KIELTYKA GLADKOWSKI LEGAL

Medical devices including medical devices law under combined ATMPs

Advisory services for combined medical devices ATMPs is a prime example from the practice of KIELTYKA GLADKOWSKI, that we build support for foreign clients in legal aspects of medical devices based on experience on the border of modern technologies (including IT) and the most modern regulatory law.

KIELTYKA GLADKOWSKI supports foreign entities with its experience at all stages of the commercial activity of the health sector in Poland in the field of legal advisory services for foreign entities in the medical devices sector.

Our law firm operates also on current basis in the area of typical and standard regulatory issues, which include, for example:

  1. Representation of the foreign manufacturer and responsible entities in the marketing and putting into service of medical devices in Poland;
  2. Legal support for the recall of a medical device and the fulfillment of all reporting requirements on known incidents in medical procedures in which the medical device has been used;
  3. Representation of foreign clients at the so-called “Certificates of free sale”;
  4. Legal advice for the manufacturer of a medical device on the advertising of medical devices.

KIELTYKA GLADKOWSKI supports its clients also at very important stages of the production of medical devices, especially in clinical trials of medical devices. In this regard, we advise not only foreign clients and future manufacturers of medical devices. Sometimes we protect the interests of CRO entities by indicating the entire roadmap on how to legally organize the clinical trial process of medical devices, even the most modern ones.

Examples of KIELTYKA GLADKOWSKI areas of activity as part of support for foreign entities operating in Poland in the medical devices sector include:

  1. Legal assistance within incorporated medical devices to combined advanced therapy medical products (legal status of medical devices under combined ATMPs);
  2. Legal support for conformity assessment procedures for active implantable medical devices;
  3. Legal counseling in the procedure of planning and conducting clinical trials;
  4. Legal protection of the interests of a foreign sponsor at the stage of preparation of the clinical trial protocol;
  5. Legal support in respect of conformity assessment procedures for in vitro diagnostic medical devices;
  6. Recommendations and guidelines regarding medical devices for in vitro diagnostics;
  7. Post-market surveillance of medical devices;
  8. Legal counseling for suppliers of IT solutions and software in the field of medical devices;
  9. Legal support in the procedures of reporting incidents using medical devices in medical procedures;
  10. Legal assistance regarding urgent recalls of medical devices from the market; regulatory law of supervision over the sale of medical devices in Poland;
  11. The law of the regulatory status of medical products in Poland;
  12. Representation of manufacturers and responsible entities in Poland when placing a medical device on the market and putting it into service.

Legal regulatory support is not the only aspect of KIELTYKA GLADKOWSKI’s activities for the clients of the medical devices sector. We represent foreign clients in civil proceedings before Polish courts of all instances.

Who are our clients?

  • Manufacturers of medical devices;
  • Hospitals and medical entities;
  • Manufacturer of active implantable medical devices;
  • Entities operating as part of clinical evaluation conducted as part of conformity assessment for a medical device;
  • Laboratory entities cooperating with notified bodies;
  • Universities, including university units responsible for university technology transfers;
  • Brokers and intermediaries in the sale of compulsory third party liability insurance of the sponsor and clinical researcher in connection with the conduct of clinical trials of devices;
  • CRO entities in clinical trial processes of a medical device;
  • Sponsors of clinical research processes;
  • Clinical researchers of medical devices;
  • Entities that monitor the clinical trials of medical devices;

Entities in the sector of in vitro diagnostic medical devices, i.e. devices intended for testing samples taken from the human body; for example, serological diagnostic reagents, urine containers, in vitro diagnostic devices for self-monitoring, such as, e.g., pregnancy tests; manufacturers of in vitro diagnostic medical devices, including manufacturers of self-testing devices;

KIELTYKA GLADKOWSKI provides specialised legal assistance on the basis of legal sources regulating the medical devices sector in detail, which include in particular:

Polish legal regulations (harmonizing, incorporating and supplementing the legal order of the medical devices sector under European Union law):

  • Act of April 7, 2022 on medical devices (Journal of Laws, item 974);
  • Regulation of the Polish Minister of Health of 26 July 2022 on fees for medical devices (Journal of Laws, item 1582);
  • Regulation of the Polish Minister of Health of February 17, 2016 on essential requirements and conformity assessment procedures for medical devices (Journal of Laws, item 211);
  • Regulation of the Polish Minister of Health of 12 January 2011 on essential requirements and conformity assessment procedures for active implantable medical devices (consolidated text: Journal of Laws of 2017, item 311);
  • Act of 18 March 2011 on the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (consolidated text: Journal of Laws of 2020, item 836, as amended);
  • Ordinance of the Polish Minister of Health of December 29, 2021 on orders for the supply of medical devices and orders for the repair of a medical device (Journal of Laws, item 2499);
  • Act of May 20, 2010 on medical devices (Journal of Laws of 2015, item 876 as amended);
  • Ordinance of the Polish Minister of Health of February 16, 2016 on the amount of fees for submitting notifications regarding products and the amount of fees for submitting an application for a certificate of free sale (Journal of Laws of 2016, item 202);
  • Regulation of the Polish Minister of Health of 23 September 2010 on the model of the CE mark (Journal of Laws of 2010, No. 186, item 1252);
  • Ordinance of the Polish Minister of Finance of October 6, 2010 on compulsory third party liability insurance for an authorized body and a notified body (Journal of Laws of 2010, No. 194, item 1289);
  • Ordinance of the Polish Minister of Finance of October 6, 2010 on compulsory third party liability insurance for sponsors and clinical investigators in connection with the conduct of a clinical trial of devices (Journal of Laws of 2010, No. 194, item 1290);
  • Regulation of the Polish Minister of Health of 17 February 2016 on the method of submitting notifications and notifications regarding products (Journal of Laws of 2016, item 2010);
  • Regulation of the Polish Minister of Health of 5 November 2010 on the method of classifying medical devices (Journal of Laws of 2010, No. 215, item 1416);
  • Regulation of the Polish Minister of Health of February 17, 2016 on templates of applications related to the clinical examination of a medical device or active implantable medical device and the amount of fees for submitting these applications (Journal of Laws of 2016, item 208);
  • Regulation of the Polish Minister of Health of February 17, 2016 on essential requirements and conformity assessment procedures for medical devices (Journal of Laws of 2016, item 211);
  • Regulation of the Polish Minister of Health of January 12, 2011 on essential requirements and conformity assessment procedures for in vitro diagnostic medical devices (consolidated text: Journal of Laws of 2013, item 1127);
  • Regulation of the Polish Minister of Health of 17 February 2016 amending the regulation on essential requirements and conformity assessment procedures for active implantable medical devices (Journal of Laws of 2016, item 206);
  • Regulation of the Polish Minister of Health of February 16, 2016 on the criteria for reporting events with products, the method of reporting medical incidents and activities in the field of product safety (Journal of Laws of 2016, item 201);
  • Regulation of the Polish Minister of Health of February 16, 2016 on detailed requirements for planning, conducting, monitoring and documenting a clinical trial of a medical device (Journal of Laws of 2016, item 209);
  • Regulation of the Polish Minister of Health of 10 March 2011 on the detailed conditions to be met by clinical evaluation of medical devices or active implantable medical devices (Journal of Laws of 2011, No. 63, item 331);
  • Regulation of the Polish Minister of Health of February 16, 2016 on granting authorizations to units for the purpose of their notification in the field of products, the amount of fees for submitting applications in this regard and conducting inspections of units applying for authorization and notified bodies (Journal of Laws of 2016, item 204);

European Union Regulations:

  • Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Journal of Laws of the European Union of 2017 No. 117, p. 1, as amended);
  • Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Journal of Laws L 117, 5.5.2017) (Journal of Laws EU. No. 2021, No. 241, p. 7);
  • Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of some of its provisions (Journal of Laws EU. L. of 2020, No. 130, p. 18);
  • Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017) (Journal of Laws of the EU. No. of 2019, No. 334, p. 165);
  • Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Journal of Laws L 117, 5.5.2017) (Journal of Laws EU. L. of 2019 No. 117, p. 9);
  • Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Journal of Laws EU. L. of 2017, No. 117, p. 176, as amended);
  • Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council (OJ EU L. of 2022, No. 178, p. 3);
  • Commission Implementing Regulation (EU) 2022/945 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the fees that may be charged by EU reference laboratories in the field of in vitro diagnostic medical devices (Journal of Laws EU. No. of 2022 No. 164, p. 20);
  • Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ EU L. of 2007, No. 324, p. 121, as amended);
  • Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks and criteria to be met by European Union reference laboratories in the field of medical devices for in vitro diagnostics (Journal of Laws EU. No. of 2022, No. 164, p. 7);
  • Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for assigning Unique Device Identification Codes (“UDI”) in the field of medical devices (Journal of Laws of the EU, 2019, no. No. 149, p. 73);
  • Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and the corresponding device types to clarify the scope of the designation of notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (Journal of Laws EU. No. of 2017, No. 309, p. 7);
  • Council Directive 90/385/EEC of June 20, 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (Journal of Laws EC L 189 of July 20, 1990, p. 17; special edition, chapter 13, vol. 10, p. 154);
  • Council Directive 93/42/EEC of June 14, 1993 on medical devices (Journal of Laws EC L 169 of July 12, 1993, p. 1);
  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices;
  • Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast prostheses within the framework of Directive 93/42/EEC relating to medical devices (OJ L 28 of 04.02.2003, p. 43);
  • Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder prostheses under Council Directive 93/42/EEC on medical devices (OJ L 210 of 12.08.2005, p. 41);
  • Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices (Journal of Laws UE L 131 of 16.05.2002, p. 17, as amended);
  • Commission Decision No. 2010/227/EU of 19 April 2010 on the European database on medical devices (Eudamed) (Journal of Laws EU L 102 of 23 April 2010, p. 45);
  • Commission Regulation (EU) No. 207/2012 of March 9, 2012 on electronic instructions for use of medical devices (Journal of Laws EU L 72 of March 10, 2012, p. 28);
  • Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning specific requirements relating to the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC for active implantable medical devices and medical devices manufactured with the use of tissues of animal origin (Journal of Laws EU L 212 of 09.08.2012, p. 3);
  • Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (Journal of Laws EU L 253 of 25.09.2013, p. 8);
  • Commission Recommendation 2013/172/EU of 5 April 2013 on a common framework for the system of unique identification codes for medical devices in the Union (OJ L 99 of 09.04.2013, p. 17);
  • Commission Recommendation 2013/473/EU of September 24, 2013 on audits and assessments carried out by notified bodies in the field of medical devices (Journal of Laws EU L 253 of September 25, 2013, p. 27);
  • Commission communication in the framework of the implementation of the Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) (OJ EU C 173 of 13.05.2016, p. 92);
  • Commission communication in the framework of the implementation of the Council Directive of 14 June 1993 on medical devices (93/42/EEC) (OJ EU C 173 of 13.05.2016, p. 100);
  • Communication from the Commission in the framework of the implementation of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Official Journal EU C 173 of 13.05.2016, p. 136).
UP