clinical investigations of medical devices (EU MDR, 64). The principle of good clinical practice prescribes the “accuracy, completeness, readability and timeliness” (ISO 14155:2018, Art. 7.8.1) of collected data. It also states that the documents relating to a clinical trial must be “identifiable, traceable and adequately stored to provide a complete history of the trial” (ISO 14155:2018, Art. 7.8.1).
Electronic data capture, storage and processing is much more likely to meet the principle of good clinical practice. For instance, contrary to digital solutions, data in paper form can be lost, is much more likely to result in errors and is sometimes written in an illegible way. The ISO standard therefore also suggests an electronic solution for capturing and managing clinical data.
3) The EUDAMED database
Another aspect which speaks for the use of digital solutions is the compatibility with the EUDAMED database (European Commision, EUDAMED). This database is addressed in Article 34 of the EU MDR and is expected to play a significant role in the post-market surveillance of medical devices as of 2022 (EU-MDR, Art. 34).
Although the EUDAMED database is primarily intended for the exchange of data between the competent authorities, the database also provides interfaces to medical device manufacturers. The manufacturers are obliged to store certain data about the company and its products in EUDAMED, which can either be entered manually via an input mask or uploaded directly in the form of an XML file. Obviously, the latter would be considerably more time- and cost-saving for the manufacturer and can only be done when using a digital solution.
4) Notified Bodies recommend digital platforms
Notified Bodies assess the conformity of medical products before being placed on the market and therefore have all the insight when it comes to meeting regulatory requirements. The former Vice President of TÜV-Süd, Bassil Akra, made a case for EDC systems by recommending “using a digital platform to make the approval processes for medical devices, pharmaceuticals and combination devices in Europe lean.”
5) Johner Institute recommends switching to digital solutions for PMS activities
Last but not least, the Johner Institute also recommends digital solutions for PMS activities. In a recent interview Dr. Andrea Seeck (Lead Johner Institut Post-Market-Services) reported on typical challenges that medical device manufacturers face in post-market surveillance and potential solutions. Dr. Seeck pointed out that they use a software tool to automate PMS activities such as the collection of relevant reports and data.
Taking all these points into account, switching to an EDC solution seems indispensable for manufacturers willing to comply with the high requirements of the EU MDR. Automated, web-based clinical data capture solutions such as Climedo represent a simple, secure and cost efficient way to collect clinical data for the validation and post-market surveillance of medical devices in line with the EU MDR. If you want to learn more about the EU MDR and how to start collecting and managing your clinical data electronically, we would be happy to tell you more about this in a free, personal software demo. Sign up today!