As of 26 May 2022 the new regulations become applicable to medical devices including in vitro diagnostic medical devices taking consideration of transitional provisions. The transitional provisions indeed offer some flexibility for economic operators, particularly manufacturers, to adapt their quality management system (QMS) and product technical documentation to meet MDR or IVDR requirements. However, the readiness and compliance of importers play a vital role in ensuring that medical devices are placed on the market in accordance with the regulations.
The results of Swissmedic’s inspections of 30 importers between March and September 2023, which revealed deficiencies at 23 of the inspected importers, clearly indicate that the transition phase for medical devices, is challenging for importers. To address these challenges effectively, importers should thoroughly evaluate their readiness by focusing on the following key areas:
1. Regulatory knowledge and awareness
- Importers should have a clear understanding of the MDR/IVDR’s requirements and changes compared to the previous Medical Device Directive (MDD/IVDD).
- Train employees appropriately and education about the MDR/IVDR.
- Develop a transition plan to align with MDR/IVDR requirements if previously operating under MDD/IVDD.
- Understand their responsibilities in cases where they also act as the authorized representative.
2. Labelling and UDI requirements
- Comply with new labeling requirements by indicating their name and address of the registered place of business and meet specific MDR/IVDR timelines.
- Comply with the Unique Device Identification (UDI) requirements to ensure that manufacturers have assigned a UDI.
3. Documentation
- Ensure an effective quality management system in place, in accordance with MDR/IVDR requirements.
- Importers must be ready to respond to any adverse events and complaints promptly and create the necessary processes as per the MDR/IVDR.
- Maintain accurate records of devices, quality, and safety information in compliance with MDR/IVDR requirements.
- Understand the different document requirements applying to different class of medical devices.
4. Supply chain
- Conduct risk assessments in line with MDR/IVDR requirements, especially for higher-risk devices.
- Ensure that their suppliers and manufacturers also meet MDR/IVDR requirements.
- Review and update agreements with manufacturers and suppliers to reflect MDR/IVDR obligations.
- Update the processes with regard to incoming goods inspection to ensure correct verification of the products according to the MDR/IVDR.