logotype
Search
Become a partner

CE-märkning

CE marking [ENGLISH]

Certification mark placed on a medical device by the manufacturer to declare that the device meets the essential requirements outlined in the European Medical Device Directive, indicating that the device is fit for its intended purpose and meets safety legislation, and is therefore legally allowed to be present on the market within the European Union.

CE-märkning [SWEDISH]

Certifieringsmärke placerat på en medicinteknisk produkt av tillverkaren för att visa att produkten uppfyller de väsentliga kraven i det europeiska direktivet om medicintekniska produkter, vilket indikerar att produkten är lämplig för sitt avsedda ändamål och uppfyller säkerhetslagstiftningen, och därför är lagligt får finnas på marknaden inom Europeiska unionen.

2024-01-29

Search in ATMP dictionary

Resources and references

Definitions have been translated into the Swedish language from the following sources:

  1. 1. American Society of Gene and Cell Therapy Glossary https://www.asgct.org/education/more-resources/glossary
  2. 2. Clinical Trials Information System https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/clinical-trials-human-medicines/clinical-trials-information-system
  3. 3. EMA Glossary of Regulatory Terms https://www.ema.europa.eu/en/about-us/glossaries/glossary-regulatory-terms
  4. 4. EMA Medical Terms simplifier https://www.ema.europa.eu/en/documents/other/ema-medical-terms-simplifier_en.pdf
  5. 5. Glossary of Terms used in EU Clinical Trials Register https://www.clinicaltrialsregister.eu/doc/EU_Clinical_Trials_Register_Glossary.pdf
  6. 6. Glossary of Terms U.S Food and Drug Administration https://www.fda.gov/patients/clinical-trials-what-patients-need-know/glossary-terms
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms” https://www.genome.gov/genetics-glossary/m#glossary
  8. 8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
  9. 9. Toolkit For Patient Focused Therapy Development Glossary https://toolkit.ncats.nih.gov/glossary-2/

Feedback and comments on the word description