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.
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.
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.
|IVDR Classification||IVDR Compliance Date||Can Be Made Available Until*|
|Class D||26 May 2025||26 May 2026|
|Class C||26 May 2026||26 May 2027|
|Class B||26 May 2027||26 May 2028|
|Class A, sterile||26 May 2027||26 May 2028|
|Class A, non-sterile||26 May 2022||26 May 2025|
|IVDD NB CE Certificates||26 May 2025||26 May 2025|
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:
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.
The Medical Device Coordination Group (MDCG) released five IVDR-related guidance documents this month.
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:
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:
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:
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.
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:
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:
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
Casus can act as your Swiss Authorized Representative (CH-REP). Read about our service here.
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.
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:
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:
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.
The United Kingdom is made up of two territories:
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.
Casus can act as your UK Responsible Person (UKRP). Read more about our service here.
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.
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