In this article we will go through Article 110 of EU IVDR 2017/746.
We have already been discussing about the requirements associated to legacy devices, specifically in the context of medical device and the related Article 120 of EU MDR 2017/745. The concept of legacy devices fully apples as well to in-vitro diagnostic devices and the related EU In-Vitro Diagnostic Device Regulation, EU IVDR 2017/746.
Article 110 of EU IVDR is basically defining the requrements for the transition period between the previous In-Vitro Diagnostic Directive 98/79/EC and the In-vitro Diagnostic Device Regulation 2017/746.
In this article we will go through the contents of Article 110 of the EU IVDR, talking as well about the guideline MDCG 2022-06 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR.
It is important to remind that EU IVD Regulation 2017/746 is effective from 26 May 2022; Certificates issued under the IVDD before the IVDR fully applies may remain valid for up to 2 additional years. However, starting from 26 May 2024, all devices placed on the market must be in conformity with the EU IVDR 2017/746.
Let’s go more in details about Article 110 of EU IVDR 2017/746.
Article 110 EU IVDR: Key Requirements
Similarly to the standard medical devices and the related Article 120, Article 110(3) of EU IVDR 2017/746 on in vitro diagnostic medical devices (IVDR) states that under certain conditions IVD devices may be placed on the market or put into service after the date of application of the IVDR, (26 May 2022), until the end of the different transition periods specified in Article 110(3) IVDR. The devices for which this rule s applicable are:
· devices which have a valid certificate issued by a notified body under the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), and
· devices for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with the IVDD and for which the conformity assessment procedure pursuant to the IVDR (contrary to the IVDD) requires the involvement of a notified body.
The first key concepts within Article 110 of the MDR is the validity of the certificates issued with the previous In-Vitro Diagnostic Device Directive and Active Implantable Medical Device Directive.
Basically, the article states:
Certificates issued by notified bodies in accordance with Directive 98/79/EC prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex VI to Directive 98/79/EC which shall become void at the latest on 27 May 2024.It is possible to sell the devices covered by CE certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC until the end of the validity period of the certificates. This is valid until 27 May 2024, after which it is mandatory to have on the market devices covered by certificates issued under the EU MDR or IVDR.
The concept of Significant Changes within Article 110of EU IVDR
Another key concept is related to changes allowed to be performed on the device in the transition period between the Directives 98/79/EC and the IVDR 2017/746. in fact, Article 110 of EU IVDR specifically states:
[….] a device with a certificate that was issued in accordance with Directive 98/79/EC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with that Directive, and provided there are no significant changes in the design and intended purpose.
In other words, for devices covered by certificates issued in accordance with the IVDD and, the certificate is valid the end of it period of validity unless significant changes are performed on the devices. In that case, re-certification under the IVDR shall be performed to place on the market .
We have extensively discussed about the process of change control and the concept of substantial changes for standard medical devices. Following Article 110, substantial changes are those modifications that are not allowed in the transition period for IVD devices covered by certificates issued under the IVDD. It is important to mention that QMS documentation shall be aligned with these requirements and the change control procedure shall include the requirements mentioned within MDCG 2022-06, that defines in details what can be considered substantial changes or not.
QualityMedDev has prepared a change control procedure specifically for IVD devices and fully aligned with Article 110 of the EU In-Vitro Diagnostic Regulation.
Post-Market Surveillance Activities
Article 110 MDR defines as well the requirements associated to post-market surveillance for legacy devices, thus devices covered by a certificate issued in accordance with the previous IVDD. In fact, for these devices, the article states the following:
[….] the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply and replace the corresponding requirements in that Directive.
This basically means that the requirements mentioned within Articles 78 and 87 of the EU IVDR 2017/746 shall be respected even for devices covered by a CE certificate issued under the previous IVD directives.
From practical standpoint, this means that all the devices currently on the market shall have:
- A post-market surveillance plan aligned with the requirements of Article 79 and Annex III.
- PMS Report (for class A and B devices) and PSUR (for devices of class C, and D).
- An effective vigilance system aligned with the requirements of Article 82.
- A system to keep monitoring post-market data, in alignment with Articles 83, 84 and 85 of the EU IVDR .
We have been discussing extensively about the post-market surveillance systems for medical devices, talking about PSUR, vigilance systems, ISO 20416, field safety notice and field safety corrective actions and in the coming weeks we are going to update these contents to make them aligned with EU IVDR 2017/746.
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