Swiss Medtech Group, the non-governmental association that represents the interests of the companies operating within the medtech industry, issued recommendations to medical device manufacturers covering issues related to gaining access to various markets within the European Union. The new recommendations strive to help medical device manufacturers deal with any uncertainties with regulations which exist due to the Institutional Agreement between Switzerland and the European Union. The main idea of the recommendation is to help companies operating within the medtech industry fully grasp how to be prepared for  regulatory changes that could take place in the near future.

Compliance

If any medical device manufacturers from Switzerland are working  to distribute their products within the European market, they must comply with the regulatory requirements set by Medical Device Regulation, or EU 2017/745 MDR. This is the main act regulating the  approval process and post-selling support of any medical devices distributed in the European Union market. At the moment, the issues related to the approval and distribution are also regulated by the Mutual Recognition Agreement between Switzerland and European Union. According to the statement put out by the Swiss Medtech Group, the aforementioned agreement should be updated to improve the level of access to the market for manufacturers. d. Despite any upcoming  regulatory changes, all manufacturers will still need to comply with MDR requirements.

Regulatory requirements

The two main recommendations for  medical device manufacturers related to distribution in the European market are the following:

  1. To appoint a marketing representative in one of the countries of the European Union. This representative would act on behalf of the company representing it in relations with the regulating authorities during the whole marketing process. Such representations could be from the  submission of the initial application to maintaining any post-marketing obligations of the company including incident reporting, transmitting customers` feedback, inquiries upon the product to the manufacturer, etc.
  2. To adjust labeling according to the local requirements and also add information about the appointed representative entitled to act on behalf of the company, since labeling should bear information on authorised representative or importer.

 

The importance of the possible changes

According to the information stated in the recommendation of the Swiss Medtech Group, gaining compliance could take approximately two years depending on the number of the products and their complexity.

It is important to mention that the appointment of the local representative is quite a common requirement and it is widely spread among different jurisdictions. In most  cases, there are special companies that act as representatives for manufacturing companies where they have professional lawyers with broad experience in regulatory issues. At the same time, the company should pay additional attention to this issue to avoid the possible conflict of interest that could take place.

About RegDesk

RegDesk is always working on providing companies with the latest regulatory updates which could be important when looking to  distribute medical devices throughout Switzerland, or any other market. As Switzerland is one of the world leaders in the medtech industry, its market is very competitive. At the same time, the above average level of the general development of healthcare could be very intriguing to the manufacturers. With our state-of-the-art platform, RegDesk could aid you in any regulatory needs from addressing your pressing questions, to providing you with real time updates. Contact a representative today to gather more information to improve your regulatory platform!