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Review
. 2019 Jun 3;4(6):351-356.
doi: 10.1302/2058-5241.4.180061. eCollection 2019 Jun.

New medical device regulations: the regulator's view

Tom Melvin  1 , Marina Torre  2
Affiliations
Review

New medical device regulations: the regulator's view

Tom Melvin et al. EFORT Open Rev. .

Abstract

Advances in medical device technology have been dramatic in recent years resulting in both an increased number of medical devices and an increase in the invasiveness and critical function which devices perform. Two new regulations entered into force in Europe in May 2017, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR). These regulations will replace the current directives over the coming years. These regulations, for the first time introduce requirements relating to registries.Medical device manufacturers are required to have systematic methods for examining their devices once available on the market, by systematically gathering, recording and analysing data on safety and performance.Registries can assist public health protection in very practical ways, for example, to help urgently identify patients or devices. Registries can also be powerful tools for collecting and appraising real-world clinical evidence concerning medical devices. Clinical investigations are limited in terms of the sample size and the duration of follow-up which can reasonably be expected. Registries may also be the only available tool to examine rare adverse effects, sub-populations or for time durations which it is not possible or feasible to study in a clinical investigation. By ensuring that a core dataset is collected which can be compared to other registries or trial data, it is possible to pool data to better examine outcomes. There are a range of excellent initiatives which have aimed at ensuring the appropriate regulatory application of registry data. Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180061.

Keywords: EU regulations; medical device; registry.

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Conflict of interest statement

ICMJE Conflict of interest statement: TM is employed by the National Competent Authority for Medical Devices in Ireland. MT declares travel/accommodations/meeting expenses unrelated to activities listed.

Figures

Fig. 1
Fig. 1
Timeline for implementation of the new regulations.
Fig. 2
Fig. 2
Types of clinical evidence for medical devices.
See this image and copyright information in PMC

References

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