New medical device regulations: the regulator’s view

Author:

Melvin Tom1,Torre Marina2

Affiliation:

1. Medical Officer, Health Products Regulatory Authority, Dublin, Republic of Ireland

2. Engineer, Senior Researcher, Istituto Superiore di Sanità, Rome, Italy

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

Publisher

Bioscientifica

Subject

Orthopedics and Sports Medicine,Surgery

Reference17 articles.

1. No authors listed. Consolidated version of the Treaty on the Functioning of the European Union – Part Three: Union Policies And Internal Actions – Title XIV: Public Health – Article 168 (ex Article 152 TEC). Official Journal 09/05/2008;115:122–124. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A12008E168 (date last accessed 18 September 2018).

2. No authors listed. 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 (Text with EEA relevance). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745 (date last accessed 18 September 2018).

3. No authors listed. 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 (Text with EEA relevance). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746 (date last accessed 18 September 2018).

4. Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). Opinion on the safety of metal-on-metal joint replacements with a particular focus on hip implants, 2014. https://ec.europa.eu/health/sites/health/files/scientific_committees/emerging/docs/scenihr_o_042.pdf (date last accessed 27 August 2018).

5. European Commission. Press Release – Medical devices: European Commission calls for immediate actions – tighten controls, increase surveillance, restore confidence, (2012). http://europa.eu/rapid/press-release_IP-12-119_en.htm?locale=en (date last accessed 28 August 2018).

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