Latest News in Medical Technology: FDA Approval, swissdamed, and the Countdown to Swiss Medtech Day
02/05/2024
True, existing regulatory requirements provide sufficient material for our team’s in-depth discussions with manufacturers and other medical technology stakeholders. In this article, however, we would like to give you a brief insight into the additional topics that are currently in the pipeline and will keep us and our customers busy in the coming months: The recognition of FDA approval for medical devices in Switzerland, the introduction of swissdamed - and preparations for Swiss Medtech Day in Bern.Recognition of FDA Approval in Switzerland
In November 2022, the Swiss parliament decided that medical devices which meet the requirements of non-European regulatory systems should also be authorized in Switzerland in future to ensure the security of supply - and not just products with the European CE mark, as was previously the case. This primarily concerns the recognition of US FDA approval of medical devices for use in Switzerland.Swiss Medtech has also taken a clear position on this, calling for the decision to be implemented swiftly and pragmatically. The ball is now in the Swiss Federal Council’s court for implementation until November 2024 (the two-year deadline of the decision), although it has not yet published a draft bill or provided any other information on its planned approach. Developments in the coming months remain exciting.Introduction of swissdamed
Another important development is the introduction of swissdamed, the database for medical devices in Switzerland (Swiss Database on Medical Devices). In connection with the lack of an update to Chapter 4 (medical devices) of the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (MRA, SR 0.946.526.81), the registration of economic operators and medical devices and in vitro diagnostics (IVDs) will now take place directly with Swissmedic and not with the European Union.As things stand, swissdamed will be launched in the second half of 2024, which is later than originally planned; according to Swissmedic, this is due to the integration into the Swissmedic Cloud, which will take some time.Note: After the publication of this article, the swissdamed "Actors Module" went live on August 6, 2024, and is now available for registration.A glance at the EU: News from MDR and IVDR
Speaking of security of supply and delays in the introduction of the database: These issues are currently relevant not only in Switzerland but also in the European Union. Just like swissdamed, its EU counterpart EUDAMED (European database on medical devices) is struggling with delays in implementation – and shortages in patient care are also feared in the EU due to the introduction of the MDR (Medical Device Regulation (EU) 2017/745) and especially the IVDR (In Vitro Diagnostic Medical Device Regulation (EU) 2017/746).Therefore, on January 23, 2024, the European Commission proposed a series of measures to ensure the security of supply of medical devices and IVDs in the European Union. On April 25, 2024, the European Parliament approved these measures, which will enter into force on the date of their publication in the Official Journal of the European Union after formal adoption of the amending Regulation by the European Council. Of course this will also have implications for the sale of Swiss medical products in the European Union and the sale of products from EU manufacturers in Switzerland.Our colleague Dr. Otmar Lienhart has dealt with the proposed changes in his blog post on the EU proposal.Swiss Medtech Day 2024
We do not want to hide the fact that we are waiting impatiently for Swiss Medtech Day on June 11, 2024, in Bern. Why? Because it offers the opportunity to engage in discussions with a wide range of manufacturers and regulatory experts from Switzerland. This is the best way for us to find out what manufacturers are concerned with most.It is much more important for us to have a direct exchange about current developments and challenges in the industry on such occasions than to talk about our own offerings. We are very much looking forward to this great opportunity coming upt in less than two months.What can we do for you?
Do you have questions about international approval or other regulatory challenges and don't want to wait until Swiss Medtech Day to get in touch with us? Then send us a message and we will get in touch with you – no strings attached. No matter what your concern is: We look forward to hearing from you!
Recognition of FDA Approval in Switzerland
In November 2022, the Swiss parliament decided that medical devices which meet the requirements of non-European regulatory systems should also be authorized in Switzerland in future to ensure the security of supply - and not just products with the European CE mark, as was previously the case. This primarily concerns the recognition of US FDA approval of medical devices for use in Switzerland.Swiss Medtech has also taken a clear position on this, calling for the decision to be implemented swiftly and pragmatically. The ball is now in the Swiss Federal Council’s court for implementation until November 2024 (the two-year deadline of the decision), although it has not yet published a draft bill or provided any other information on its planned approach. Developments in the coming months remain exciting.Introduction of swissdamed
Another important development is the introduction of swissdamed, the database for medical devices in Switzerland (Swiss Database on Medical Devices). In connection with the lack of an update to Chapter 4 (medical devices) of the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (MRA, SR 0.946.526.81), the registration of economic operators and medical devices and in vitro diagnostics (IVDs) will now take place directly with Swissmedic and not with the European Union.As things stand, swissdamed will be launched in the second half of 2024, which is later than originally planned; according to Swissmedic, this is due to the integration into the Swissmedic Cloud, which will take some time.Note: After the publication of this article, the swissdamed "Actors Module" went live on August 6, 2024, and is now available for registration.A glance at the EU: News from MDR and IVDR
Speaking of security of supply and delays in the introduction of the database: These issues are currently relevant not only in Switzerland but also in the European Union. Just like swissdamed, its EU counterpart EUDAMED (European database on medical devices) is struggling with delays in implementation – and shortages in patient care are also feared in the EU due to the introduction of the MDR (Medical Device Regulation (EU) 2017/745) and especially the IVDR (In Vitro Diagnostic Medical Device Regulation (EU) 2017/746).Therefore, on January 23, 2024, the European Commission proposed a series of measures to ensure the security of supply of medical devices and IVDs in the European Union. On April 25, 2024, the European Parliament approved these measures, which will enter into force on the date of their publication in the Official Journal of the European Union after formal adoption of the amending Regulation by the European Council. Of course this will also have implications for the sale of Swiss medical products in the European Union and the sale of products from EU manufacturers in Switzerland.Our colleague Dr. Otmar Lienhart has dealt with the proposed changes in his blog post on the EU proposal.Swiss Medtech Day 2024
We do not want to hide the fact that we are waiting impatiently for Swiss Medtech Day on June 11, 2024, in Bern. Why? Because it offers the opportunity to engage in discussions with a wide range of manufacturers and regulatory experts from Switzerland. This is the best way for us to find out what manufacturers are concerned with most.It is much more important for us to have a direct exchange about current developments and challenges in the industry on such occasions than to talk about our own offerings. We are very much looking forward to this great opportunity coming upt in less than two months.What can we do for you?
Do you have questions about international approval or other regulatory challenges and don't want to wait until Swiss Medtech Day to get in touch with us? Then send us a message and we will get in touch with you – no strings attached. No matter what your concern is: We look forward to hearing from you! |  | |
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