Medical devices

We provide legal advice in the following areas:

  • Applications and notifications of regulatory authorities
  • Clinical trials of medical devices
  • Manufacturing, imports and distribution of medical devices
  • Advertising of medical devices
  • Compliance
  • Medical device incidents
  • Administrative proceedings before administrative courts
  • Advice based on codes of good practice
English

The Kieszkowska Rutkowska Kolasiński law firm was established by recognised experts in pharmaceutical and medical law - Paulina Kieszkowska-Knapik, Advocate, Ewa Rutkowska, Advocate, and competition law - Marcin Kolasiński,  Legal Advisor. The law firm comprises an experienced team, which has worked with the founders for a long time.

We all have many years of experience of working in international law firms (including Baker & McKenzie, Hogan Lovells and CMS Cameron McKenna).

We have been regularly recommended as leading lawyers in pharmaceutical law and competition law by Polish and international rankings of law firms and lawyers, such as Chambers Europe, Legal 500 and Rzeczpospolita. The Chambers Europe 2014, 2015 ranking acknowledged our law firm as the best Life Sciences practice in Poland.

  • FIRM RANKINGS
    • Chambers Europe 2016
       

      Life Sciences – Band 1

      "Distinguished and specialised boutique law firm acting for established clients in the pharmaceutical, medical, food and cosmetics sectors. As well as regulatory issues, it advises on issues within competition law and legal aspects of business-to-consumer relations and public procurement. Also experienced in product liability and product safety issues". 

      "This team has very in-depth knowledge of the pharmaceutical industry. The lawyers are the number one specialists and are very responsive and pragmatic."

      "The lawyers are very good: they are very flexible and very responsive."

       

      Competition/Antitrust – Band 3

      "Recently established Warsaw-based competition boutique joins the rankings as a result of strong recognition for its competition and antitrust expertise. Advises on merger control, regulatory and compliance issues. Notably popular amongst pharmaceutical clients, but also advises companies from the energy and media industries".

      "I'm very satisfied with this team. The lawyers are very responsive, constructive and focused on finding solutions." 

      "The lawyers are able to objectively evaluate risks and losses. The team is receptive to our needs and operates very quickly."

    • Rzeczpospolita Ranking Kancelarii Prawniczych 2016
      KRK Kieszkowska Rutkowska Kolasiński – for the second time Leader in Life Sciences.

       

    • The Legal 500 Europe, Middle East and Africa 2016
      Competition/Antitrust oraz Dispute Resolution -  KRK Kieszkowska Rutkowska Kolasiński recommended.

    • Polityka Insight 2015 – Life Scienses – KRK Kieszkowska Rutkowska Kolasiński  – Group 1

    • LMG Life Sciences Awards 2015
      KRK Kieszkowska Rutkowska Kolasiński – Law firm of the year – Poland.

    • Chambers Europe 2015 Life Sciences – Band 1

      "Market-leading boutique well known for its expert knowledge of pharmaceutical law. Assists international pharmaceutical clients with contentious and advisory matters, including reimbursement, public procurement, regulatory advice, distribution and marketing. Provides additional expertise in competition law and product liability litigation."

      "It's leading the market in the area of reimbursement."

      "The lawyers really care for the client and have huge knowledge."

      "We use the firm for difficult and strategic matters."

       

    • Chambers Europe 2014 Life Sciences – Band 1

      "Market leading life sciences practice highly reputed for pharmaceutical knowhow. Singled out for regulatory work and additionally focused on the medical, food and cosmetics industries.

      Paulina Kieszkowska-Knapik and Ewa Rutkowska recently left Baker & McKenzie with Marcin Kolasiński to set up a regulatory and competition spin-off, Kieszkowska Rutkowska Kolasiński. They were joined by other colleagues including Natalia Łojko."

  • INDIVIDUAL RANKINGS
    • Paulina Kieszkowska-Knapik

      English

      Puls Medycyny List of the Hundred Most Influential People in Healthcare 2016

      Paulina Kieszkowska-Knapik – 45th on the Puls Medycyny List of the Hundred Most Influential People in Healthcare, 2016, which has been published annually for over 10 years.

      Rzeczpospolita Ranking Kancelarii Prawniczych 2016

      Paulina Kieszkowska - Knapik is the leader in this ranking for the 10th time in Pharmaceutical Law.

      Chambers Europe 2016: Star individual

      A formidable figure who stands out as a leader in the market, Paulina Kieszkowska-Knapik earns the admiration of her clients: She's a star, the queen of pharmaceutical law in Poland. She has acted for businesses and industry organisations for many years, advising on issues of pharmaceutical and healthcare protection laws, the Reimbursement Act and the Act on Medical Activity. She also provides pro bono advice for patient organisations.

      Who’sWho Legal 2016-2015 (Life Science) - Paulina Kieszkowska-Knapik recommended.

      Chambers Europe 2015 Life Sciences - Star Individuals 

      "Revered by practitioners and clients alike, Paulina Kieszkowska-Knapik is considered a star pharmaceutical lawyer. Clients appreciate her quick advice, saying: "She is very passionate about what she is doing" and "always fights to the end." She is renowned for her knowledge of reimbursement and the healthcare system."

      Chambers Europe 2014 Life Sciences: Star Individuals

      "Paulina Kieszkowska-Knapik is an acknowledged authority in the sector, particularly for pharmaceutical and healthcare law. One client notes: "She has very deep knowledge and is one of the most experienced lawyers in the market.""

      Chambers Europe 2013 Life Sciences: Star Individuals

      "Paulina Kieszkowska-Knapik is "knowledgeable and passionate. Her power is in her expertise – there is nobody out there who understands these matters like she does." She has broad experience of working with all major life sciences companies and institutions in Poland."

      Dziennik Gazeta Prawna Top 50 Most Influential Lawyers Ranking

      Paulina Kieszkowska-Knapik (position 37: 2013) – (…), co-founder of Lege Pharmaciae foundation, rise from position number 39 (2012).

      One of the most consistent and militant critics of the Reimbursement Act. Author and co-author of numerous pharmaceutical analyses. Thanks to her personal involvement, last year PricewaterhouseCoopers and IMS Health - a provider of insights into the pharmaceutical market, prepared two large reports summarising the effects of the Reimbursement Act. Her legal opinions have a large impact on the amendment of defective healthcare regulations. She was the first to raise the alarm about the adverse effects on patients welfare of the regulations of the Reimbursement Law which banned pharmaceutical companies from donating medicines to hospitals. Last year, the Ministry of Health amended the regulations at issue, and hospital donations were again permitted. Her major success was also bringing about the resolution of the eight-year long court battle to recognise that innovative, research-based producers have a legal standing in assessments of the legality of copies of their pharmaceutical products. As a member of the Batory Foundations Civic Forum on Legislation, Mrs Kieszkowska-Knapik fights for the introduction of European law-making standards in Poland. She enjoys voluntary work. She advises patientsorganisations pro bono, including the Polish Coalition of Oncological Patients Organisations, the Rak’n’Roll Foundation and the Polish Patients' Federation.

      Chambers Europe 2012 Life Sciences: Band 1

      "Paulina Kieszkowska-Knapik is singled out for her "in-depth and client-friendly approach." "I admire her brilliance and business understanding," another source adds. She co-heads the department, focusing on regulatory, competition pricing and reimbursement matters."

      PLC Which Lawyer 2012

      Life sciences: regulatory – Paulina Kieszkowska-Knapik recommended

      Life sciences: competition/anti-trust - Paulina Kieszkowska-Knapik recommended

      Intellectual Property - Paulina Kieszkowska-Knapik recommended

      Chambers Europe 2011 Life Sciences: Band 1

      "Paulina Kieszkowska-Knapik is unequivocally regarded as one of the best advisers in the field and is lauded for her "vast knowledge, excellent expertise and agile mind."”

      PLC Which Lawyer 2011

      Life sciences – overview – Paulina Kieszkowska-Knapik recommended

      Life sciences: regulatory – Paulina Kieszkowska-Knapik recommended

      Life sciences: competition/anti-trust - Paulina Kieszkowska-Knapik recommended

      Chambers Europe 2010 Life Sciences: Band 1

      "Interviewees agree that Paulina Kieszkowska-Knapik is one of the market's standout lawyers: "She is extremely knowledgeable in regulatory aspects, widely respected and straightforward with her proposals.""

      PLC Which Lawyer 2010

      Life sciences: regulatory – Paulina Kieszkowska-Knapik recommended

      Intellectual Property - Paulina Kieszkowska-Knapik recommended

      Chambers Europe 2009 Life Sciences: Band 2

      "Paulina Kieszkowska-Knapik is well known for taking a global view on cases; clients marvel at her ability to offer a business solution in addition to legal analysis.

      PLC Which Lawyer 2008

      Life sciences – Paulina Kieszkowska-Knapik recommended

      Intellectual Property - Paulina Kieszkowska-Knapik recommended

      Chambers Europe 2008 Band 1

      Paulina Kieszkowska-Knapik - Life Sciences.

      Chambers Europe 2007 Band 1

      Paulina Kieszkowska-Knapik - Life Sciences.

    • Ewa Rutkowska

      English

      Rzeczpospolita Ranking Kancelarii Prawniczych 2016

      Ewa Rutkowska is the leader in this ranking for the 8th time in Pharmaceutical Law.

      Chambers Europe 2016 Life Sciences - Band 1

      Ewa Rutkowska is a renowned expert who focuses on pharmaceutical, healthcare and product liability laws, with extensive experience in advising domestic and international companies in the pharmaceutical, FMCG and medical device sectors. Her expertise in product liability litigation is evidenced in high-profile cases pertaining to worldwide product recalls, and she receives extensive praise from satisfied clients: She is an expert in this subject, with a very good legal background. She is able to advise taking into account the business aspects of the clients."

      Who’sWho Legal 2016-2015 (Life Science) - Ewa Rutkowska recommended.

      Who’sWho Legal 2016-2015 (Product Liability Defence) - Ewa Rutkowska recommended.

      Expert Guides 2016-2015 (Product Liability) - Ewa Rutkowska recommended.

      Expert Guides: Women in Business Law 2016-2014 (Product Liability) - Ewa Rutkowska recommended.

      Chambers Europe 2015: Life Sciences: Band 1

      "Ewa Rutkowska receives praise from clients for her excellent communication skills. "She can easily explain things to non-lawyers, which is very important." comments an interviewee. Another adds: "She has a lot of energy and gives good, proactive advice."  Ewa Rutkowska has extensive experience in representing pharmaceutical clients in product liability litigation."

      Chambers Europe 2014 Life Sciences: Band 1

      "Sources say Ewa Rutkowska "has practical knowledge about local and EU law, and is very open to discussion and able to consider difference scenarios." She is particularly active in pharma and product liability litigation."

      Chambers Europe 2013 Life Sciences: Band 1

      "Ewa Rutkowska is revered as an "efficient lawyer with a brilliant mind and client-friendly approach." She has knowledge of the full range of life sciences law, although she has recently been particularly active in product liability cases. Sources also compliment her clear advice."

      Chambers Europe 2012 Life Sciences: Band 1

      "Peers describe practice co-head Ewa Rutkowska as "a highly skilled lawyer." She handles regulatory, commercial, product liability and reimbursement matters."

      PLC Which Lawyer 2012

      Life sciences: regulatory – Ewa Rutkowska recommended

      Life sciences: corporate & commercial - Ewa Rutkowska recommended

      Chambers Europe 2011 Life Sciences: Band 1

      "Ewa Rutkowska is also singled out as "a brilliant practitioner.""

      PLC Which Lawyer 2011

      Life sciences: regulatory – Ewa Rutkowska recommended

      Life sciences: corporate & commercial - Ewa Rutkowska recommended

      Chambers Europe 2010 Life Sciences: Band 1

      "Ewa Rutkowska is widely respected for her constructive approach: "She has a very good attitude, explains things carefully and in depth, and has the patience to push things through to the end without creating animosity.""

      Chambers Europe 2009 Life Sciences: Band 1

      "Both Ewa Rutkowska and rising star Agnieszka Zielińska-Krywoniuk are reported to be excellent at handling highly sensitive situations. Rutkowska is renowned for approaching issues from multiple perspectives and receives the highest of praise from one client, who is adamant that you couldn’t ask for anything more in a lawyer.""

      Chambers Europe 2008 Life Sciences: Band 2

      "Ewa Rutkowska is in charge of the life sciences group and handles regulatory, advertising and product liability issues. She is described by peers as an “accomplished lawyer with a likeable and easy-going approach.””

    • Marcin Kolasiński

      English

      Rzeczpospolita Ranking Kancelarii Prawniczych 2016

      Marcin Kolasiński recommended in Competition/Antitrust.

      Chambers Europe 2016 - Competition/Antitrust - Band 2

      Department head Marcin Kolasiński enjoys a long-standing reputation for competition law matters. I like his understanding of customer needs, speed in action and clarity in advice. He weighs the risks and objectively presents the pros and cons, a client says. He has strong practical experience of the pharmaceutical sector in particular.

      Who’sWho Legal 2016-2015 (Competition) – Marcin Kolasiński recommended.

      Expert Guides 2016-2015 - Competition/Antitrust – Marcin Kolasiński recommended.

       Chambers Europe 2015: Competition/Antitrust: Band 2

      "Marcin Kolasiński of Kieszkowska Rutkowska Kolasiński is best known for advising pharmaceutical clients on day-to-day competition issues concerning distribution, compliance and advertising. He is recommended by clients as a "sharp and experienced lawyer with excellent knowledge of the regulatory environment in Poland.""

      Chambers Europe 2014: Competition/Antitrust: Band 2

      "Marcin Kolasiński recently left Baker & McKenzie to set up boutique firm Kieszkowska Rutkowska Kolasiński Kancelaria Prawna Spółka Jawna with Paulina Kieszkowska-Knapik and Ewa Rutkowska. He moves up in the rankings due to excellent client feedback. Impressed interviewees say: "He is proactive and very much liked by business colleagues, and he can really explain matters in a way that people can understand." He has almost ten years' experience in advising clients in this area."

      Chambers Europe 2013: Competition/Antitrust: Band 3

      "Marcin Kolasiński is noted for his expertise in the pharmaceutical sector. Clients indicate that he is “worth every penny” and appreciate the way he “understands the business and addresses its needs.""

      Legal500 2013

      "Very professional” (…) Marcin Kolasiński heads the practice, and ‘creatively challenges the status quo to find new strategies’."

      Chambers Europe 2012 Competition/Antitrust: Band 3

      "Interviewees regard Marcin Kolasiński as "a creative, solution-driven and extremely knowledgeable practitioner.""

      PLC Which Lawyer 2012

      Competition/Antitrust - Marcin Kolasiński recommended

      Life sciences: competition/anti-trust - Marcin Kolasiński recommended

      Legal500 2012

      (…) Marcin Kolasiński has “a charismatic personality” and is recommended (…)

      Chambers Europe 2011 Competition/Antitrust: Band 3

      "Marcin Kolasiński is "a fantastic lawyer with great understanding of the pharmaceutical industry and the requirements of the competition authorities," say sources."

      Legal500 2011

      Clients praise Marcin Kolasiński’s "brilliant mind, analytic personality and pro-business approach"”.

      PLC 2011

      Competition/Antitrust - Marcin Kolasiński recommended

      Chambers Europe 2010 Competition/Antitrust: Band 3

      "Marcin Kolasiński is seen by sources as a dynamic leader of the practice. He is especially well regarded for his abilities in cases relating to the pharmaceutical industry."

      PLC Which Lawyer 2010

      Competition/Antitrust - Marcin Kolasiński recommended

      Chambers Europe 2009 Competition/Antitrust: Band 3

      "Marcin Kolasiński is singled out for showing great promise."

    • Natalia Łojko

      English

      Expert Guides Rising Star 2016-2015  - Natalia Łojko recommended.

      Chambers Europe 2016 - Life Sciences – Band 3

      Held out as a real expert in reimbursement law, Natalia Łojko provides ongoing advice relating to pharmaceutical law, IP law and the distribution of medicinal products.”

      Chambers Europe 2015: Life Sciences: Band 3

      Natalia Łojko is a highly regarded pharmaceutical lawyer focusing on reimbursement matters. She rises in the rankings in recognition of her experience in the field."

      Chambers Europe 2013 Life Sciences: Associate to watch

      Associate to watch Natalia Łojko is the team's rising star and she enters the rankings following a year of increasing prominence in the market, advising a wide range of pharmaceutical bodies on the new reimbursement law.”

    • Agnieszka Zielińska - Krywoniuk

      English

      Chambers Europe 2009 Life Sciences: Rising Star

      "Both Ewa Rutkowska and rising star Agnieszka Zielińska-Krywoniuk are reported to be excellent at handling highly sensitive situations. Rutkowska is renowned for approaching issues from multiple perspectives and receives the highest of praise from one client, who is adamant that you couldn’t ask for anything more in a lawyer.""

    • Magdalena Bąkowska

      English

      Expert Guides Rising Star 2016-2015 –  Magdalena Bąkowska recommended.

    • Marek Świerczyński

      English

      Chambers Europe 2016 - Life Sciences – Band 3

      Marek Świerczyński advises pharmaceutical bodies on a broad range of pharmaceutical legislation, with particular strength in clinical trials, reimbursement, advertising, distribution and IP."