MedTech Archive

Update: Mutual Recognition Agreement CH-EU

1) General background information

As a consequence of the failed MRA between CH and the EU, EU certificates (i.e., medicinal products with SQS certificate) which were issued by the respective Swiss body, shall no longer be recognized in the EU and an EU representative is required.

Swiss Medtech companies have recently engaged national associations in order to take action against the so-called SQS ban by the EU Commission.

Trade obstacles for MedTech companies due to the failed negotiations on the EU-Switzerland Institutional Agreement

Switzerland and the EU did not reach a consensus on the negotiations of the Institutional Framework Agreement. As a consequence, the Mutual Recognition Agreement (MRA) between the EU and Switzerland and related provisions for medical devices were not updated and, therefore, ceased to apply on 26 May 2021. With that, as of now Switzerland is considered as a ‘third country’ and Swiss MedTech companies lost their previously barrier-free access to the EU market and vice versa. The following article shows what companies selling medical devices need to consider when exporting to the EU or Switzerland.

Swiss established Medtech companies – action required for the sale of products in the EU. Is your business ready for the possible changes as per 26 May 2021?

Continue reading Swiss established Medtech companies – action required for the sale of products in the EU. Is your business ready for the possible changes as per 26 May 2021?

The impact of Brexit on Pharma, Life Science and MedTech companies – A PwC Pharma & Life Sciences Webinar

Dear pharma & life sciences colleagues

Brexit is coming closer every day with many aspects still unclear which makes it hard for you to prepare for it.

We’re excited to take a closer look at the current status quo and the impact of Brexit on indirect taxes, movement of goods and trade for Pharma, Life Sciences and MedTech Companies.

Pharma & Life Sciences: 4 cutting edge digital tax & regulatory solutions

Discover PwC’s four cutting edge digital tax & regulatory solutions and how they can add value to your business, help you complying with new laws, stay up to date with upcoming changes in legislation and regulatory.

Cutting edge tax implications for medical devices suppliers in Europe

Medical devices suppliers conducting agreements for allowing hospitals to use free of charge their equipment might face both VAT and corporate tax adverse implications.

Event: “Tax Engineering” für MedTech – 19. März 2020, PwC Luzern

Innovation gilt als Kernwert des Wirtschaftsstandorts Schweiz – und der MedTech-Branche. Das Volks-Ja zur Steuerreform hat der innovativen Tätigkeit von Unternehmen wie Ihrem eine neue Bedeutung verliehen. Auch andere nationale und internationale Neuerungen der indirekten Steuern und Zölle sowie neue regulatorische Rahmenbedingungen wirken sich 2020 auf die aktuelle und zukünftige Situation Ihres Unternehmens aus.

Wie daraus ein echter Mehrwert generiert werden kann, möchten wir gerne an unserem speziell der MedTech Branche gewidmeten Event mit Ihnen diskutieren.

Swiss Medtech companies – action required for the sale of products in the EU as per May 2020 – Is your business ready for the upcoming changes?

1. The background in a nutshell

Until 25th May 2020 all Medtech products that are admitted in Switzerland for the sale can be distributed also in the EU.
However, currently a new treaty is negotiated by Switzerland and the EU Joint Committee in that regard.
In case the treaty is not going to be concluded between Switzerland and the EU, all Medtech companies based in Switzerland are considered as not being anymore part of the EU. Indeed this treaty hangs by a hair.

Following the latest developments of the Swiss-EU negotiations concerning the Institutional Agreement and the Mutual Recognition Agreement (MRA), Swiss Medtech companies should be preparing for the case in which MRA would no longer apply to the medical devices after 26th May 2020.