Europe Overview

  Switzerland Overview

  United Kingdom Overview

There is extensive activity surrounding the IVDR’s date of implementation today.

Here we will discuss what is new, and the impact in the EU, Switzerland, and the UK.

Europe

For the purpose of this update, ‘Europe’ means the European Single Market, which includes the EU-27 member states, Iceland, Liechtenstein, Norway, Northern Ireland and Turkey.

Class A, non-sterile IVDs

The biggest impact today is on devices that were previously ‘other, self-certified’ under the old In Vitro Diagnostics Directive (IVDD), and are now ‘Class A, non-sterile, self-certified’ under the IVDR. These devices must comply with the IVDR in order to continue being placed onto the EU market. No transition period exists for these products.

Legacy Devices

Devices which were ‘other, self-certified’ under the IVDD, but are up-classed under the IVDR, are eligible for a transition period under the new IVDR progressive rollout. These devices are now ‘legacy’ devices, as are devices with Notified Body issued IVDD CE marking certificates.

Note that this only applies to devices that already had IVDD CE marking prior to the IVDR’s date of application. Any devices newly CE marked as of 26 May 2022 must comply with the IVDR, irrespective of the classification.

Legacy devices are subject to certain requirements under the IVDR, even though they are CE marked to the IVDD. These include requirements around:

• • market surveillance
  • post-market surveillance
  • vigilance
  • economic operator and device registration requirements

Regarding post-market surveillance, this includes development of a post-market performance follow-up (PMPF) plan and report.

Regarding vigilance, reporting of serious incidents and analysis of serious incidents and field safety corrective actions (FSCAs) will be per the IVDR.

Regarding registration of economic operators and devices, IVDR requirements will go into effect once EUDAMED is fully functional. In the meantime, industry should continue to follow the requirements outlined in the IVDD – this is the case even if the device is IVDR CE marked.

Not sure of your device’s classification under the IVDR? Help can be found in this guidance document: MDCG 2020-16 Rev.1

*This refers to devices already placed onto the market prior to the IVDR compliance date. The last column is the final date by which devices already on the market, may be available for sale.

New Guidance Documents released May 2022

The Medical Device Coordination Group (MDCG) released five IVDR-related guidance documents this month.

Legacy Devices

Casus already reported on these two guidance documents in detail:

MDCG 2022-6: IVDR Legacy Device Transition & Significant Changes

MDCG 2022-8: What aspects of the IVDR apply to legacy devices?

Summary of Safety and Performance

MDCG 2022-9: Summary of Safety and Performance Template

A Summary of Safety and Performance (SSP) is required for Class C and D IVDR CE marked devices.

It is not required for:

• • ‘legacy’ devices
  • Class A or B IVDR CE marked devices
  • Devices for performance studies

The audience for the SSP is the intended user of the device. Therefore, if the device is intended for self-testing, then the SSP should have information dedicated to the lay person end user, and if relevant, the patient. If the device is not intended for self-testing, then it should have a first part dedicated to the professional user and a second part dedicated to the patient/lay person.

The SSP is not intended to replace the Instructions for Use. It is “intended to provide public access to an up-to-date summary of the main aspects of the safety and performance of the device.”

The SSP will be validated by the notified body and made publicly available in EUDAMED, once EUDAMED is fully functional .

MDCG 2022-9 outlines the elements expected in an SSP, and acts as a template. i.e., it is an extremely useful resource for building your SSP.

The IVDR & Regulation 536/2014 on clinical trials for medicinal products for human use

MDCG 2022-10: Q&A document, covering the interoperability of databases for clinical trials with medicinal products and medical devices outlined in the Regulations.

This guidance has a narrow scope of applicability, but for those that may need this information, the guidance covers questions such as:

• In which situations may a non-CE marked IVD (or an IVD that is CE marked for another intended purpose) be used in a clinical trial for a medical purpose according to the IVDR?
• Is a use in research sufficient justification for an assay to be defined as Research Use Only (RUO)?
• Which IVDs should be listed in the cover letter of the clinical trial application?
• What are the notification/application requirements for the performance study according to the IVDR?

Please read the full 12-page guidance document if this information is applicable to you.

UDI under the MDR/IVDR

MDCG 2022-7: Q&A on the Unique Device Identification system under the MDR/IVDR

Like MDR CE marked devices, IVDR CE marked devices also require a Basic UDI-DI and a UDI system. This 13-page Q&A provides helpful clarification and is a recommended read.

Highlights from MDCG 2022-7 include:

• Where the number of items in a device package changes, is a new UDI-DI assignment required?
  • Answer*: Yes.
• Can a Declaration of Conformity (DoC) reference more than one Basic UDI-DI?
  • Answer: Yes.
• Are EU & US UDI requirements the same with respect to UDI labeling? Where a product is sold in the US and is compliant with the FDA UDI labeling requirements, can the same UDI product be used when placing a product on the market in the EU?
  • Answer: Generally, yes. However, some differences exist, such as the requirement of a Basic UDI-DI in Europe.
• Does a kit require its own UDI, or just the components of the kit?
  • Answer: Both the kit and the individual components require individual UDI.

For more information on Basic UDI-DI, please read: Your 2022 Guide to Basic UDI-DI

*Please review guidance for more comprehensive information. We have provided a short, summarized answer for informational purposes.

Bonus Guidance

The Irish Competent Authority’s May 2022 Newsletter includes a link to an IVDR webinar and the Q&A from that webinar.

More than 35 questions are answered, including:

• Q: The deadline for putting the UDI label on class D devices is May 2023. But what about the same class D, but for legacy devices?
  • A: Legacy devices are not required to have UDI-DI on the device label.
• Q: What documentation is required for IVD spare parts?
  • A: Article 20 of the IVDR calls out the requirements for parts and components. Spare parts or components must restore the function of the device without affecting its performance or safety. Documentation with evidence to this effect must be kept available for the Competent Authority

Switzerland

The Swiss IVD Ordinance (IvDO), which heavily references the IVDR, was adopted 4 May 2022 and is now published in the Federal Gazette. The IvDO is located: here

Swissmedic also published an update regarding the IvDO, confirming its publication and status of the lapsed Mutual Recognition Agreement (MRA) with Europe: here

The IvDO is mostly aligned with the IVDR. Where there are differences, it is generally related to the lapsed MRA.

For example, the IvDO lays down the requirements for a Swiss Authorized Representative, Swiss Importer and Swiss economic operator and device registration requirements, including the requirement for a Swiss Single Registration Number (CHRN).  An EU version of these are no longer recognized in Switzerland, and will not be until the issue of the MRA is resolved. However, the IvDO continues to reference the IVDR in relation to the requirements and obligations of the Swiss Authorized Representative and Importer.

The deadline to appoint a Switzerland Authorized Representative (CH-REP) under the IvDO is:

• • Class D: 31 December 2022
  • Class C & B: 31 March 2023
  • Class A: 31 July 2023

Note the above is for manufacturers already on the market. Manufacturers newly entering the EU/Swiss market must appoint a Swiss Authorized Representative immediately.

The CH-REP will notify Swissmedic of the appointment and must be identified on/with the manufacturer’s labeling.

Casus already covered the above topic in more detail: CONFIRMED – Switzerland adopts IvDO/IVDR

New & Updated Guidance Documents

The MDCG guidance documents referenced in the Europe section of this regulatory update, can also generally be applied to Switzerland. Note that differences related to the EU/Swiss Authorized Representative, Importers and registration of economic operators should be carefully assessed, to ensure Swiss requirements are being met.

To address the lapsed MRA, Swissmedic has also issued its own Information Sheets and webpage guidance. Those have been updated this month to reflect the IvDO/IVDR requirements.

Obligations for Authorized Representatives, Importers & Distributors

Information Sheet ‘MB Obligations Economic Operators CH’ has been updated to include IvDO/IVDR information.

Updates include:

• • IvDO transition deadlines, which follow the EU’s IVDR progressive rollout deadlines
  • Deadline to register devices:
    • IVDR devices placed on the market for the first time after 26 May 2022: within three months
    • IVDR devices that have been placed on the market prior to 26 May 2022: by 26 November 2022
    • IVDD devices placed on the market for the first time after 26 May 2022: within three months
    • IVDD devices that have been placed on the market prior to 26 May 2022: no obligation to register
  • Deadline to identify Swiss Authorized Representative:
    • IVDR products not for self-testing
      • On the labelling or in a document accompanying the device : until 31 March 2025
      • On the label: after 31 March 2025
    • IVDR self-test products
      • On the labeling as of 26 May 2022
    • IVDD devices that have already been placed on the EU/Swiss market
      • On the labeling, on the external packaging, in the instructions for use or in a document accompanying the device by:
        • Class D – 31 December 2022; Classes C and B – 31 March 2023; Class A – 31 July 2023
      • IVDD devices not previously placed on the EU/Swiss market
        • On the labeling, on the outer packaging, or in the instructions for use from 26 May 2022

Notification of IVDs

Swissmedic updated its webpage: Notification of IVDs

Registration Forms have been updated. As well, Swissmedic outlines the registration requirements for IVDR CE marked devices:

• • Class A sterile, B, C and D devices must be notified individually to Swissmedic
  • Class A non-sterile (‘self-certified’) devices can be notified individually or as device groups

This is only applicable to Swiss manufacturers. Swiss Authorized Reprensentatives (CH-REPs) are not obligated to notify IVD medical devices on behalf of third country (i.e., non-Swiss) manufacturers; however, the CH-REP is obligated to verify that the device complies with the Swiss medical device ordinance (IvDO). This is in line with Swiss medical device registration/notification requirements. 

See above section for registration deadlines.

Swiss Single Registration Number

Information Sheet ‘MB Swiss Single Registration Number – CHRN’ has been updated to require that Swiss-based IVD economic operators obtain a Swiss Single Registration Number.

The deadlines to obtain a CHRN are:

• • New to market: within three months of placing their first product on the Swiss market
  • Already on the market:
    • Class D – 31 December 2022
    • Class B & C – 31 March 2023
    • Class A – 31 July 2023

For more information, please read: What is a CHRN?

Performance Studies with IVDs

Swissmedic released Information Sheet ‘MB Performance Studies with IVD‘, which includes a decision tree to determine if your research project should be reported to Swissmedic.

United Kingdom

The United Kingdom is made up of two territories:

1. 1. Great Britain (England, Scotland, Wales)
   2. Northern Ireland

Great Britain

The IVDR has an indirect impact.

Great Britain currently allows manufacturers to register and place devices onto the market leveraging their European CE Marking, as a transition period allowance.

Therefore, if you registered an IVD with the MHRA as IVDD CE marked, and it is now IVDR CE marked, you must update your device registration accordingly. It should be updated to reflect the correct legislation; the new classification provided (e.g., from IVDD other, self-certified to IVDR Class A non-sterile); and the new Declaration of Conformity provided.

Great Britain manufacturers may complete the re-registration on their own. Non-Great Britain manufacturers must request their UK Responsible Person (UKRP) make this update on their behalf.

Great Britain will stop accepting CE marking as of 30 June 2023. After 1 July 2023, devices must be UKCA marked in order to continue being placed onto the Great Britain market.

Northern Ireland

Northern Ireland requires, and will continue to require, European CE Marking. Northern Ireland will not implement or recognize UKCA marking. This is part of the Northern Ireland Protocol, an agreement made between the UK and EU during ‘Brexit’ negotiations.

For more information, please read: Northern Ireland Medical Device Requirements and UKCA Marking