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

The new European legislation places numerous new obligations on manufacturers of medical devices marketed in Europe. The current requirements for reporting adverse incidents of medical devices in Europe are detailed in the Medical Devices Directive (MDD) [1], Active Implantable Medical Devices Directive (AIMD) [2] and In-Vitro Diagnostic Devices Directive (IVDD) [3]. The current procedures are described in Guidelines on a medical devices vigilance system [4].

The manufacturer is obliged to report to the Competent Authorities:

any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the instructions for use, which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health.

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745

The new medical device legislation, MDR (EU) 2017/745 [5] and IVDR (EU) 2017/746 [6], relies on the implementation of the Eudamed electronic system that is not yet functional. The system will inform the public about the devices on the Union market, certificates issued and revoked, clinical investigations and adverse events of devices, and any field safety corrective actions and recalls. Once implemented, Eudamed will enable manufacturers to report serious adverse incidents and support competent authorities’ information exchange. The nomenclature of the new reporting system is still work in progress [7].

MDR 2017/745 modified the terminology and definition:

‘adverse event’ means any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.

‘Serious adverse event’ refers to an adverse event that led to death or serious deterioration in the health such as life-threatening illness or injury, permanent impairment, hospitalization, prolongation of patient hospitalization, led to medical or surgical intervention, resulted in chronic disease, or caused or fetal distress, fetal death or a congenital physical or mental impairment or birth defect.

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745

Sponsors of clinical investigations will record serious adverse events, but also adverse events critical to the evaluation of the clinical investigation and device deficiencies that might have led to a serious adverse event as well as any new findings. Reports from clinical investigations will be clearly distinguished from post-approval use to avoid duplication.

Veracuity’s approach to adverse incident reporting relies on the manufacturer’s technical documentation to specify patient population, detect deviations from intended use, detect failure rate and frequency of complications, and help determine benefit:risk profile of the device. A middle ear prosthesis, an IIb implantable device, is given to patients with, e.g., chronic recurrent otitis media or for the reconstruction of ossicles damaged by cholesteatoma or by trauma. Possible complications include mechanical damage of the device, ear effusion, tympanic membrane perforation, ossicular discontinuity, hematoma, or taste impairment due to damage to the facial nerve.

Veracuity’s team aims to minimize the effort required by physicians and automatically prefill reports with information concerning the product, manufacturer, applicable diagnoses, and possible complications. If relevant, data on efficacy can be collected the same way. In this scenario, pre-operation and post-operation hearing results, including the air-bone gap, would be the most appropriate measure of effectiveness. Veracuity, in cooperation with the manufacturer, can design the data collection, processing, analysis, and reporting system to support mandatory surveillance activities and enables the elegant and painless update of technical documentation throughout the lifecycle of the product. 

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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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