The IvDO has been published and Swissmedic has revised its guidance documents accordingly. Read the details: HERE
On 4 May 2022 Swissmedic updated its website to state that the:
“provisions of the EU IVDR were transferred to a new Swiss ordinance on In Vitro Diagnostic Medical Devices (IvDO)…”
And that the:
“provisions entered into force on 26 May 2022, thereby completing the revision of Swiss medical devices legislation.”
So now what?
The German language provisional document is available here, on Swiss Medtech’s site. The final version will be published in the Swiss Federal Gazette.
Will Switzerland continue to accept EU CE Marking?
Yes, Swissmedic will continue to recognize European CE marking for medical devices and IVDs. Per Swissmedic:
“Furthermore, the marketability of medical devices with an EU conformity assessment (CE marking) will continue to be recognised unilaterally.”
Will the EU IVDR Progressive Rollout dates be recognized in Switzerland?
Yes, Swissmedic has implemented the same IVDR progressive rollout dates in Switzerland. Art. 82 states:
“Provided that the following products continue to comply with the previous law from May 26, 2022 and there are no significant changes in the design and intended purpose of the product in question, they can be placed on the market or put into operation up to the following dates:
Products with a valid certificate under Article 81*: until May 26th 2025:
Products for which the participation of a notified body was not required under the previous law as part of the conformity assessment procedure, but for which such is required under this Ordinance and which have a declaration of conformity issued before 26 May 2022 under the previous law:
Article 82 also outlines the dates by which legacy IVD products can continue to be made available on the market/put into service, which align with the IVDR.
For more information on the IVDR progressive rollout, please read: IVDR Progressive Rollout Approved
*This refers to devices with Notified Body issued IVDD CE marking certificates.
Swiss Authorized Representative (CH-REP)
A Swiss Authorised Representative is required for non-Swiss IVD manufacturers. This includes European manufacturers, who will no longer have single market access to Switzerland as of 26 May 2022.
Deadlines to appoint your Swiss Authorised Representative (CH-REP) are:
For EU/EEA manufacturers or manufacturers with an EU/EEA-based EU Authorized Representative:
The CH-REP must notify Swissmedic once they have been appointed by the manufacturer.
The device labeling should include the Swiss Authorized Representative’s information after Swissmedic has been notified. However, per Article 87, IVDR CE marked devices may provide the Swiss Authorized Representative’s details in a document enclosed with the product until 31 March 2025, instead of on the product label itself. The exception is if the device is intended for self-testing, in which case this allowance does not apply.
The Swiss Authorized Representative is responsible for reporting vigilance and trend reports to Swissmedic. Unlike in Europe, the manufacturer cannot submit these directly to Swissmedic on their own.
Regarding ‘legacy’ device CH-REP and labeling requirements, we anticipate that Swissmedic will provide further clarification in the coming weeks. Swissmedic does require appointment of a CH-REP for MDD legacy devices, so manufacturers should expect the same for legacy IVD devices. If this occurs, the above dates may apply to all IVDs, whether IVDD or IVDR CE marked.
Otherwise, the IvDO generally references the IVDR articles for further compliance obligations.
For more information about the role of the CH-REP, please read: Switzerland Authorized Representative
Swiss Importer
A Swiss-based importer is required. An EU Importer is not recognized in Switzerland.
The Swiss importer is defined as ‘any natural or legal person established in Switzerland who places a product from abroad on the Swiss market’. i.e., the company that first takes a product from outside Switzerland and places it onto the Swiss market automatically becomes the Importer.
Like the EU, Switzerland also requires that the Importer’s name and address be included on the product, its packaging or in a document accompanying the device. However, Swissmedic has a different interpretation of ‘document accompanying the device’ than the EU, which can be found under the Importer section: here
Swissmedic may provide a transition period for the importer’s information to be supplied with certain types of IVD devices, as they did for medical devices. Casus will publish an update if so.
Otherwise, the IvDO generally references the IVDR articles for further compliance obligations.
Economic Operator Registration
Swiss Manufacturers, Swiss Authorized Representatives and Swiss Importers must obtain a unique Swiss registration number ( CHRN ). Non-Swiss manufacturers are not required to obtain a CHRN.
Swiss Manufacturers, Authorized Representatives and Importers must:
For more information about the CHRN, please read: What is a CHRN?
IVD Medical Device Registration
Until the requirements under Articles 24, 26 and Annex VI* of the IVDR take effect, Swiss IVD medical device registration requirements will remain as is.
Swissmedic’s current IVD registration requirements are outlined on their page: Notification of IVD medical devices
We expect that it will be updated soon to reflect the IvDO/IVDR.
*These are related to UDI and EUDAMED registration of devices and economic operators.
Switzerland specific Declaration of Conformity?
Since Switzerland requires a CHRN instead of SRN, and appointment of a Swiss Authorized Representative, is a Swiss Declaration of Conformity required?
No, a Swiss specific Declaration of Conformity is not required; your EU Declaration of Conformity is sufficient.
While this is not stated in the MeDO or IvDO, Swissmedic has communicated the following informally via email:
“No Switzerland-specific evidence of conformity is required, i.e. the indication of the CHRN, the Swiss authorised representative (CH-REP) or the Medical Devices Ordinance on the evidences of conformity (e.g. the declaration of conformity) is not mandatory.”
Person Responsible for Regulatory Compliance (PRRC)
Does your Person Responsible for Regulatory Compliance (PRRC) need to be based in Switzerland?
No, Swissmedic does not require that the Swiss manufacturer or Swiss Authorized Representative’s PRRC be located in Switzerland.
Swissmedic’s website states:
“The Medical Devices Ordinance (MedDO) does not give rise to a requirement for the PRRC to be domiciled in the same jurisdiction in which the authorised representative or manufacturer is domiciled. What is relevant is that the PRRC is organisationally and professionally integrated over the long term and performs its tasks.”
We expect that the webpage will shortly be updated to also include reference to the IvDO.
There has not been discernable progress on the lapsed Mutual Recognition Agreement ( MRA ). The situation is complicated and the MDR/IVDR are the ‘innocent bystanders’ of larger political issues.
That said, the IvDO heavily references the IVDR, indicating that the Swiss Federal Council expects to eventually rejoin the European Single Market .
For more background, please read: Switzerland is a Third Country for medical devices
Swissmedic just released this update. Expect more details to follow shortly.
Swissmedic will likely update their Information Sheets and website FAQs in the coming weeks. Therefore, some of the above information will continue to be refined. For example, their “Obligations for authorized representatives, importers and distributors” will likely include clarity on how IVD legacy devices will be managed.
Check back for Switzerland updates. Casus will be reporting on the important details as they are released.
