The impact of the European Union’s Medical Device Regulation on orthopaedic implants, technology, and future innovation

Author:

Staats Kevin1ORCID,Kayani Babar1,Haddad Fares S.2345

Affiliation:

1. Department of Trauma and Orthopaedics, University College Hospital, London, UK

2. Department of Trauma and Orthopaedics, University College London NHS Hospitals, London, UK

3. Princess Grace Hospital, London, UK

4. The NIHR Biomedical Research Centre, UCLH, London, UK

5. The Bone & Joint Journal , London, UK

Publisher

British Editorial Society of Bone & Joint Surgery

Reference47 articles.

1. No authors listed . Medical Devices - Sector: Overview . European Commission . 2023 . https://ec.europa.eu/growth/sectors/medical-devices ( date last accessed 19 February 2024 ).

2. No authors listed . EU regulation 2017/745 of the European Parliament and the Council of 5 April 2017 on medical devices . Official Journal of the European Union . 2023 . https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745 ( date last accessed 27 February 2024 ).

3. No authors listed . Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices . Official Journal of the European Union . 1990 . https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex:31990L0385 ( date last accessed 27 February 2024 ).

4. No authors listed . Council Directive 93/42/EEC of 14 June 1993 concerning medical devices . Official Journal of the European Union . 1993 . https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31993L0042 ( date last accessed 27 February 2024 ).

5. Faulty hip implant shows up failings of EU regulation;Cohen;BMJ,2012

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