Position statement: The need for EU legislation to require disclosure and labelling of the composition of medical devices-Reference-Cited by-同舟云学术

Position statement: The need for EU legislation to require disclosure and labelling of the composition of medical devices

Published:2021-05-06 Issue:7 Volume:35 Page:1444-1448
ISSN:0926-9959
Container-title:Journal of the European Academy of Dermatology and Venereology
language:en
Short-container-title:J Eur Acad Dermatol Venereol

Author:

Herman A.¹^ORCID,Uter W.²,Rustemeyer T.³^ORCID,Matura M.⁴,Aalto‐Korte K.⁵,Duus Johansen J.⁶,Gonçalo M.⁷,White I.R.⁸,Balato A.⁹^ORCID,Giménez Arnau A.M.¹⁰^ORCID,Brockow K.¹¹^ORCID,Mortz C.G.¹²,Mahler V.¹³,Goossens A.¹⁴,

Affiliation:

1. Department of Dermatology Cliniques universitaires Saint‐LucUniversité catholique de Louvain (UCLouvain) Brussels Belgium

2. Department of Medical Informatics, Biometry and Epidemiology Univ. Erlangen/Nürnberg Erlangen Germany

3. Department of Dermatology and Allergology Amsterdam University Medical Centres Amsterdam The Netherlands

4. Dermatology Unit Skaraborgs Hospital Skövde Skövde Sweden

5. Occupational Health Unit Finnish Institute of Occupational Heath Helsinki Finland

6. Department of Dermatology and Allergy National Allergy Research Centre Herlev‐Gentofte HospitalUniversity of Copenhagen Copenhagen Denmark

7. Department of Dermatology Coimbra University Hospital and Faculty of Medicine University of Coimbra Coimbra Portugal

8. Cutaneous Allergy Team St. John's Institute of Dermatology Guy's Hospital London UK

9. Department of Advanced Biomedical Sciences University of Naples Federico II Napoli Italy

10. Department of Dermatology Hospital del Mar. Universitat Autònoma de Barcelona Barcelona Spain

11. Department of Dermatology and Allergy Biederstein School of Medicine Technical University of Munich Munich Germany

12. Department of Dermatology and Allergy Center Odense Research Center for Anaphylaxis (ORCA)Odense University Hospital Odense Denmark

13. Med. Faculty Univ. Erlangen/Nuremberg Erlangen Germany

14. Contact Allergy Unit Department of Dermatology University Hospital KU Leuven Leuven Belgium

Publisher

Wiley

Subject

Infectious Diseases,Dermatology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/jdv.17238

Reference30 articles.

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices aDE Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. URLhttps://eur‐lex.europa.eu/legal‐content/EN/TXT/HTML/?uri=CELEX:32017R0745&qid=1617627663915&from=en(last accessed: 15 October 2020).

2. 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. URLhttps://eur‐lex.europa.eu/legal‐content/EN/TXT/HTML/?uri=CELEX:32017R0746&from=EN(last accessed: 10 October 2020).

3. European Commission.Regulatory framework. The new Regulations on medical devices. URLhttps://ec.europa.eu/growth/sectors/medical‐devices/regulatory‐framework_en(last accessed: 26 June 2019).

4. Regulation (EU) 2020/561 of the European Parliament and of the council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions. URLhttps://eur‐lex.europa.eu/legal‐content/EN/TXT/PDF/?uri=CELEX:32020R0561&from=EN(last accessed: 5 May 2020).

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