Impact of new legislation on the availability of paediatric medicaldevices in the European Union with an emphasis on paediatric gastroenterology, hepatology and nutrition-Reference-Cited by-同舟云学术

Impact of new legislation on the availability of paediatric medicaldevices in the European Union with an emphasis on paediatric gastroenterology, hepatology and nutrition

Published:2023-12-20 Issue: Volume: Page:
ISSN:2691-171X
Container-title:JPGN Reports
language:en
Short-container-title:JPGN rep.

Author:

Baumann Ulrich¹,Bronsky Jiri²,Dolinšek Jernej³,Fewtrell Mary⁴,Indolfi Giuseppe⁵,Kolaček Sanja⁶

Affiliation:

1. President of ESPGHAN

2. ESPGHAN Nutrition Committee Chair

3. ESPGHAN Committee of Gastroenterology Chair

4. Secretary General of ESPGHAN

5. ESPGHAN Committee of Hepatology

6. ESPGHAN Liaison officer

Publisher

Wiley

Subject

General Earth and Planetary Sciences,General Environmental Science

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jpr3.12023

Reference9 articles.

1. European Commission. 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);2017. Accessed August 10 2023.http://data.europa.eu/eli/reg/2017/745/oj

2. European Medicines Agency (EMA). Medical devices. Accessed August 10 2023.https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

3. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042

4. European Commission. Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices;2023. Accessed August 10 2023. https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf

5. Biomedical Alliance Europe. Clinicians concerned about limited availability of medical devices: report of the BioMed Alliance survey conducted in cooperation with the ESC and EFORT;2023. Accessed August 10 2023. https://www.biomedeurope.org/images/news/2023/Report_survey_results_v3.pdf