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Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746

U.S. manufacturers of medical devices who are placing their devices on the European market have been facing many challenges relating to the new coming European legislation. The deadline for implementing the European Medical Devices Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746) was postponed from May 2020 to May 2021 due to the COVID-19 outbreak, giving manufacturers more time to prepare.

Manufacturers are required to update their technical documentation regularly using data collected from their users. One of the most critical challenges of this complex new legislation is implementing data collection and analysis requirements in the context of risk management plans for each device. These data collection efforts can potentially become intolerably burdensome for healthcare providers due to a wide variety of medical devices that are used in clinical practice. Hospitals have an obligation to monitor and report medical device failures as well.

Our mission is to ensure the data collection and reporting systems serve both manufacturers and health systems without duplication of effort and without creating an administrative burden for either side. Simultaneously, the data collection and reporting mechanism must comply with the spirit and essence of the new regulations, which is to provide meaningful insight into clinically relevant risks and minimize them in the context of the intended use of the device.

Our team at Veracuity approached the problem holistically. After some experimentation, we designed a solution that we believe will work for all parties involved in the complex medical technology ecosystem. To develop a solution for you as the manufacturer, you must give us access to your technical documentation. Specifically, we ask for a list of your products and corresponding instructions for use (IFU), clinical evaluation reports, risk analysis, and any Post-Market Clinical Follow-Up plans and Field Safety Corrective Actions (FSCA) you may have. We will also give you the option to include Unique Device Identifiers (UDIs) in the reports.

With this information at hand, we will prepare a list of data points that require monitoring depending on your devices’ intended use and benefit: risk profile, as described in your existing technical documentation. Our approach significantly limits the device users’ effort required to fill in and submit a report, as most of the information will already be pre-defined and pre-prepared. We can collect and automatically process a submission-ready adverse incident report for the regulatory authorities. But this is not where our capability ends. As the manufacturer, you will benefit from access to analytical reports required to update your technical documentation instantly using a custom-made dashboard. To provide value for the participating health professionals, we can design a dashboard for the hospital risk management team and grant them access to the relevant subset of data.

More details on this project are coming in the coming weeks, stay tuned!

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[1] Medical Devices Directive, Article 10 and Annexes II, IV, VI and VII https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
[2] Active Implantable Medical Devices Directive, Article 8 and Annexes II, IV and V https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/implantable-medical-devices_en
[3] In-Vitro Diagnostic Devices Directive, Article 11 and Annexes III, IV and VI https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en
[4] Guidelines on a Medical Devices Vigilance System – MEDDEV 2.12/1 rev.8 https://ec.europa.eu/docsroom/documents/32305/attachments/1/translations
[5] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. MDR (EU) 2017/745 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
[6] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. IVDR (EU) 2017/746 https://eur-lex.europa.eu/eli/reg/2017/746/oj
[7] Tim Raemaekers, Dimitris Panidis and Claudius B. Griesinger; Enhancing the effectiveness of medical device incident reporting: final report of the EU pilot on the manufacturer incident reporting form (MIR) https://publications.jrc.ec.europa.eu/repository/bitstream/JRC101761/sfponline%20mir%20form%20pilot%20with%20identifiers.pdf

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