Practical last-minute solution for the labelling of medical products
On 17 December 2021 we informed you that – in the interests of the Swiss medical technology industry and patient care – Swiss Medtech was working with unwavering commitment on a more pragmatic solution for the labelling of medical devices. We are pleased to inform you that the Association has reached a suitable agreement with the FOPH (BAG) and Swissmedic authorities.
Medical devices under old legislation (MDD/AIMD products)
- MDD/AIMD products of all classes: The Swiss authorised representative (CH-REP) and importer may now, for example, also be listed on the delivery note / packing slip (a declaration directly on the product, packaging, or instructions for use is no longer obligatory).
Medical devices under new regulation (MDR products)
- MDR products of all classes: The Swiss authorised representative (CH-REP) must be indicated on the product or packaging (e.g. label). The importer may now, for example, also be listed on the delivery note / packing slip (a declaration directly on the product, packaging, or instructions for use is no longer obligatory).
- MDR Class I products: A transitional period until 31 July 2023 has been granted for the declaration of the Swiss authorised representative (CH-REP) on the product or packaging (e.g. label). Until then, such information declared on the delivery note / packing slip will likewise be accepted.
The Medical Devices Ordinance (MedDO) enforcement practices have been adapted accordingly. Please see Chapter 6 of Swissmedic's updated information sheet «Obligations Economic Operators CH».
The required specifications are essential for the rapid and precise identification of all responsible economic actors (CH-REP and importer) – for the purposes of market surveillance and patient safety, as well as the enforcement process (e.g. reporting of incidents, product recalls).
Recommended action points
- Ensure that foreign manufacturers appoint a CH-REP for all medical products they export to Switzerland before the end of the transitional periods (MepV Art. 104a).
- Ensure that in the case of MDD products, the CH-REP and the importer are indicated on the delivery note. We are aware that the effort to fulfil this requirement requires significant effort of your part – even if it is a one-time task.
- Ensure that the CH-REP is indicated on the product or packaging (e.g. label) of MDR products in accordance with the provisions of the MedDO. Ideally, as many foreign manufacturers as possible should be encouraged to indicate the CH-REP directly on the product labelling as part of the transition from MDD/AIMD to MDR.
This practical solution will help alleviate the impending supply problems. We would like to thank all those involved – and especially our members – who are doing their utmost to ensure the uninterrupted supply of quality-tested medical products to the Swiss population.
Swiss Medtech represents around 700 members in its role as industry association for Swiss medical technology. With 63,000 employees and a contribution of 16.4% to the positive trade balance, medical technology is an economically significant sector in Switzerland. Swiss Medtech advocates for conditions that enable the medtech industry to perform at peak capacity and provide first-class medical care.