Home / Dz.U. 2001 nr 126 poz. 1380
Law of July 27, 2001, on medical devices.
Ustawa z dnia 27 lipca 2001 r. o wyrobach medycznych.
Type
Law (Ustawa)
Status
repealed (uchylony)
Announced
2001-07-27
Entry into force
2002-10-01
Texts
The consolidated text (tekst ujednolicony) is unofficial; only the signed PDFs from Dziennik Ustaw / Monitor Polski are legally authentic.
Keywords
research and certificationControlpenal provisionsMedical ProductsQualificationsregisterseconomic activitydocumentsclassificationMedical Equipment
Related acts
Repealing Acts (1)
- Law of 20 April 2004 on medical devices · 2004-05-01
Implementing Regulations (10)
- Regulation of the Minister of Health of December 10, 2002 on the essential requirements for medical devices, their accessories, and the procedure for assessing the conformity of medical devices with these requirements.
- Regulation of the Minister of Health of November 13, 2003, on entities authorized to issue documents constituting the basis for placing a medical device on the market and for use, and on the forms of marking with the CE conformity mark
- Regulation of the Minister of Health of December 20, 2002 on the forms of documents concerning clinical trials of medical devices
- Regulation of the Minister of Health of December 20, 2002 on clinical trials of medical devices
- Regulation of the Minister of Health of 18 July 2003 on the detailed conditions for placing on the market and use of medical devices, including in vitro diagnostic devices, intended for veterinary use
- Regulation of the Minister of Health of December 18, 2002 on the forms of registration notifications to the Register of Manufacturers and Medical Devices and the amount of registration fees.
- Regulation of the Minister of Health of December 13, 2002 on the detailed scope of data contained in the Register of Manufacturers and Medical Devices and the Register of Medical Incidents.
- Regulation of the Minister of Health of 2 December 2002 on the classification of medical devices.
- Regulation of the Minister of Health of 15 November 2002 on the detailed requirements for reporting medical incidents and further proceedings after their reporting.
- Regulation of the Minister of Health of 15 November 2002 on entities authorized to issue documents constituting the basis for introducing a medical device into circulation and use, and for marking it with a conformity mark.
Amending Acts (1)
References (2)
Acts referring to this act
- Repealed Acts: Law of 20 April 2004 on medical devices
- Amended Acts: Act of 30 August 2002 on amending the Act on Medical Devices.
- References: Announcement of the President of the Polish Committee for Standardization of 29 July 2003 on the list of harmonized standards
- References: Law of 23 January 2003 on universal insurance in the National Health Fund
- References: Regulation of the Minister of Health of November 22, 2002 on the determination of detailed rules and procedures for suspending and withdrawing medicinal products and medical devices from circulation.
- References: Act of 30 August 2002 on amending the Act on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
- References: Law of September 6, 2001, Provisions introducing the Pharmaceutical Law, the Law on Medical Devices and the Law on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
- References: Law of July 27, 2001, on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
- References: Announcement of the President of the Polish Committee for Standardization of December 19, 2003, concerning the lists of harmonized standards
- Legal Basis: Regulation of the Minister of Health of December 20, 2002 on clinical trials of medical devices
- Legal Basis: Regulation of the Minister of Health of December 10, 2002 on the essential requirements for medical devices, their accessories, and the procedure for assessing the conformity of medical devices with these requirements.
- Legal Basis: Regulation of the Minister of Health of December 18, 2002 on the forms of registration notifications to the Register of Manufacturers and Medical Devices and the amount of registration fees.
- Legal Basis: Regulation of the Minister of Health of December 13, 2002 on the detailed scope of data contained in the Register of Manufacturers and Medical Devices and the Register of Medical Incidents.
- Legal Basis: Regulation of the Minister of Health of 2 December 2002 on the classification of medical devices.
- Legal Basis: Regulation of the Minister of Health of November 13, 2003, on entities authorized to issue documents constituting the basis for placing a medical device on the market and for use, and on the forms of marking with the CE conformity mark
- Legal Basis: Regulation of the Minister of Health of 15 November 2002 on the detailed requirements for reporting medical incidents and further proceedings after their reporting.
- Legal Basis: Regulation of the Minister of Health of 15 November 2002 on entities authorized to issue documents constituting the basis for introducing a medical device into circulation and use, and for marking it with a conformity mark.
- Legal Basis: Regulation of the Minister of Health of 18 July 2003 on the detailed conditions for placing on the market and use of medical devices, including in vitro diagnostic devices, intended for veterinary use
- Legal Basis: Regulation of the Minister of Health of December 20, 2002 on the forms of documents concerning clinical trials of medical devices
- Legal Basis from Art.: Regulation of the Minister of Health of 2 December 2002 on the classification of medical devices.
- Legal Basis from Art.: Regulation of the Minister of Health of 18 July 2003 on the detailed conditions for placing on the market and use of medical devices, including in vitro diagnostic devices, intended for veterinary use
- Legal Basis from Art.: Regulation of the Minister of Health of 15 November 2002 on the detailed requirements for reporting medical incidents and further proceedings after their reporting.
- Legal Basis from Art.: Regulation of the Minister of Health of December 20, 2002 on clinical trials of medical devices
- Legal Basis from Art.: Regulation of the Minister of Health of December 10, 2002 on the essential requirements for medical devices, their accessories, and the procedure for assessing the conformity of medical devices with these requirements.
- Legal Basis from Art.: Regulation of the Minister of Health of December 10, 2002 on the essential requirements for medical devices, their accessories, and the procedure for assessing the conformity of medical devices with these requirements.
- Legal Basis from Art.: Regulation of the Minister of Health of 15 November 2002 on entities authorized to issue documents constituting the basis for introducing a medical device into circulation and use, and for marking it with a conformity mark.
- Legal Basis from Art.: Regulation of the Minister of Health of December 18, 2002 on the forms of registration notifications to the Register of Manufacturers and Medical Devices and the amount of registration fees.
- Legal Basis from Art.: Regulation of the Minister of Health of November 13, 2003, on entities authorized to issue documents constituting the basis for placing a medical device on the market and for use, and on the forms of marking with the CE conformity mark
- Legal Basis from Art.: Regulation of the Minister of Health of December 13, 2002 on the detailed scope of data contained in the Register of Manufacturers and Medical Devices and the Register of Medical Incidents.
- Legal Basis from Art.: Regulation of the Minister of Health of December 20, 2002 on the forms of documents concerning clinical trials of medical devices
- Introduced Provisions: Law of September 6, 2001, Provisions introducing the Pharmaceutical Law, the Law on Medical Devices and the Law on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.