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Information on legal provisions regulating the field of medical devices

Vytvořeno: 21. 5. 2015 Poslední aktualizace: 21. 5. 2015

Information on legal  provisions regulating the field of medical devices

 

  • Act No. 268/2014 Coll. on Medical Devices and on Amendments to Act No 634/2004 Coll., on Administrative Fees
    • Decree No. 61/2015 Coll. that lays down amount of reimbursement of costs of expert activities executed by the State Institute for Drug Control under the Act on Medical Devices
    • Decree  No. 11/2005 Coll., on implementing some paragraphs of Act on Medical Devices
  • Act No. 22/1997 Coll. on technical requirements on products and  on changes and amendments of some Acts, in wording of  later rules
    • Government Regulation No. 54/2015 Coll., about technical requirements on medical devices
    • Government Regulation No. 55/2015 Coll., about technical requirements on active implantable medical devices
    • Government Regulation No. 56/2015 Coll., about technical requirements on in vitro diagnostic medical devices

 

These legislation is in compliance with the

  • Council Directive 93/42/EEC concerning medical devices
  • Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices
  • Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices
  • Commission Directive 2003/12/EC on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices
  • Commission Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices
  • Commission Decision 2002/364/ES on common technical specifications for in vitro-diagnostic medical devices
  • Commission Decision 2010/227/EU on the European Databank on Medical Devices (Eudamed)
  • Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93
  • Commission Implementing Regulation (EU) No 920/2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices

 

Additional legislation regulated the field of medical devices in the Czech Republic

  • Act No. 505/1990 Coll., on metrology, in wording of later rules
  • Act No. 18/1997 Coll., on peaceful exploitation of nuclear energy and  ionization radiation (nuclear act) and on changes and amendments of some acts, in wording of later rules
  • Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals)
  • Act No. 48/1997 Coll., on general health insurance and on changes and amendments of some related acts, in wording of later rules
  • Act No. 102/2001 Coll., on general safety of products and on changes of some acts (act on general safety of products) in wording of later rules
  • Act No. 526/1990 Coll., On prices, as amended
  • Act No. 265/1991 Coll., on the Competence of the Authorities of the Czech Republic in respect of Prices, as amended
  • Act No. 235/2004 Coll. the Value Added Tax
  • Government Regulation No. 616/2006 Coll., that lays down technical requirements for products relating to their electromagnetic compatibility
  • Government Regulation No. 21/2003 Coll., that lays down technical requirements for personal protective equipment
  • Government Regulation No. 176/2008 Coll., on technical requirements for machinery as amended