New medical device regulations: the regulator’s view

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

Orally ingestible medical devices for gut engineering

“…Previously in the EU, Class I or low risk devices needed merely a "self-declaration" by the manufacturer. However, improvised EU's Medical Device Regulation act, which will apply from May 2020 (postponed until May 2021 due to COVID-19 crisis), puts stringent controls on active medical devices [102]. Invasive control systems, such as active therapeutic devices (with integrated or embedded diagnostic function), which were previously being assigned to Class IIb, will now adhere to the stringent requirements of Class III.…”

Lääkintälaitteiden valmistajien valmistautuminen uuteen lääkintälaiteasetukseen (MDR)

“…Melvin ja Torre (2019) toteavat, että Euroopassa on arvioiden mukaan 500 000 erilaista lääkintälaitetta ja ne koskettavat melkein jokaista ihmistä jossain vaiheessa elämää. [10] Suomessa omahoidosta ja itsemonitoroinnista syntyvää hyvinvointitietoa kuten esimerkiksi verenpaineen tai verensokerin mittaustuloksia voidaan tallentaa Kantaan kuuluvaan Omatietovarantoon. Jatkossa tietoja voidaan jakaa terveydenhuollon ammattilaisten kanssa [11] Tämä tutkimus laajentaa ja jatkaa vuonna 2016 valmistuneen pro gradu -tutkielmani aihepiiriä, jossa tarkasteltiin suomalaisten terveysteknologiayritysten tietojohtamista.…”

Design, Implementation and Management of an International Medical Device Registry

“…Most are supported as part of a regional or national mandate. Thorough overviews to developing a safety registry can be found in several publications [IMDRF 2015, Gliklich 2020, Zaletel 2015] and for a medical device registry [Mandavia 2018, Banerjee 2019, Medtech Europe 2017, Melvin 2019]. It is rare for a patient-related outcomes registry to be corporate funded and international.…”