IVDR Portal

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30 August 2022 – MDCG position paper regarding transition to MDR/IVDR

The Medical Devices Coordination Group (MDCG) has published an interesting position paper (MDCG 2022-14) outlining its position on a smooth transition aimed at avoiding disruptions in the supply of medical devices and ensuring access to the European market for innovative medical devices. The highlighted passages might help you in communicating with your notified body.

To the position paper

9 August 2022 – Position paper on MDCG documents

The Medical Devices Coordination Group (MDCG) uses guidance documents to assist stakeholders in implementing the medical devices regulations. With this paper MedTech Europe provides its view on how guidance documents should be used in a way that does not disrupt manufacturers’ efforts to transition to the new rules of the MDR and IVDR. MedTech Europe will now share the paper with the European Commission, the MDCG, the CAMD and the Notified Bodies. 

To the position paper

8 August 2022 – Swissmedic form for IVD products

Swissmedic has issued a form intended for the product registration of Swiss IVD manufacturers according to Art. 90 IvDO.

To the form (in German)

21 July 2022 – New EUDAMED information center launched

The European Commission has launched the new EUDAMED Information Center. It consolidates all EUDAMED Production User Guides, provides quick and structured access to all pertinent information and includes a contact form for users to reach the EUDAMED Support Team.

More information

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.

Revision of Swiss medical devices legislation

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. 

Notice European Commission

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.

Overview of IvDO: Dates and Deadlines

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.

Proposed amendment

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.

Statement (in german)

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).

More information

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.

More information

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.