Swiss Medtech Guidance Document for Legacy Devices Compliance

Swiss Medtech released a guidance document tailored for economic operators in Switzerland. It delineates the necessary steps for ensuring compliance with regulatory standards when placing “legacy devices” (medical devices CE-marked under the MDD or AIMDD directives) on the Swiss market. This guidance takes into account the provisions of the new Medical Device Regulation (MDR) EU 2017/745 and its amendment Regulation (EU) 2023/607, as integrated into the Medical Devices Ordinance (MedDO). 

Devices that were CE-marked under MDD/AIMD and will not be transitioned to the MDR (Medical Device Regulation (EU) 2017/745) are ineligible to benefit from the transition period outlined in Regulation (EU) 2023/607. Failure to place these devices on the Swiss market before May 26, 2024, renders them unsellable, requiring their disposal by May 27, 2024, even if they are already in your Swiss warehouse. 

The Swiss Medtech document thoroughly outlines the concept of “placing on the market,” offering comprehensive flowcharts designed for Swiss manufacturers, importers, and distributors. These aids assist in determining the latest permissible date for market placement and delve into the associated risks and strategies for ensuring continued availability of these devices in Switzerland prior to the looming deadline of May 26, 2024. 

Read the full Swiss Medtech guidance document here. 

For devices previously CE-marked under MDD/AIMD and undergoing transition to the MDR, the extension of the transitional period beyond May 26, 2024, is contingent upon meeting the criteria outlined in Article 101 of the MedDO. 

As a reminder, the main requirements to be met in this case are:  

• • The devices comply with the old legislation (Directive 93/42/EEC) i.e. were CE-marked according to this regulation.  
  • They have not undergone any significant changes in their design or intended purpose.  
  • The devices do not represent an unacceptable risk to health or safety.  
  • The manufacturer must put in place a quality management system (QMS) in accordance with MDR Article 10(9) no later than 26 May 2024.  
  • The manufacturer has lodged a formal application for the medical device with a Notified Body domiciled in an EU or EEA member state* no later than 26 May 2024. Turkish NBs are excluded because Turkey is not an EU- or EEA member state. 
  • The manufacturer has signed a corresponding written agreement with his Notified Body no later than 26 September 2024.  

Demonstrating compliance with these six requirements can be achieved through a manufacturer’s self-declaration (for a template see here). Alternatively, other options such as a Confirmation Letter from the relevant Notified Body are also viable. 

Alternative requirements include obtaining a derogation from the conformity assessment procedure granted by Swissmedic or a competent EU/EEA authority or securing approval from a competent authority enabling the manufacturer to conduct the applicable conformity assessment procedure within a specified timeframe. 

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For companies navigating this regulatory landscape, we at MedEnvoy stand ready to provide support and expertise to ensure continued product availability and compliance with Swiss regulatory standards. Don’t hesitate to reach out for assistance in navigating these complexities and safeguarding your market presence. 

Learn how MedEnvoy can assist you:

• • Swiss Authorized Representative
  • Swiss Regulatory Importer
  • Consulting Services