Home / Dz.U. 2010 nr 107 poz. 679
Law of May 20, 2010 on medical devices
Ustawa z dnia 20 maja 2010 r. o wyrobach medycznych
Type
Law (Ustawa)
Status
repealed (uchylony)
Announced
2010-05-20
Entry into force
2010-09-18
Texts
The consolidated text (tekst ujednolicony) is unofficial; only the signed PDFs from Dziennik Ustaw / Monitor Polski are legally authentic.
Keywords
product qualitypackagingresearch and certificationMedical Productssupervisionbezpieczeństwo produktówhealth protection
Related acts
Repealing Acts (1)
- Law of April 7, 2022, on medical devices · 2022-05-26
Repealed Acts (1)
- Law of 20 April 2004 on medical devices · 2010-09-18
Acts Declared Repealed (20)
- Regulation of the Minister of Health of 26 September 2005 amending the regulation on essential requirements for active implantable medical devices · 2010-09-18
- Regulation of the Minister of Health of 26 September 2005 amending the regulation on essential requirements for in vitro diagnostic medical devices · 2010-09-18
- Regulation of the Minister of Health of 26 September 2005 amending the regulation on essential requirements for medical devices for various purposes · 2010-09-18
- Regulation of the Minister of Health of 3 November 2004 on the essential requirements for active implantable medical devices · 2010-09-18
- Regulation of the Minister of Health of 3 November 2004 on the essential requirements for in vitro diagnostic medical devices · 2010-09-18
- Regulation of the Minister of Health of 3 November 2004 on the essential requirements for medical devices for various purposes · 2010-09-18
- 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 · 2010-09-18
- Regulation of the Minister of Health of April 30, 2004, on the method of reporting medical incidents and further proceedings after their reporting · 2010-09-18
- Regulation of the Minister of Health of April 24, 2007 amending the regulation on the essential requirements for medical devices for different purposes · 2010-09-18
- 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 · 2010-09-18
- Regulation of the Minister of Health of April 30, 2004 on the form of marking medical devices with the CE mark · 2010-09-18
- 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 · 2010-09-18
- 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 · 2010-09-18
- Regulation of the Minister of Health of April 30, 2004, on the classification of medical devices for different purposes · 2010-09-18
- 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 · 2010-09-18
- 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 · 2010-09-18
- 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 · 2010-09-18
- Regulation of the Minister of Health of April 24, 2007 amending the regulation on the classification of medical devices for different purposes · 2010-09-18
- Regulation of the Minister of National Defence of April 27, 2007 amending the regulation on the list of medicinal products marked with the OTC symbol and medical devices issued free of charge · 2011-03-22
- Regulation of the Minister of National Defence of March 23, 2005, on the list of medicinal products marked with the OTC symbol and medical devices issued free of charge · 2011-03-22
Implementing Regulations (26)
- Regulation of the Minister of Health of 18 October 2010 on the method of making notifications and reports concerning medicinal products
- Regulation of the Minister of Finance of October 6, 2010, on mandatory civil liability insurance of the sponsor and clinical investigator in connection with conducting clinical trials of medical devices
- Regulation of the Minister of Finance of October 6, 2010, on mandatory civil liability insurance of an authorized entity and a notified entity
- Regulation of the Minister of Health of September 23, 2010, on the design of the CE mark
- Regulation of the Minister of Health of September 22, 2010, on the amount of fees for notifications and communications regarding products and the amount of the fee for submitting an application for a free sale certificate
- Regulation of the Minister of Health of November 3, 2020, amending the regulation concerning the manner of submitting notifications and communications regarding products
- Regulation of the Minister of Health of February 17, 2016, on the essential requirements and conformity assessment procedures for medical devices
- Regulation of the Minister of Health of 17 February 2016 on the manner of making notifications and communications concerning devices
- Regulation of the Minister of Health of February 16, 2016, on the detailed requirements for planning, conducting, monitoring, and documenting clinical investigations of medical devices
- Regulation of the Minister of Health of 17 February 2016 on the forms of applications related to clinical trials of medical devices or active implantable medical devices and the fees for submitting these applications
- Regulation of the Minister of Health of February 17, 2016, amending the regulation on the essential requirements and conformity assessment procedures for active implantable medical devices
- Regulation of the Minister of Health of February 16, 2016, on granting authorization to entities for their notification in the scope of devices, the amount of fees for submitting applications in this scope, and conducting control of entities applying for authorization and notified entities
- Regulation of the Minister of Health of February 16, 2016, on the amount of fees for submitting notifications regarding devices and the amount of the fee for submitting an application for a free sale certificate
- Regulation of the Minister of Health of February 16, 2016, on the criteria for reporting events with devices, the method of reporting medical incidents and device safety actions
- Regulation of the Minister of Health of October 17, 2014, amending the regulation on the method of making notifications and reports concerning medical devices
- Regulation of the Minister of Health of April 10, 2012, amending the regulation on essential requirements and conformity assessment procedures for in vitro diagnostic medical devices
- Regulation of the Minister of Health of January 12, 2011, on the essential requirements and conformity assessment procedures for active implantable medical devices
- Regulation of the Minister of Health of January 12, 2011, on the essential requirements and conformity assessment procedures for in vitro diagnostic medical devices
- Regulation of the Minister of Health of January 12, 2011, on essential requirements and conformity assessment procedures for medical devices
- Regulation of the Minister of Health of March 31, 2011, on the detailed requirements that entities applying for authorization for notification in the field of products should meet, and the manner of supervision and control of notified entities
- Regulation of the Minister of Health of 10 March 2011 on the detailed conditions that the clinical evaluation of medical devices or active implantable medical devices should meet
- Regulation of the Minister of Health of February 11, 2011 on requirements concerning the handling of essential clinical trial documentation
- Regulation of the Minister of Health of February 2, 2011 on criteria for reporting incidents with medical devices, the method of reporting medical incidents and device safety measures
- Regulation of the Minister of Health of 28 October 2011 amending the regulation on the amount of fees for notifications and announcements regarding medical devices and the amount of the fee for submitting an application for a free sale certificate
- Regulation of the Minister of Health of 15 November 2010 on the forms of applications submitted in connection with a clinical trial, the amount of fees for submitting applications, and the final report on the conduct of a clinical trial
- Regulation of the Minister of Health of November 5, 2010, on the classification of medical devices
Amending Acts (14)
- Law of 15 April 2011 amending the conformity assessment system law and certain other laws · 2011-11-19
- Law of April 28, 2011, on the health protection information system · 2012-01-01
- Law of 22 July 2014 amending the law on healthcare benefits financed from public funds and certain other laws · 2015-01-01
- Law of 7 November 2014 on facilitating business activities · 2015-01-01
- Law of 11 September 2015 on amending the law on medical devices and certain other laws · 2016-02-20
- Law of April 13, 2016, on conformity assessment and market surveillance systems · 2016-04-20
- Law of 22 June 2016 amending the Law - Customs Law and certain other laws · 2016-08-20
- Law of 5 September 2016 on trust services and electronic identification · 2016-10-07
- Law of November 16, 2016, - Provisions introducing the Law on the National Revenue Administration · 2017-03-01
- Law of 6 March 2018 - Provisions introducing the Law - Entrepreneurs' Law and other laws concerning economic activity · 2018-04-30
- Law of 21 February 2019 on the Medical Research Agency · 2019-03-22
- Law of February 21, 2019 on the Łukasiewicz Research Network · 2019-04-01
- Law of 14 August 2020 amending certain laws to ensure the functioning of healthcare in connection with the COVID-19 epidemic and after its cessation · 2020-09-01
- Law of December 17, 2020, on strategic reserves · 2021-02-23
Amended Acts (28)
- Law of January 11, 2001, on chemical substances and preparations. · 2010-09-18
- Law of 11 May 2001 on Metrology Law. · 2010-09-18
- Law of March 30, 2001 on cosmetics. · 2010-09-18
- Law of November 29, 2000 Atomic Law. · 2010-09-18
- Law of September 6, 2001, Pharmaceutical Law. · 2010-09-18
- Law of July 27, 2001, on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. · 2010-09-18
- Law of September 4, 1997, on government administration departments. · 2010-09-18
- Law of 5 December 1996 on the professions of physician and dentist. · 2010-09-18
- Law of May 30, 1996, on state reserves and mandatory fuel stocks. · 2010-09-18
- Law of 19 August 1994 on mental health protection · 2010-09-18
- Law of April 3, 1993, on Assay. · 2010-09-18
- Law of August 30, 1991, on healthcare facilities. · 2010-09-18
- Law of April 19, 1991, on Pharmaceutical Chambers. · 2010-09-18
- Law of November 21, 1967, on the universal obligation to defend the Republic of Poland. · 2010-09-18
- Law of 20 July 1950 on the profession of feldsher. · 2010-09-18
- Law of July 5, 2001, on prices. · 2010-09-18
- Law of 7 May 2009 on packaged goods · 2010-09-18
- Law of 6 November 2008 on Health Care Consultants · 2010-09-18
- Law of December 5, 2008, on the prevention and combating of infections and infectious diseases in humans · 2010-09-18
- Law of April 13, 2007 on electromagnetic compatibility · 2010-09-18
- Law of November 16, 2006, on stamp duty · 2010-09-18
- Law of 8 September 2006 on State Medical Rescue · 2010-09-18
- Law of 11 March 2004 on value added tax · 2010-09-18
- Law of 27 August 2004 on healthcare benefits financed from public funds · 2010-09-18
- Law of July 2, 2004 on freedom of economic activity · 2010-09-18
- Law of 11 September 2003 on the military service of professional soldiers · 2010-09-18
- Act of September 13, 2002 on biocidal products. · 2010-09-18
- Law of 30 August 2002 on the conformity assessment system. · 2010-09-18
Information on Consolidated Text (5)
- Announcement of the Marshal of the Sejm of the Republic of Poland of July 21, 2021, on the announcement of the consolidated text of the law on medical devices
- Announcement of the Marshal of the Sejm of the Republic of Poland of December 13, 2019, on the promulgation of the consolidated text of the law on medical devices
- Announcement of the Marshal of the Sejm of the Republic of Poland of 13 December 2018 on the promulgation of the consolidated text of the Act on medical devices
- Announcement of the Marshal of the Sejm of the Republic of Poland of January 17, 2017, on the announcement of the consolidated text of the Act on medical devices
- Announcement by the Marshal of the Sejm of the Republic of Poland of May 26, 2015, concerning the promulgation of the consolidated text of the law on medical devices
References (4)
Acts referring to this act
- Repealing Acts: Law of 20 April 2004 on medical devices
- Repealed Acts: Law of April 7, 2022, on medical devices
- Amending Acts: Law of 6 November 2008 on Health Care Consultants
- Amending Acts: Law of 7 May 2009 on packaged goods
- Amending Acts: Law of April 3, 1993, on Assay.
- Amending Acts: Law of August 30, 1991, on healthcare facilities.
- Amending Acts: Law of April 13, 2007 on electromagnetic compatibility
- Amending Acts: Law of 11 May 2001 on Metrology Law.
- Amending Acts: Law of July 5, 2001, on prices.
- Amending Acts: Law of September 6, 2001, Pharmaceutical Law.
- Amending Acts: Law of 30 August 2002 on the conformity assessment system.
- Amending Acts: Act of September 13, 2002 on biocidal products.
- Amending Acts: Law of 11 September 2003 on the military service of professional soldiers
- Amending Acts: Law of 11 March 2004 on value added tax
- Amending Acts: Law of July 2, 2004 on freedom of economic activity
- Amending Acts: Law of November 21, 1967, on the universal obligation to defend the Republic of Poland.
- Amending Acts: Law of 27 August 2004 on healthcare benefits financed from public funds
- Amending Acts: Law of 8 September 2006 on State Medical Rescue
- Amending Acts: Law of November 16, 2006, on stamp duty
- Amending Acts: Law of April 19, 1991, on Pharmaceutical Chambers.
- Amending Acts: Law of 19 August 1994 on mental health protection
- Amending Acts: Law of 20 July 1950 on the profession of feldsher.
- Amending Acts: Law of May 30, 1996, on state reserves and mandatory fuel stocks.
- Amending Acts: Law of 5 December 1996 on the professions of physician and dentist.
- Amending Acts: Law of September 4, 1997, on government administration departments.
- Amending Acts: Law of November 29, 2000 Atomic Law.
- Amending Acts: Law of January 11, 2001, on chemical substances and preparations.
- Amending Acts: Law of March 30, 2001 on cosmetics.
- Amending Acts: Law of July 27, 2001, on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
- Amending Acts: Law of December 5, 2008, on the prevention and combating of infections and infectious diseases in humans
- Amended Acts: Law of December 17, 2020, on strategic reserves
- Amended Acts: Law of 14 August 2020 amending certain laws to ensure the functioning of healthcare in connection with the COVID-19 epidemic and after its cessation
- Amended Acts: Law of February 21, 2019 on the Łukasiewicz Research Network
- Amended Acts: Law of 21 February 2019 on the Medical Research Agency
- Amended Acts: Law of 6 March 2018 - Provisions introducing the Law - Entrepreneurs' Law and other laws concerning economic activity
- Amended Acts: Law of November 16, 2016, - Provisions introducing the Law on the National Revenue Administration
- Amended Acts: Law of 5 September 2016 on trust services and electronic identification
- Amended Acts: Law of 22 June 2016 amending the Law - Customs Law and certain other laws
- Amended Acts: Law of April 13, 2016, on conformity assessment and market surveillance systems
- Amended Acts: Law of 11 September 2015 on amending the law on medical devices and certain other laws
- Amended Acts: Law of 7 November 2014 on facilitating business activities
- Amended Acts: Law of 22 July 2014 amending the law on healthcare benefits financed from public funds and certain other laws
- Amended Acts: Law of April 28, 2011, on the health protection information system
- Amended Acts: Law of 15 April 2011 amending the conformity assessment system law and certain other laws
- References: Regulation of the Council of Ministers of 25 August 2015 on the reorganisation of the Institute of Rheumatology named after Prof. Dr. Hab. Med. Eleonora Reicher in Warsaw
- References: Regulation of the Minister of Finance of July 7, 2016, amending the regulation on the delivery document, conditions, and method of returning excise goods exempt from excise duty due to their intended use, and ethyl alcohol denaturants
- References: Law of May 20, 2016, on amending the Law on the Public Blood Service and certain other laws
- References: Law of September 11, 2015, on waste electrical and electronic equipment
- References: Law of April 24, 2014, on amending the law on the universal obligation to defend the Republic of Poland and certain other laws
- References: Law of November 22, 2013, on proceedings concerning persons with mental disorders posing a threat to the life, health or sexual freedom of others