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Cyber Resilience Act for Healthcare Devices & MedTech in Poland

A practical country and industry compliance guide — obligations, evidence, and next steps.

Direct answer

Healthcare Devices & MedTech manufacturers in Poland must classify their products by CRA category, apply Annex I essential cybersecurity requirements, establish a vulnerability handling process, prepare technical documentation and CE marking, and report actively exploited vulnerabilities to ENISA. Full obligations apply from 11 December 2027; vulnerability reporting starts 11 September 2027.

What are the CRA obligations for Healthcare Devices & MedTech in Poland?

Healthcare Devices & MedTech manufacturers in Poland must classify their products by CRA category, apply Annex I essential cybersecurity requirements, establish a vulnerability handling process, prepare technical documentation and CE marking, and report actively exploited vulnerabilities to ENISA. Full obligations apply from 11 December 2027; vulnerability reporting starts 11 September 2027.

  • Map all connected medical devices against both MDR GSPR Annex I and CRA Annex I requirements
  • Leverage EN 62443-4-2 certification as evidence for CRA Annex I compliance
  • Establish post-market cybersecurity surveillance aligned with MDR Article 83 and CRA Article 13
  • Coordinate vulnerability disclosure with both competent authority (NCA) and ENISA
  • Define cybersecurity support lifetime aligned with expected medical device use (often 7-15 years)
CountryPoland
IndustryHealthcare Devices & MedTech
RegulationRegulation (EU) 2024/2847
SupervisionUKE (Office of Electronic Communications) is likely the Polish CRA market-surveillance authority for telecom and connected products
Source: Official Journal of the EU — Cyber Resilience Act for product manufacturers and software developersReviewed:
Cyber Resilience Act for product manufacturers and software developersRegulation (EU) 2024/2847, Articles 3, 6, 13, 14 and Annex I

The CRA applies to manufacturers and importers of products with digital elements (hardware and software) sold or made available in the EU market. It requires essential cybersecurity requirements, CE marking, vulnerability handling throughout the product lifetime, and incident reporting to ENISA. Critical and important product categories face conformity assessment by notified bodies.

2027-12-11Full CRA obligations for all products

All essential cybersecurity requirements, secure-by-design obligations, CE marking, and vulnerability management obligations apply from 11 December 2027.

Source: Regulation (EU) 2024/2847, Articles 3, 6, 13, 14 and Annex I

Healthcare Devices & MedTech CRA checklist

Action checklist
Classify your product by CRA category

Determine whether your product is Default (most products), Important Class I (e.g. browsers, password managers, VPNs, network monitoring tools), Important Class II (firewalls, IDS/IPS, microprocessors), or Critical (HSMs, smart cards). Category determines conformity assessment route.

Articles 6, 7, Annex III, Annex IV

Apply Annex I essential cybersecurity requirements

Implement secure-by-default and secure-by-design: minimal attack surface, no default passwords, access control, encrypted communications, data minimisation, integrity protection, vulnerability remediation capability, and security update mechanism.

Article 13, Annex I Part I

Establish a vulnerability handling process

Document a coordinated vulnerability disclosure policy, a process to receive and assess security reports, a remediation and update release workflow, and a communication channel for security researchers.

Article 13, Annex I Part II

Prepare technical documentation and Declaration of Conformity

Compile technical documentation covering product design, risk assessment, essential requirements compliance evidence, test results, and instructions for users. Issue an EU Declaration of Conformity before affixing the CE mark.

Articles 26, 28, 32

Report actively exploited vulnerabilities and severe incidents

Notify ENISA (via national CSIRT) within 24 hours of becoming aware of an actively exploited vulnerability or severe incident. Provide early warning, followed by a full notification within 72 hours and a final report within 14 days.

Article 14

Plan security support lifecycle

Commit to a support period during which security updates will be released — minimum 5 years or the expected product lifetime, whichever is longer. Communicate the end-of-support date to users.

Articles 13(8), 13(9)

What is specific to Poland

UKE (Office of Electronic Communications) is likely the Polish CRA market-surveillance authority for telecom and connected products. CERT.PL will be the receiving CSIRT for CRA incident and vulnerability notifications. Polish manufacturers exporting to larger EU markets should also align with BSI and ANSSI expectations in addition to UKE requirements.

Priority actions for Healthcare Devices & MedTech

  • Map all connected medical devices against both MDR GSPR Annex I and CRA Annex I requirements
  • Leverage EN 62443-4-2 certification as evidence for CRA Annex I compliance
  • Establish post-market cybersecurity surveillance aligned with MDR Article 83 and CRA Article 13
  • Coordinate vulnerability disclosure with both competent authority (NCA) and ENISA
  • Define cybersecurity support lifetime aligned with expected medical device use (often 7-15 years)

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Informational only. This page is not legal advice — consult qualified counsel for your specific situation. Last reviewed: .