top of page
Chipy DNA

Medical devices and IVD

Knowledge. Quality. Commitment.

We have comprehensive and practical knowledge of legal regulations relevant to the market of medical devices and in vitro diagnostic (IVD) medical devices. We advise at all stages of the "life cycle" of products, from clinical trials or performance evaluation, certification, manufacturing and marketing, through  by advising in tender procedures and in connection with advertising and market communication regarding products, to disputes with regulatory authorities and competitors, and issues related to product safety.

How can we help you?

Clinical evaluation

  • Comprehensive consultancy in the field of conducting clinical evaluation.

  • Drafting contracts for clinical trials.

  • Negotiating with researchers, centers and CRO.

  • Preparing and reviewing clinical trial documentation.

  • Advice on obtaining permits and opinions necessary to conduct a clinical trial.

  • Advising on the protection of personal data collected in the course of clinical trials

Conformity assessment

  • Advice on authorisation and notification of a notified body.

  • Advice on the classification and qualification of the product.

  • Advice on labelling and instructions for use.

  • Support in the process of obtaining a certificate of compliance.

Placing on the market and use

  • Comprehensive support for the manufacturer and the authorised representative in reporting the product to the President of the Office.

  • Comprehensive support for the distributor and importer in notifying the President of the Office of putting into service.

  • Introducing changes to the data covered by the notification.

Financing from public funds

  • Help in building a market access strategy.

  • Representation in reimbursement proceedings, including negotiations with the Ministry of Health.

  • RSS development.

  • Legal representation in disputes with the National Health Fund and the Ministry of Health.

  • Consultancy in the field of procurement orders.


  • Comprehensive legal support in conducting advertising campaigns.

  • Legal evaluation of marketing materials.

  • Drafting contracts with service providers.

  • Preparation or evaluation of internal procedures regarding marketing activities addressed to medical professionals, including adapting procedures to national and European codes of good practice (MedTech Europe).

  • Advice on umbrella branding.

  • Advice on the protection of personal data.


  • Negotiating and drafting distribution agreements.

  • Development of distribution models.

  • Consultancy and representation in the field of public procurement.

  • Export support, including obtaining a certificate of free sale.

Safety and quality

  • Legal support for activities related to medical incidents (e.g. FSCA).

  • Advising on internal procedures related to safety.

  • Support in relations with the President of the Office.

  • Advice on recalling a product from the market.


  • Preparation or evaluation of internal procedures concerning:

    • marketing activities targeted at medical professionals,

    • tenders, including tender communication,

    • quality defects of products and product recall,

    • transparency of activities and anti-corruption policy,

    • response in the event of an inspection,

    • protection of the company's intangible assets,

  • Audits of planned or ongoing research or educational projects.

Relations with public administration

  • Representation in proceedings before the Ministry of Health, URPL, UOKiK or other authorities in cases concerning, among others:

    • placing on the market and use

    • advertising activities carried out

    • distribution models used

    • suspending or recalling a product from the market

    • practices restricting competition or infringing collective consumer interests

  • Stakeholder representation in discussions with decision-makers.

Relationships with competitors and patients

  • Disputes with competitors:

    • within the scope of infringement of rights under patents, SPC, trademarks or other rights on intangible property

    • in the field of acts of unfair competition

    • in the field of industry codes

  • Drafting technology transfer agreements, permits, license agreements and other commercial agreements.

  • Responsibility for a dangerous product (medical incidents).

  • Management of crisis situations.


  • Representing industry organizations in the legislative process.

  • Legislative monitoring.

  • Creating reports and legislative proposals.

Implementation of EU Regulations

  • Adjusting the company to new regulations.

  • Preparation or evaluation of internal procedures.

  • Conducting trainings.

bottom of page