26 May 2022 – Entry into force of the IvDO and amendment of the ClinO-MD
On May 26, the new Ordinance on In Vitro Diagnostic Medical Devices (IvDO) and the amendment to the Ordinance on Clinical Trials with Medical Devices (ClinO-MD) entered into force. Analogous to the medical devices, an update of the MRA is also missing for in-vitro diagnostics, which is why Switzerland newly became a third country from the EU perspective. For economic actors in the IVD industry, this is accompanied by new requirements for product labeling and the appointment of authorized representatives.
25 May 2022 – Notice from the European Commission regarding the status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
The European Commission has published a notice to stakeholders on 24th May regarding the «Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices». There are no positive surprises. In the absence of an update of the MRA to include the IVDR, the part of the MRA chapter covering in vitro diagnostic medical devices ceases to apply as of 26 May 2022. This means that Swiss manufacturers of in vitro diagnostic medical devices will be treated as third country manufacturer and must designate an authorised representative established in the EU and label the products accordingly.
4 May 2022 – Publication of the IvDO
With just under a month to go before it comes into force, the Swiss authorities today adopted the new Regulation on In-vitro Diagnostics (IvDO), which is largely based on its European counterpart, the IVDR. The link below will take you to the text of the ordinance. Swiss Medtech will soon invite you to the next IVDR@noon webinar in order to critically evaluate the ordinance and discuss the most pressing questions.IvDO (in German)
22 February 2022 – Overview of IvDO: Dates and Deadlines
The IvDO will enter into force on 26 May this year - at the same time as the EU IVDR. The Swiss authorities have communicated the most important deadlines in this respect (subject to the decision of the Federal Council). For your information and orientation, Swiss Medtech has compiled these timelines in a chart.
23 December 2021 – The EU amendment to the IVDR regarding its transitional provisions is official
Ever since the EU Commission presented its proposal to amend the IVDR regarding the transitional provisions in mid-October, the industry has been eagerly awaiting and closely following the political decision-making process in the EU. The responsible political bodies (EU Parliament and Council) have both adopted the commission’s proposal, which means that the progressive roll-out of the IVDR has become official. While the IVDR will still enter into force in May 2022, the extended, risk-based transitional provisions address the lack of notified bodies in the European IVD ecosystem and will mitigate the risk of shortages in – for instance – Covid-19 tests. Swiss Medtech is in close contact with the relevant Swiss authorities and hopes that the transitional provisions in the IVDR will be reflected in the corresponding Swiss ordonnance, the IvDO.
18 October 2021 – EU Commission proposes amendment on IVDR introduction
In its statement of October 14, 2021, the EU Commission proposes to the European Parliament that the new IVDR be introduced gradually in order not to jeopardize the supply of in vitro diagnostics, which is indispensable – especially in the context of the Covid-19 pandemic. The Commission is not requesting any substantive changes to the regulation, but does provide for new, risk-based transition periods for legacy products. Class D and C products are to benefit from a transition period until May 2025 and May 2026, respectively. The transition period for Class B devices and sterile Class A devices is to last until May 2027.
1 July 2021 – Swiss Medtech and SVDI Statement regarding the IvDV and KlinV-Mep
Swiss Medtech and the SVDI firmly reject both draft regulations. The submitted versions are already out of date. Regarding medical devices, Switzerland has been relegated to third country status within the EU trade area since 26 May 2021. The current drafts are not at all applicable in this new reality. The Associations therefore call for a renewed public consultation and a fundamental revision – in the interest of the in-vitro diagnostics sector and the healthcare system as a whole.
27. Mai 2021 – Vernehmlassung zur neuen IvDV
Das Eidgenössische Departement des Inneren (EDI) hat am 14. April 2021 die Vernehmlassung zur neuen Verordnung über In-vitro-Diagnostika (IvDV) und den Anpassungen zur Verordnung über klinische Versuche mit Medizinprodukten (KlinV-Mep) mit Frist vom 14. Juli 2021 eröffnet. Die Stellungnahme von Swiss Medtech ist in Erarbeitung. Die neue Ausgangslage, namentlich der InstA-Abbruch-Entscheid des Bundesrates, wird dabei mitberücksichtigt. Wer Interesse hat, sich aktiv in die Erarbeitung der Vernehmlassungsantwort einzubringen, meldet sich bitte bei firstname.lastname@example.org.
25 January 2021 – MedTech Europe has updated the IVDR/MDR implementation tracker
This is a very helpful document as it shows you the state of EU documents and provides hyperlinks to directly access them. The document has two separate sections - one for published material and another for documents in the pipeline. We hope this structure helps you navigating throughout the document and get to the information you are looking for.
6 January 2021 – Publication of the expert names
The IVDR requires the European Commission to create expert panels to support the scientific assessment and advice in the field of vitro diagnostic medical devices. Amongst others, the panels of experts will provide an opinion on the notified bodies’ assessments of performance evaluation of certain in vitro diagnostic medical devices. The European Commission has published the names of the experts (voir le panel n° 12).
3 December 2020 – European Commission’s EUDAMED database
The European Commission’s EUDAMED database, a critical component of the MDR IVDR, was launched with the actor registration module. At present, economic operators established in the EU or European authorized representatives may register. Economic operators based in Switzerland will NOT be able to register until an agreement between Switzerland and the EU can be reached.
19 November 2020 – Harmonised standards under IVDR
A request for harmonisation of standards was submitted to the European Commission for adoption and submission to the European Committee for Standardization and the European Committee for Electrotechnical Standardization (CEN/CENELEC). Annex II contains a list of 45 existing and 3 new standards with deadlines for their adoption.
18 November 2020 – Guidance on the classification of in vitro diagnostics
The European Commission’s Medical Device Coordination Group (MDCG) has released its much-anticipated guidance on the classification of in vitro diagnostics under the IVDR. The 50-page guidance explains to manufacturers, notified bodies and healthcare providers how IVDs should be classified before they are placed on the EU market.