References

European Commission, Medical Devices: Factsheets and Step by Step Guides: https://ec.europa.eu/health/md_newregulations/publications

References

FDA, ”Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway”: https://www.fda.gov/media/130864/download

FDA, ”Conventional Foley Catheters – Performance Criteria for Safety and Performance Based Pathway”: https://www.fda.gov/media/130865/download

FDA, ”Safety and Performance Based Pathway”: https://www.fda.gov/media/112691/download

References

European Medicines Agency, “Launch of public consultation on joint network strategy to 2025”: https://www.ema.europa.eu/en/news/launch-public-consultation-joint-network-strategy-2025

References

European Commission Implementing Regulation (EU) 2020/1207, Official Journal of the European Union: https://eur-lex.europa.eu/eli/reg_impl/2020/1207/oj

Medical Device Regulation (EU) 2017/745, Official Journal of the European Union: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745

References

“Unique Device Identification (UDI) System – FAQs”, European Commission: https://ec.europa.eu/docsroom/documents/42641?locale=en

“Eudamed – requirements for all medical device manufacturers”, CEPK: https://cepk.dk/blog/eudamed-requirements-for-all-medical-device-manufacturers

Medical Device Regulation (EU) 2017/745, Official Journal of the European Union: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745