Vasiljeva, K, van Duren, BH orcid.org/0000-0003-1877-8227 and Pandit, H orcid.org/0000-0001-7392-8561 (2020) Changing device regulations in the European Union – impact on research, innovation and clinical practice. Indian Journal of Orthopaedics, 54 (2). pp. 123-129. ISSN 0019-5413
Abstract
Background
Up until 2017, medical devices were placed on the European Union’s (EU) single market in accordance with either Medical Device Directive 93/42/EEC for general medical devices or Medical Device Directive 90/385/EEC for active implantable devices. However, some devices that complied with these directives still failed catastrophically. In the orthopaedic device field, these failures were most pronounced in metal-on-metal hip devices causing severe patient morbidity with increased need for revision surgery which had unpredictable outcomes. Subsequently, the newly introduced Medical Device Regulations 2017/745 are aimed at addressing patient safety based on previous experience and thorough device assessment prior to and post-release on the EU single market; to accommodate for this they are substantially different (and more stringent). This poses a greater challenge for manufacturers and regulatory bodies in terms of time and resources.
Methods
A review of the EU directives and published literature was undertaken. This review provides the rationale behind this change and its potential impact on research, industry, and clinical practice.
Discussion
The change in legal requirements for the medical devices to be put on the EU single market ultimately leads to increased patient safety, which is supported by clinical professionals. The new requirements for data transparency, post-market surveillance, and implant information availability increase the chance of catastrophic failure prevention. However, the exact method of implementation remains uncertain, and some essential rules on the data requirements for compliance have not yet been published by the EU. These limitations may limit the availability of products on the market including withdrawal of existing devices and a decrease in new medical device innovation. It is speculated that lack of new technologies within the medical device area can dramatically affect patient safety itself by not allowing potentially safer materials and methods on the EU single market, as the focus for the manufacturer becomes existing devices.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © Indian Orthopaedics Association 2020. This is an author produced version of a paper published in the Indian Journal of Ortheopaedics. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | Medical device regulation; Medical device directive; Joint replacement |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Engineering & Physical Sciences (Leeds) > School of Mechanical Engineering (Leeds) > Institute of Medical and Biological Engineering (iMBE) (Leeds) The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Institute of Rheumatology & Musculoskeletal Medicine (LIRMM) (Leeds) > Orthopaedics (Leeds) |
Funding Information: | Funder Grant number Versus Arthritis (formerly ARUK) 22036 |
Depositing User: | Symplectic Publications |
Date Deposited: | 19 Aug 2019 09:37 |
Last Modified: | 06 Feb 2021 01:38 |
Status: | Published |
Publisher: | Springer |
Identification Number: | 10.1007/s43465-019-00013-5 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:149790 |