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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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

06.06.2024

Swissmedic

Updated Information Sheet on Clinical investigations with medical devices v4.4

  • Annex 2 updated according to MDCG 2024-3

Updated Information Sheet on Performance studies with IVD v3.5

  • MDCG 2020-10 replaced by MDCG 2024-4
  • Annex A2 updated according to MDCG 2024-3.

 

European Commission

Publication of the Implementing Decision C(2024)3371 amending Implementing Decision C(2021) 2406 on a standardisation request for Electrotechnical Standardization.

The details of what is being amended are described in Annexes I through III and include:

  • the lists of Harmonised Standards (HS) under the EU MDR and IVDR to be reviewed or drafted by CEN/CENELEC, and the corresponding deadlines,
  • some additions/modifications to the requirements for certain standards, e.g. the request for a new EU-REP symbol (instead of EC-REP) in EN ISO 15223-1.
30.05.2024

European Commission

MDCG 2022-4 rev.2: Guidance on appropriate surveillance of transitional provisions per EU MDR Art. 120

This guidance document concerns the Notified Body which continues carrying on the surveillance of “legacy” devices until the end of the applicable transitional period in the EU MDR. The new revision introduces adjustments all over the document to align with Reg. (EU) 2023/607 regarding the new transitional provisions.

16.05.2024

Swissmedic

Swissmedic is grouping all information on clinical investigations (under the MedDO) and performance studies (under the IvDO) on an overarching webpage for Clinical Trials. The webpage includes an Announcement section, where the latest news concerns the application of MDCG 2024-4 for reporting serious adverse events during performance studies in Switzerland.

Swissmedic has published an updated version of its Checklist for Inspection of Medical Device Reprocessing Services (v.1.2 of 1-May-2024), available only in German and French.

 

European Commission

4 new MDCG templates have been published, for the assessment and re-assessment of Notified Bodies by the corresponding Designating Authority:

  • MDCG 2024-6 on the preliminary re-assessment under the EU MDR
  • MDCG 2024-7 on the preliminary assessment under the EU MDR
  • MDCG 2024-8 on the preliminary assessment under the IVDR
  • MDCG 2024-9 on the preliminary re-assessment under the IVDR
06.06.2024

Swissmedic

Updated Information Sheet on Clinical investigations with medical devices v4.4

  • Annex 2 updated according to MDCG 2024-3

Updated Information Sheet on Performance studies with IVD v3.5

  • MDCG 2020-10 replaced by MDCG 2024-4
  • Annex A2 updated according to MDCG 2024-3.

 

European Commission

Publication of the Implementing Decision C(2024)3371 amending Implementing Decision C(2021) 2406 on a standardisation request for Electrotechnical Standardization.

The details of what is being amended are described in Annexes I through III and include:

  • the lists of Harmonised Standards (HS) under the EU MDR and IVDR to be reviewed or drafted by CEN/CENELEC, and the corresponding deadlines,
  • some additions/modifications to the requirements for certain standards, e.g. the request for a new EU-REP symbol (instead of EC-REP) in EN ISO 15223-1.
30.05.2024

European Commission

MDCG 2022-4 rev.2: Guidance on appropriate surveillance of transitional provisions per EU MDR Art. 120

This guidance document concerns the Notified Body which continues carrying on the surveillance of “legacy” devices until the end of the applicable transitional period in the EU MDR. The new revision introduces adjustments all over the document to align with Reg. (EU) 2023/607 regarding the new transitional provisions.

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