Home / Dz.U. 2022 poz. 974
Law of April 7, 2022, on medical devices
Ustawa z dnia 7 kwietnia 2022 r. o wyrobach medycznych
Type
Law (Ustawa)
Status
act has a consolidated text (akt posiada tekst jednolity)
Announced
2022-04-07
Entry into force
2022-05-26
Texts
The consolidated text (tekst ujednolicony) is unofficial; only the signed PDFs from Dziennik Ustaw / Monitor Polski are legally authentic.
Keywords
research and certificationsciencelaboratory diagnosticsPharmacistschoroby zakaźneMedicines and Sanitary Articleshealth protectionadministrative proceedingsPharmaceutical Lawmedical registersmedical benefitspatientssupervisionDentistsmedical activitiesadvertisingatomic lawproductsBlood donationgoodsassaying lawFeldshersDoctorsMedical Productsnational defenceopinionsprofessional soldiermedical commissionsinspectioncode of civil proceduretax on goods and servicessalemental health protectionenterprisesTax Ordinanceelectronic devicesprocedurepecuniary and disciplinary penaltieshealthcareinformation and communication technology systems
Related acts
Repealed Acts (2)
Acts Declared Repealed (16)
- 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 · 2022-05-26
- 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 · 2022-05-26
- Regulation of the Minister of Finance of October 6, 2010, on mandatory civil liability insurance of an authorized entity and a notified entity · 2022-05-26
- Regulation of the Minister of Health of September 23, 2010, on the design of the CE mark · 2022-05-26
- Regulation of the Minister of Health of November 3, 2020, amending the regulation concerning the manner of submitting notifications and communications regarding products · 2022-05-26
- Regulation of the Minister of Health of 17 February 2016 on the manner of making notifications and communications concerning devices · 2022-05-26
- 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 · 2022-05-26
- 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 · 2022-05-26
- 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 · 2022-11-27
- 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 · 2030-05-26
- Regulation of the Minister of Health of January 12, 2011, on the essential requirements and conformity assessment procedures for active implantable medical devices · 2040-05-26
- 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 · 2040-05-26
- Regulation of the Minister of Health of January 12, 2011, on the essential requirements and conformity assessment procedures for in vitro diagnostic medical devices · 2040-05-26
- Regulation of the Minister of Health of November 5, 2010, on the classification of medical devices · 2040-05-26
- Regulation of the Minister of Health of February 17, 2016, on the essential requirements and conformity assessment procedures for medical devices · 2040-05-26
- 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 · 2040-05-26
Implementing Regulations (4)
- Regulation of the Minister of Finance of December 2, 2022 on mandatory insurance of the sponsor and researcher in connection with conducting a clinical trial of a device or a performance study of an in vitro diagnostic medical device
- Regulation of the Minister of Health of July 26, 2022, on fees related to medical devices.
- Regulation of the Minister of Health of April 21, 2023, on the advertising of medical devices
- Regulation of the Minister of Health of December 12, 2022 on the form of the serious incident notification form
Amending Acts (2)
Amended Acts (32)
- Law of September 6, 2001, Pharmaceutical Law. · 2022-05-26
- Law of July 27, 2001, on laboratory diagnostics. · 2022-05-26
- Law of August 29, 1997 - Tax Ordinance. · 2022-05-26
- Law of 22 August 1997 on the Public Blood Service. · 2022-05-26
- Law of 5 December 1996 on the professions of physician and dentist. · 2022-05-26
- Law of 19 August 1994 on mental health protection · 2022-05-26
- Law of 17 November 1964 - Code of Civil Procedure. · 2022-05-26
- Law of 20 July 1950 on the profession of feldsher. · 2022-05-26
- Law of 11 March 2004 on value added tax · 2022-05-26
- Law of March 11, 2022, on Homeland Defence · 2022-05-26
- Law of December 10, 2020, on the profession of a pharmacist · 2022-05-26
- Law of 6 March 2018 - Entrepreneurs' Law · 2022-05-26
- Law of April 13, 2016, on conformity assessment and market surveillance systems · 2022-05-26
- Law of 11 September 2015 on public health · 2022-05-26
- Law of September 11, 2015, on waste electrical and electronic equipment · 2022-05-26
- Law of November 22, 2013, on proceedings concerning persons with mental disorders posing a threat to the life, health or sexual freedom of others · 2022-05-26
- Law of May 12, 2011, on the reimbursement of medicines, foodstuffs for special medical purposes, and medical devices · 2022-05-26
- Law of April 28, 2011, on the health protection information system · 2022-05-26
- Law of April 15, 2011, on healthcare activities · 2022-05-26
- Law of 1 April 2011 on Hallmarking · 2022-05-26
- Law of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products · 2022-05-26
- Law of 7 May 2009 on packaged goods · 2022-05-26
- Law of 6 November 2008 on Health Care Consultants · 2022-05-26
- Law of November 6, 2008, on Patient Rights and the Patient Ombudsman · 2022-05-26
- Law of December 5, 2008, on the prevention and combating of infections and infectious diseases in humans · 2022-05-26
- Law of April 13, 2007 on electromagnetic compatibility · 2022-05-26
- Law of 8 September 2006 on State Medical Rescue · 2022-05-26
- Law of January 29, 2004, on the Veterinary Inspectorate · 2022-05-26
- Law of 27 August 2004 on healthcare benefits financed from public funds · 2022-05-26
- Law of 11 September 2003 on the military service of professional soldiers · 2022-05-26
- … +2
Acts referring to this act
- Repealing Acts: 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
- Repealing Acts: Law of May 20, 2010 on medical devices
- Amending Acts: Law of November 6, 2008, on Patient Rights and the Patient Ombudsman
- Amending Acts: Law of 30 August 2002 on the conformity assessment system.
- Amending Acts: Law of 11 September 2003 on the military service of professional soldiers
- Amending Acts: Law of January 29, 2004, on the Veterinary Inspectorate
- Amending Acts: Law of 11 March 2004 on value added tax
- 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 April 13, 2007 on electromagnetic compatibility
- Amending Acts: Law of 7 May 2009 on packaged goods
- Amending Acts: Law of 6 November 2008 on Health Care Consultants
- Amending Acts: Law of December 5, 2008, on the prevention and combating of infections and infectious diseases in humans
- Amending Acts: Law of March 11, 2022, on Homeland Defence
- Amending Acts: Law of December 10, 2020, on the profession of a pharmacist
- Amending Acts: Law of 20 July 1950 on the profession of feldsher.
- Amending Acts: Law of 6 March 2018 - Entrepreneurs' Law
- Amending Acts: Law of April 13, 2016, on conformity assessment and market surveillance systems
- Amending Acts: Law of 17 November 1964 - Code of Civil Procedure.
- Amending Acts: Law of 19 August 1994 on mental health protection
- Amending Acts: Law of 5 December 1996 on the professions of physician and dentist.
- Amending Acts: Law of 22 August 1997 on the Public Blood Service.
- Amending Acts: Law of August 29, 1997 - Tax Ordinance.
- Amending Acts: Law of November 29, 2000 Atomic Law.
- Amending Acts: Law of July 27, 2001, on laboratory diagnostics.
- Amending Acts: Law of 11 September 2015 on public health
- Amending Acts: Law of September 11, 2015, on waste electrical and electronic equipment
- Amending Acts: Law of November 22, 2013, on proceedings concerning persons with mental disorders posing a threat to the life, health or sexual freedom of others
- Amending Acts: Law of September 6, 2001, Pharmaceutical Law.
- Amending Acts: Law of May 12, 2011, on the reimbursement of medicines, foodstuffs for special medical purposes, and medical devices
- Amending Acts: Law of April 28, 2011, on the health protection information system
- Amending Acts: Law of April 15, 2011, on healthcare activities
- Amending Acts: Law of 1 April 2011 on Hallmarking
- Amending Acts: Law of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Amended Acts: Law of July 12, 2024 - Provisions introducing the law - Electronic Communications Law
- Amended Acts: Law of 17 August 2023 on amending the Law on the reimbursement of medicines, foodstuffs for special medical purposes and medical devices, and certain other laws
- Legal Basis: Regulation of the Minister of Health of April 21, 2023, on the advertising of medical devices
- Legal Basis: Regulation of the Minister of Health of December 12, 2022 on the form of the serious incident notification form
- Legal Basis: Regulation of the Minister of Health of July 26, 2022, on fees related to medical devices.
- Legal Basis: Regulation of the Minister of Finance of December 2, 2022 on mandatory insurance of the sponsor and researcher in connection with conducting a clinical trial of a device or a performance study of an in vitro diagnostic medical device
- Legal Basis from Art.: Regulation of the Minister of Health of April 21, 2023, on the advertising of medical devices
- Legal Basis from Art.: Regulation of the Minister of Health of July 26, 2022, on fees related to medical devices.
- Legal Basis from Art.: Regulation of the Minister of Health of December 12, 2022 on the form of the serious incident notification form
- Legal Basis from Art.: Regulation of the Minister of Finance of December 2, 2022 on mandatory insurance of the sponsor and researcher in connection with conducting a clinical trial of a device or a performance study of an in vitro diagnostic medical device
- Consolidated Text for an Act: Announcement of the Marshal of the Sejm of the Republic of Poland of October 10, 2024, on the announcement of the consolidated text of the law on medical devices
- Repeals Resulting From: 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
- Repeals Resulting From: Regulation of the Minister of Health of February 17, 2016, on the essential requirements and conformity assessment procedures for medical devices
- Repeals Resulting From: 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
- Repeals Resulting From: Regulation of the Minister of Health of November 5, 2010, on the classification of medical devices
- Repeals Resulting From: Regulation of the Minister of Health of January 12, 2011, on the essential requirements and conformity assessment procedures for in vitro diagnostic medical devices