Home / Dz.U. 2004 nr 93 poz. 896
Law of 20 April 2004 on medical devices
Ustawa z dnia 20 kwietnia 2004 r. o wyrobach medycznych
Type
Law (Ustawa)
Status
repealed (uchylony)
Announced
2004-04-20
Entry into force
2004-05-01
Texts
The consolidated text (tekst ujednolicony) is unofficial; only the signed PDFs from Dziennik Ustaw / Monitor Polski are legally authentic.
Keywords
Medical Productssupervisionbezpieczeństwo produktówclassification
Related acts
Repealing Acts (1)
- Law of May 20, 2010 on medical devices · 2010-09-18
Repealed Acts (2)
- Law of July 27, 2001, on medical devices. · 2004-05-01
- Act of 30 August 2002 on amending the Act on Medical Devices. · 2004-05-01
Acts Declared Repealed (6)
- Regulation of the Minister of Health of December 20, 2002 on the forms of documents concerning clinical trials of medical devices · 2004-05-01
- Regulation of the Minister of Health of December 20, 2002 on clinical trials of medical devices · 2004-05-01
- 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 · 2004-05-01
- 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. · 2004-05-01
- Regulation of the Minister of Health of 2 December 2002 on the classification of medical devices. · 2004-05-01
- 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 · 2004-05-01
Implementing Regulations (18)
- Regulation of the Minister of Health of 3 November 2004 on the essential requirements for in vitro diagnostic medical devices
- Regulation of the Minister of Health of August 4, 2004, amending the regulation on the forms of notification for the Register of Medical Devices and entities responsible for their placing on the market and use, and the method of transmitting data covered by the notification forms
- Regulation of the Minister of Health of April 30, 2004, on the method of reporting medical incidents and further proceedings after their reporting
- Regulation of the Minister of Health of April 30, 2004, on the form of the application for a permit to commence clinical trials of a medical device, the final report on the execution of such trials, and the form of the declaration of conformity of a medical device intended for clinical trials with safety requirements
- Regulation of the Minister of Health of April 30, 2004, on the detailed requirements that entities applying for authorization for notification in the field of medical devices should meet
- Regulation of the Minister of Health of April 30, 2004 on the form of marking medical devices with the CE mark
- Regulation of the Minister of Health of April 30, 2004, on the amount of registration fees for notification to the Register of Medical Devices and entities responsible for their placing on the market and use, and for changes to data contained in the Register
- Regulation of the Minister of Health of April 30, 2004, on the forms of notification for the Register of Medical Devices and entities responsible for their placing on the market and use, and the method of transmitting data covered by the notification forms
- Regulation of the Minister of Health of April 30, 2004, on the classification of medical devices for different purposes
- Regulation of the Minister of Health of 3 November 2004 on the essential requirements for medical devices for various purposes
- Regulation of the Minister of Finance of May 27, 2010 amending the regulation on actions taken in connection with the detention of medical devices for which there are reasonable grounds to believe that they do not meet their specified requirements
- Regulation of the Minister of Finance of 21 May 2008 on actions taken in connection with the detention of medical devices for which there are reasonable grounds to believe that they do not meet their specified requirements
- Regulation of the Minister of Health of April 24, 2007 amending the regulation on the essential requirements for medical devices for different purposes
- Regulation of the Minister of Health of April 24, 2007 amending the regulation on the classification of medical devices for different purposes
- Regulation of the Minister of Health of 26 September 2005 amending the regulation on essential requirements for active implantable medical devices
- Regulation of the Minister of Health of 26 September 2005 amending the regulation on essential requirements for in vitro diagnostic medical devices
- Regulation of the Minister of Health of 26 September 2005 amending the regulation on essential requirements for medical devices for various purposes
- Regulation of the Minister of Health of 3 November 2004 on the essential requirements for active implantable medical devices
Amending Acts (4)
- Law of 27 August 2004 on healthcare benefits financed from public funds · 2004-10-01
- Law of February 17, 2005, on the informatization of activities of entities performing public tasks · 2005-07-21
- Law of 24 August 2007 on amending certain laws in connection with the membership of the Republic of Poland in the European Union · 2007-10-10
- Law of 10 July 2008 on the abolition of the Chief Inspector of Trade Inspection, amending the law on Trade Inspection and certain other laws · 2008-12-31
Amended Acts (6)
- Law of 11 May 2001 on Metrology Law. · 2004-04-01
- Law of July 27, 2001, on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. · 2004-05-01
- Law of 23 January 2003 on universal insurance in the National Health Fund · 2004-05-01
- Law of 30 August 2002 on the conformity assessment system. · 2004-05-01
- 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. · 2004-05-01
- Law of September 6, 2001, Pharmaceutical Law. · 2004-05-01
Acts referring to this act
- Repealing Acts: Law of July 27, 2001, on medical devices.
- Repealing Acts: Act of 30 August 2002 on amending the Act on Medical Devices.
- Repealed Acts: Law of May 20, 2010 on medical devices
- Amending Acts: Law of 23 January 2003 on universal insurance in the National Health Fund
- Amending Acts: Law of July 27, 2001, on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
- Amending Acts: Law of September 6, 2001, Pharmaceutical Law.
- Amending Acts: 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.
- Amending Acts: Law of 30 August 2002 on the conformity assessment system.
- Amending Acts: Law of 11 May 2001 on Metrology Law.
- Amended Acts: Law of 10 July 2008 on the abolition of the Chief Inspector of Trade Inspection, amending the law on Trade Inspection and certain other laws
- Amended Acts: Law of 24 August 2007 on amending certain laws in connection with the membership of the Republic of Poland in the European Union
- Amended Acts: Law of February 17, 2005, on the informatization of activities of entities performing public tasks
- Amended Acts: Law of 27 August 2004 on healthcare benefits financed from public funds
- References: Announcement of the President of the Polish Committee for Standardization of August 2, 2007, regarding the list of harmonized standards
- References: Announcement of the President of the Polish Committee for Standardization of January 16, 2008, concerning the list of harmonized standards
- References: Announcement of the President of the Polish Committee for Standardization of 14 June 2004 concerning the lists of harmonised standards
- References: Announcement of the President of the Polish Committee for Standardization of July 10, 2008, on the list of harmonized standards
- References: Announcement of the President of the Polish Committee for Standardization of 12 July 2005 on the list of harmonized standards
- References: Announcement of the President of the Polish Committee for Standardization of January 13, 2009, on the list of harmonized standards
- References: Announcement of the President of the Polish Committee for Standardization of 20 December 2004 concerning the lists of harmonised standards
- References: Announcement of the President of the Polish Committee for Standardization of July 13, 2009, on the list of harmonized standards
- References: Law of 20 April 2004 on veterinary medicinal products
- References: Announcement of the President of the Polish Committee for Standardization of 18 February 2010 on the list of harmonized standards
- References: Announcement of the President of the Polish Committee for Standardization of September 10, 2010, on the list of harmonized standards
- References: Announcement of the President of the Polish Committee for Standardization of 17 October 2005 on the list of harmonized standards
- References: Regulation of the Minister of Health of March 12, 2008, on the determination of detailed rules and procedures for suspending and withdrawing medicinal products and medical devices from circulation
- References: Announcement of the President of the Polish Committee for Standardization of January 9, 2006, on the list of harmonized standards
- References: Announcement of the President of the Polish Committee for Standardization of January 9, 2006, on the list of harmonized standards
- References: Law of 17 December 2009 amending the Code of Civil Procedure and certain other laws
- References: Announcement of the President of the Polish Committee for Standardization of April 11, 2006, concerning the list of harmonized standards
- References: Announcement of the President of the Polish Committee for Standardization of January 28, 2005, on the list of harmonized standards
- References: Announcement of the President of the Polish Committee for Standardization of July 11, 2006, on the list of harmonized standards
- References: Announcement of the President of the Polish Committee for Standardization of 6 October 2006 on the list of harmonized standards
- References: Law of July 16, 2004 Telecommunications Law
- References: Regulation of the Minister of Health of July 6, 2004, on technical and safety requirements for electromedical equipment used in veterinary medicine
- References: Announcement of the President of the Polish Committee for Standardization of April 12, 2005, on the lists of harmonized standards
- References: Announcement of the President of the Polish Committee for Standardization of 15 January 2007 on the list of harmonized standards
- References: Law of April 13, 2007 on electromagnetic compatibility
- References: Announcement of the President of the Polish Committee for Standardization of 15 January 2007 on the list of harmonized standards
- References: Law of 14 July 2006 on amending the Law on Healthcare Facilities and certain other laws
- Legal Basis: Regulation of the Minister of Health of April 30, 2004, on the amount of registration fees for notification to the Register of Medical Devices and entities responsible for their placing on the market and use, and for changes to data contained in the Register
- Legal Basis: Regulation of the Minister of Finance of May 27, 2010 amending the regulation on actions taken in connection with the detention of medical devices for which there are reasonable grounds to believe that they do not meet their specified requirements
- Legal Basis: Regulation of the Minister of Finance of 21 May 2008 on actions taken in connection with the detention of medical devices for which there are reasonable grounds to believe that they do not meet their specified requirements
- Legal Basis: Regulation of the Minister of Health of April 24, 2007 amending the regulation on the essential requirements for medical devices for different purposes
- Legal Basis: Regulation of the Minister of Health of April 24, 2007 amending the regulation on the classification of medical devices for different purposes
- Legal Basis: Regulation of the Minister of Health of 26 September 2005 amending the regulation on essential requirements for active implantable medical devices
- Legal Basis: Regulation of the Minister of Health of 26 September 2005 amending the regulation on essential requirements for in vitro diagnostic medical devices
- Legal Basis: Regulation of the Minister of Health of 26 September 2005 amending the regulation on essential requirements for medical devices for various purposes
- Legal Basis: Regulation of the Minister of Health of 3 November 2004 on the essential requirements for active implantable medical devices
- Legal Basis: Regulation of the Minister of Health of 3 November 2004 on the essential requirements for in vitro diagnostic medical devices