Integrating Swiss MedDO and IvDO into your QMS

Despite the Swiss Medical Devices Ordinance 812.213 (MedDO) having entered into force on May 25, 2021, and In Vitro Diagnostic Medical Devices Ordinance 812.219 (IvDO) having entered into force on May 25, 2022, many manufacturers (in particular EU-based manufacturers) have not appropriately adapted their Quality Management System (QMS) for conformity with these regulations. Instead, as each ordinance is intertwined with the MDR and IVDR, such manufacturers have erroneously believed that QMS conformity with the EU MDR and or IVDR is sufficient for conformity with Swiss requirements.

MeDO and IvDO Requirements to Ensure QMS

In this article, we cover several MedDO/IvDO requirements for which manufacturers should ensure their QMS has been revised for compliance in light of the absence of an Institutional Framework Agreement (IFA) and no update to the Mutual Recognition Agreement (MRA) between Switzerland and the EU. 

Control of Swiss Economic Operators

Article 51 (MedDO)/Article 44 (IvDO) establish the obligations of the Swiss Authorized Representative (CH-REP), an economic operator that must be designated by all device manufacturers not located in Switzerland, and who is responsible for the formal and safety-related aspects of placing devices on the market. While the rights and obligations of the CH-REP are governed by Article 11 of the MDR/IVDR and a mandate must be in place between both parties, in Switzerland the MedDO/IvDO allows for the manufacturer and CH-REP to contractually agree that, instead of the CH-REP keeping available a copy of the technical documentation, the manufacturer shall, on request, submit the documentation straight to Swissmedic within seven days. 

Just as Swiss importers and distributors should be managed by manufacturers in accordance with their resource management/purchasing controls, as the CH-REP is a supplier responsible for the formal and safety-related aspects of placing devices on the market, manufacturers should also ensure that the CH-REP is also managed in accordance with such controls, including initial qualification and re-qualification of their CH-REP based on the results of monitoring against established requirements. Records of qualification and re-qualification results should be maintained by the manufacturer should be maintained as objective evidence. 

In summary, the CH-REP mandate and (re)qualification records are critical QMS records demonstrating control of this Swiss economic operator. 

Vigilance & Field Safety Corrective Actions (FSCAs)

Conformity with Swiss vigilance and FSCA requirements is one particular area in which we’ve noted EU manufacturers not adequately establishing QMS controls. This is largely associated with these manufacturers having established vigilance and FSCA procedures in which they report directly to competent authorities in the EU and have applied previous MEDDEV guidance (specifically MEDDEV 2.12-1 rev. 8) which includes provisions related to incident and FSCA reporting in Switzerland which are no longer relevant under the requirements of MedDO and IvDO. 

Article 66 (MedDO) / Article 59 (IvDO) both clearly establish that where a CH-REP is required (i.e. where manufacturers are located outside of Switzerland), it is responsible for: 

• • Reporting any serious incidents involving the device in question that have occurred in Switzerland as soon as they become aware of them and submitting final reports setting out the findings from investigations, conclusions, and (where relevant) indicating corrective actions to be taken in relation to reported serious incidents. 
  • Reporting FSCAs undertaken in Switzerland. 
  • Submitting trend reports to Swissmedic without being requested to do so. 

The transfer of the above responsibilities from the manufacturer to the CH-REP must be agreed in writing in the mandate between the manufacturer and CH-REP.Therefore, manufacturers located outside of Switzerland must ensure that their vigilance and FSCA procedures are updated to reflect reporting processes and responsibilities for Switzerland that are aligned with the MedDO/IvDO and the mandate.

Additionally, in line with the EU publication of the updated Manufacturer Incident Report (MIR) form (7.3.1), Swissmedic has released a new guidance document detailing how to complete an MIR, focusing on reports for devices from manufacturers or SPPPs domiciled outside Switzerland and Liechtenstein. The Swiss requirements for these reports are summarized in this news post.

It is also important to note that the CH-REP needs to be included in the distribution list when communicating with Swissmedic on any Vigilance topics.

Labeling Within the Framework of QMS

The three official languages of Switzerland are French, German, and Italian, and while manufacturers of CE-marked devices should already be familiar with localization requirements about device labeling and have translation controls established within the framework of their QMS (e.g. translator qualification by purchasing controls), the MedDO/IvDO establish additional considerations for certain types of devices. 

Under Article 16 (MedDO) / Article 15 (IvDO), the product information (labeling and instructions for use (IFU)) may be provided in fewer than the three official languages of Switzerland or English, provided that the: 

• • Device is supplied exclusively to healthcare professionals or is a custom-made or concerns a medical device manufactured and used in healthcare institutions. 
  • User meets the necessary professional and linguistic requirements and qualifications and agrees. 
  • Protection of patients, users and third parties are ensured. 
  • The efficacy and performance of the medical device are not placed at risk. 

While self-testing IVDs are outside the scope of the above exceptions, it should be noted that all information required under Chapter III, Annex I of the MDR/IVDR should be easily understandable and written in the three official Swiss languages. 

Additionally, if the above conditions are applicable, manufacturers must still be prepared to provide additional information to users in one of the official languages of Switzerland, if requested. 

There are also MedDO/IvDO labeling requirements about importer and CH-REP identification, including: 

• • Importers indicating on the device or on its packaging or in a document accompanying the device (e.g. invoice), their name, place of business, and the address where they can be contacted (Article 53 (MedDO) / Article 46 (IvDO)) 
  • The name and address of the registered place of business of the CH-REP shall be on the device label, with the following exceptions: 

• • • For Class I devices and for systems ad procedure packs that are placed on the market, this information may be included in a document accompanying the device until 31 July 2023 (i.e. this exception is no longer applicable). 
    • For devices which are not intended for self-testing and are placed on the market, this information may be included in a document accompanying the device until 31 March 2025. 

Manufacturers should therefore ensure that their labeling control (including design-related) procedures are aligned with MedDO/IvDO requirements. 

Learn More About MeDO and IvDO Concerning QMS with MedEnvoy

This article provides a brief overview of several considerations for manufacturers in ensuring the integration of MedDO/IvDO conformity in their QMS, however, if you have any questions regarding conformity with Swiss regulatory requirements or require a Swiss-authorized representative or importer services, get in touch. 

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