Swiss Market Access For Medical Devices: What You Need To Know
Leonard (Leo) Eisner
#The60601Guy | #MedicalDevice Consultant | #ProductSafety #Compliance & #Regulatory | Evolving Medical Device #Standards
Written by Beat Keller Eisner Safety Consultants Expert
We welcome Beat Keller as one our recent experts to the Eisner Safety Consultants team.? Beat’s?expertise comprises the IEC 60601 series, risk management, software, verification, validation, regulatory affairs, and quality management. In the regulatory/quality area, he focuses on the EU MDR, Swiss MedDO, and UK MDR.? He is a member of standardization working groups in Switzerland, Europe (CENELEC), and internationally with IEC.? He is one of our internationally recognized medical device experts from around the world we have welcomed to the ESC team recently and are thrilled to have his expertise to round out our team.
Swiss Market Access for Medical Devices
As there are many rumors about Swiss market access for medical devices, this article will provide you with an up-to-date overview of how to get access.
Important note: this represents the status as of July 12, 2024, and might have changed in the meantime, please reach out to Leonard (Leo) Eisner of Eisner Safety Consultants and schedule a meeting if you have a project and need up-to-date information in the future!
Switzerland and the EU, a long story short
Switzerland is neither part of the EU nor the EEA and therefore, in principle not part of the CE market. Before the current MDR came into force, there was a bilateral agreement between the EU and Switzerland which contained a mutual recognition agreement for medical devices. Switzerland recognized EU conformity assessments and the EU recognized Swiss conformity assessments. Due to different disputes, this agreement was not updated for the MDR and since then, the EU does not recognize Swiss conformity assessments anymore and the last Swiss notified body gave its medical device certification up. Switzerland decided to unilaterally recognize EU conformity assessments.
Conformity Assessment for Swiss Market
The Swiss MedDO is in principle the same as the European MDR, with the same General Safety and Performance Requirements (GSPRs), the same classification rules, and the same conformity assessment routes. So, if you already have a CE Mark, per the EU MDR, on your device, you can directly jump to the registration and labeling requirements.
If you’ve not yet performed a conformity assessment per the MDR, the first thing you need to do is to classify your medical device per EU MDR (the Swiss MedDO refers to the EU MDR).
If you are a non-sterile, non-measuring, non-surgical-reusable-instrument class I device, you’re eligible for self-declaration. So, you can either declare conformity with the EU MDR and affix the CE mark, or you declare conformity with the Swiss MedDO and affix the Swiss MD symbol. As the CE declaration covers a broader market, it probably makes sense to use that if you can comply with the registration and labeling requirements of the EU MDR, as well.
For all other devices, a notified body is required. As SQS, as the last standing Swiss notified body for medical devices, gave up, there are no more, and you are forced to go to an EU notified body for a conformity assessment per the EU MDR.
Labeling and registration requirements
Switzerland has similar labeling and registration requirements as the European Union in the MDR.
The above economic operators receive a CHRN upon their registration.
The requirements for distributors are equivalent to the EU MDR, the distributors need to be marked in the labeling but do not require registration in Swissdamed.
Symbols for Swiss Market Access
Note: For EU symbols and eIFU Leonard (Leo) Eisner wrote this article: MedTech Europe 2 Useful Factsheets Medical Device Symbols & eIFUs + Bonus Material
And what about the FDA recognition by Switzerland?
There was a motion (20.3211) of a Councillor of States which was accepted by the Swiss National Council and the State Council that requires the Federal Council of Switzerland, to adopt national laws to enable Switzerland to accept medical devices with FDA approval/clearance. The reason is, that on the European Market, currently patients are not treated and sometimes even die because new and orphan devices are missing (thank you MDR). The idea is, to replace these missing devices with FDA-approved/cleared devices to ensure the welfare of Swiss patients.
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This process of adopting national laws is still in progress and an FDA approval/clearance does not allow Swiss market access so far. It is currently unknown when the Federal Council will provide a solution.
You can find the motion here (in German only).
There is a Mutual Recognition Agreement between the FDA and Swissmedic, but it doesn't cover Medical Devices only the inspections of medicinal product manufacturers.
Useful links
Glossary
CHRN = Swiss Single Registration Number
EU = European Union
EEA = European Economic Area
FDA = Food and Drug Administration, competent authority of the United States of America
MDR = European Medical Device Regulation
Swiss MedDO = Swiss Medical Device Ordinance
Swissdamed = Swiss Eudamed equivalent, database containing economic operators and medical devices.
Swissmedic = competent authority of Switzerland
SQS = Former medical device notified body from Switzerland
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If you need support for your medical device for the EU, UK, Swiss, Japanese, Chinese, US, and Canadian markets and more with information to be provided by the manufacturer (labeling, user manual, IFUs, symbols, etc.) we have expanded our resources at Eisner Safety Consultants to provide you with what you need whether for product safety compliance, EMC, software, or regulatory needs. Feel free to schedule a meeting with Leonard (Leo) Eisner the "IEC 60601 Guy" to discuss your needs.
#MedicalDevices #RegulatoryCompliance #SwissMarket #Healthcare #SwissAccess #Symbols #Labeling #RegulatoryAffairs #QualityAssurance #Regulatory #Quality #EUMDR #MDR
Chief Operating Officer @ OneDirect Health Network where we empower people to take charge of the rehab journey by offering innovative products and next level customer service.
1 个月Leonard, thanks for sharing!
Founder, Chairman and Principal Consultant
4 个月Thanks Leo. Pls note that foreign manufacturers don’t get a CHRN number yet and Swissdamed is only available starting from August 2024. In case anybody is in need of a CH-REP, pls reach out to me!
Quality Assurance & Regulatory Compliance Director | Qualified Person | Health Care | Manufacturing, Distribution | Go-to-market organization | Product Registration
4 个月ISO 13485 gives the definition of labelling às you know As for article 14 I understand your poitis fair but keep in mind that based SwissMedic documents (I don't have to it on hand but I am referring to the one talking about importer etc) the interpretation is not the same as in EU the importer is not supposed
Quality Assurance & Regulatory Compliance Director | Qualified Person | Health Care | Manufacturing, Distribution | Go-to-market organization | Product Registration
4 个月Hi Leonard Where the Ordinance says that the distributor needs to be on the label? Art 16 points to MDR Annex I chapter III Thanks
Certification and Inspection Officer - Medical Devices
4 个月Thank you Leo ??