If you are on the IVD business this article may help you a lot to understand what will happen after May 26th, 2022.
So today, we will mainly talk about Legacy Devices under the In-Vitro Diagnostic Legislation. This will help you a lot.
But First thing First. From May 26th, 2022 (Which is the Date of Application), the IVDR 2017/746 is the law. This means that you should apply it immediately. And when you read it, there will be some exceptions. But IVDR is the law. Below we will talk about all the impact of this on your company.
Table of Contents
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What is a Legacy Device?
You should know that when we talk about Legacy Devices, this means devices that are already on the market prior to the new regulation.
But instead of me telling you what this is, let’s copy what was written on the MDCG 2021-25 on Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC.
I know, this is not specific to IVDR but it is the same. The only difference is the date. So I will update it for you with the IVDR text. So let’s read that:
Legacy devices should be understood as devices, which, in accordance with Article 110(3) of the IVDR, are placed on the market after the IVDR’s date of application (DoA) and until 26 May 2024 if certain conditions are fulfilled. Those devices can be:
- devices which are Self-certified devices under Directive 98/79/EC (IVDD), for which an EC declaration of conformity was drawn up prior to 26 May 2022 and for which the conformity assessment procedure under the IVDR requires the involvement of a notified body;
I put in red what was modified just to be sure that you see the difference.
If your device is completely new to the EU market (A new launch of a new product) after May 26th, 2022, then this is not considered anymore as a Legacy device.
New Transitions per classification
End of 2021, the EU Commission submitted a proposal for changing the transition periods.
This change was related to classification. So normally the EU IVDR 2017/746 starts to be implemented by May 26th, 2022 but for each classification, there will be a period where the manufacturer can continue to sell the product following the previous legislation (If it is a legacy device).
Here are the dates:
- Class D devices: Until 26 May 2025
- Class C devices: Until 26 May 2026
- Class B devices: Until 26 May 2027
- Class A devices placed on the market in sterile condition: 26 May 2027
This means that the only devices that should follow IVDR fully from 26 May 2022 are all the class A devices.
For the others, if they are legacy devices and they are classified as class D, for example, the product can still be placed on the market following 98/79/EC until 26 May 2025.
During this transition, the Manufacturer should put in place a strategy as the challenge will be to obtain the certification from a Notified Body to continue under the IVDR.
The problem is the fact that there are really few Notified Bodies and they will be overloaded quickly. If you want to be on the safe side, your transition to EU IVDR should be quick.
Which IVD devices are considered Class A?
If you check in Annex VIII of the IVDR 2017/746, you will see that Rule 5 is describing the class A devices.
The following devices are classified as class A:(a) products for general laboratory use, accessories which possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination;(b) instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures;(c) specimen receptacles.
Procedures to update
Even if you have legacy devices, you should still update some procedures. All this is mentioned on Article 110. Let me show that to you.
By way of derogation from the first subparagraph of this paragraph, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to devices referred to in the second and third subparagraphs of this paragraph, instead of the corresponding requirements in Directive 98/79/EC.
So this means that even if you are under IVDD legacy devices, you still need to follow the requirements of IVDR for:
- Post-marketing Surveillance (Article 78)
- Market Surveillance (Article 88)
- Vigilance (Article 82)
- Registration of Economic Operators (Article 28)
So all these procedures should be updated and applied prior to May 26th, 2022 to be on the safe side.
Regarding the Registration of Economic Operators, this is something that is done through the EUDAMED database. As long as EUDAMED will not be fully implemented, the requirement will be voluntary, but I advise you to do it as this is quick and free. When this will become mandatory, you will have maybe more difficulty being registered as the review process is manual and not automatic.
Regarding the obligations, this is not finished. As said IVDR is the law, and the requirement to have a PRRC is also something that is important. So don’t forget to have your Person Responsible for Regulatory Compliance (Article 15)
Placing on the market
For companies that are not willing or cannot move to MDR, the concept of placing on the market will be important for them.
If you place your device on the market prior to the end of the Date of Application or the transition period, then this product can continue to be available on the market.
But if you are not compliant with the legislation after the Date of Application or the transition period, then your product cannot be placed on the market after the due date.
So some companies are building stocks prior to the due date and place these products on the market. This gives them a temporary period where their products are still available but they cannot place more.
If you want to understand more about the concept of placing on the market, read also the Blue Guide for CE marking.
See the video below talking about that for MDR, which is the same for IVDR.
There was also a podcast episode with Erik Vollebregt, a lawyer at Axon who talked about that: PODCAST
If you need any support for your projects under MDR, IVDR, ISO 13485, or other legislations please don’t hesitate to contact me.
Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don’t hesitate to contact him at firstname.lastname@example.org or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.