We simplify market access for medical devices

Our proven experts guide you through medical device CE certification. You gain hands-on support in regulatory affairs and quality management, ensuring regulatory compliance. Plus, as a Swiss Authorised Representative, we facilitate your access to the medical device market in Switzerland.

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One partner for your medical device compliance

Obtain CE mark with proven experts

Decomplix becomes your professional compliance partner. We guide you to your CE mark and ensure your compliant quality management. You get expert advice on how to overcome key regulatory hurdles on the way to getting your product to market.

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Swiss Authorised Representative

As your Swiss Authorised Representative (CH-REP), we ensure your market access in Switzerland. Our high level of compliance and regulatory knowledge was confirmed with a Swissmedic inspection with no non-conformities in April 2022.

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Compliance for Swiss medical device importers

We offer consulting, training and ready-to-use templates for procedures, checklists and other tools for the compliant import of medical devices into Switzerland. Our proven experts tailor the processes together with you to your needs for fixed price.

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CE-certified medical device software

Transform your algorithm into a CE-certified medical device software in less than a year. Decomplix, with its partner platform Evidencio, can offer a fast, proven, de-risked solution.

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100+ medical device and in-vitro diagnostic companies of all shapes and sizes trust Decomplix — from startups to corporates, from Switzerland to all around the globe.

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Regulatory Affairs News

17.04.2025

Team NB

A few position papers are published:

Best Practice Guidance for TD under Annex II & III of EU MDR v.3

  • 79 pages instead of 47 pages in the last version, various section updates to bring content up to date.
  • Addition of common pitfalls observed by NBs.
  • Significant rewriting of the Clinical and PMS sections.
  • Clarified wording and improved formatting (including table of abbreviations).

 

Position Paper on European AI Act v.2

  • Foreseeable lack of resources to implement the Regulation at national level
  • Pending clear definition of the terms “substantial modification” and “significant  change”
  • Possible duplication of administrative effort for post-market surveillance and vigilance
  • Embedding fundamental rights principles in standards is expected
  • EC guidelines of AIA could bring more detail and specific guidances (case-by-case decisions)
  • The “Safety component” allows to conclude that a potential malfunction of an AI system constitutes a “device deficiency”
  • The NB’s challenges regarding data requirements and data governance
  • A more pragmatic approach to implementing/interpreting AIA is welcome

 

Position Paper on IVDR Certification Process

  • General procedure for submitting an application for IVDR certification.
  • Special procedures for each classification are mentioned
10.04.2025

European Commission

 

New Harmonised Standards under the EU MDR have been adopted via the Implementing Decision 2025/679 – HS for sterilization of medical devices

  • EN 556-1:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices
  • EN 556-2:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 2: Requirements for aseptically processed medical devices’

 

New Harmonised Standards under the IVDR have been adopted via the Implementing Decision 2025/681 – HS for medical gloves for single use, sterilization of medical devices and patient handling equipment used in ambulances

  • EN 455-1:2020+A2:2024 Medical gloves for single use – Part 1: Requirements and testing for freedom of holes
  • EN 455-2:2024 Medical gloves for single use – Part 2: Requirements and testing for physical properties
  • EN 556-1:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices
  • EN 556-2:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 2: Requirements for aseptically processed medical devices
  • EN 1865-2:2024 Patient handling equipment used in ambulances – Part 2: Power assisted stretcher
  • EN 1865-6:2024 Patient handling equipment used in ambulances – Part 6: Powered chairs’.

 

Publication of the AI Continent Action Plan. It covers the following aspects:

  • A large-scale AI computing infrastructure is being developed
  • EU internal market for data and data labs within EU AI factories will increase access to high-quality data
  • Commission will launch apply AI strategy, e.g. integrate AI into healthcare sector
  • Bring skilled experts/workers to EU, help workers upskill/reskill
  • Simplifying the implementation of the AIA

 

Swissmedic

 

A few new versions of forms are published:

03.04.2025

Swissmedic

 

Updated revision of the Information Sheet on Medical device derogations (rev. 4.1). The changes are limited to:

  • Clarification on Point 10 of Section 2.3: the justification as to why the placing on the market of the non-conforming device is in the interest of public health shall include a clear explanation of the risks of absence of the device. 
  • Removal of Point 14 of Section 2.3: proof of the benefitrisk analysis is not needed.

 

ISO

 

New version of ISO 15223-1:2021 amd 1: 2025 on symbols to be used with information to be supplied by the manufacturer. Changes are limited to:

  • Using XX REP for the authorised representative
  • Replacing EC REP symbol by EU REP.
17.04.2025

Team NB

A few position papers are published:

Best Practice Guidance for TD under Annex II & III of EU MDR v.3

  • 79 pages instead of 47 pages in the last version, various section updates to bring content up to date.
  • Addition of common pitfalls observed by NBs.
  • Significant rewriting of the Clinical and PMS sections.
  • Clarified wording and improved formatting (including table of abbreviations).

 

Position Paper on European AI Act v.2

  • Foreseeable lack of resources to implement the Regulation at national level
  • Pending clear definition of the terms “substantial modification” and “significant  change”
  • Possible duplication of administrative effort for post-market surveillance and vigilance
  • Embedding fundamental rights principles in standards is expected
  • EC guidelines of AIA could bring more detail and specific guidances (case-by-case decisions)
  • The “Safety component” allows to conclude that a potential malfunction of an AI system constitutes a “device deficiency”
  • The NB’s challenges regarding data requirements and data governance
  • A more pragmatic approach to implementing/interpreting AIA is welcome

 

Position Paper on IVDR Certification Process

  • General procedure for submitting an application for IVDR certification.
  • Special procedures for each classification are mentioned
10.04.2025

European Commission

 

New Harmonised Standards under the EU MDR have been adopted via the Implementing Decision 2025/679 – HS for sterilization of medical devices

  • EN 556-1:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices
  • EN 556-2:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 2: Requirements for aseptically processed medical devices’

 

New Harmonised Standards under the IVDR have been adopted via the Implementing Decision 2025/681 – HS for medical gloves for single use, sterilization of medical devices and patient handling equipment used in ambulances

  • EN 455-1:2020+A2:2024 Medical gloves for single use – Part 1: Requirements and testing for freedom of holes
  • EN 455-2:2024 Medical gloves for single use – Part 2: Requirements and testing for physical properties
  • EN 556-1:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices
  • EN 556-2:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 2: Requirements for aseptically processed medical devices
  • EN 1865-2:2024 Patient handling equipment used in ambulances – Part 2: Power assisted stretcher
  • EN 1865-6:2024 Patient handling equipment used in ambulances – Part 6: Powered chairs’.

 

Publication of the AI Continent Action Plan. It covers the following aspects:

  • A large-scale AI computing infrastructure is being developed
  • EU internal market for data and data labs within EU AI factories will increase access to high-quality data
  • Commission will launch apply AI strategy, e.g. integrate AI into healthcare sector
  • Bring skilled experts/workers to EU, help workers upskill/reskill
  • Simplifying the implementation of the AIA

 

Swissmedic

 

A few new versions of forms are published:

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