We have already been discussing about the requirements associated to legacy devices, mentioning as well the existence of the Article 120 MDR, which basically regulates the transition period between the previous Medical Device Directive 93/42/EEC and the Medical Device Regulation 2017/745.
In this article we will go through the contents of Article 120 of the EU MDR and IVDR, talking as well about the guideline MDCG 2022-4 – Guidance on appropriate surveillance.
regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD, which defines the surveillance activities to be performed by notified bodies in the context of Article 120.
Let’s go more in details about Article 120.
Article 120 MDR: Key Requirements
The first key concepts within Article 120 of the MDR is the validity of the certificates issued with the previous Medical Device Directive and Active Implantable Medical Device Directive.
Basically, the article states:
Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however 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 120 MDR
Another key concept is related to changes allowed to be performed on the device in the transition period between the Directives 90/385/EEC and 93/42/EEC and the EU MDR 2017/745 and IVDR 2017/746. in fact, Article 120 MDR specifically states:
[….] a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC 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 either of those Directives, 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 MDD and AIMDD, the certificate is valid the end of it period of validity unless significant changes are performed on the devices. In that case, certification under the EU MDR / IVDR is mandatory.
We have extensively discussed about the process of change control and the concept of substantial changes that typically need to be communicated to the notified body. Following Article 120, substantial changes are those modifications that are not allowed in the transition period for devices covered by certificates issued under the MDD. 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 2020-03, that defines in details what can be considered substantial changes or not.
The Change Control Procedure in our 4EasyReg Shop is fully aligned with this requirements, does do not hesitate to download this documentation if you still did not update your QMS documentation with these rather new requirements.
Post-Market Surveillance Activities
Article 120 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 AIMDD and MDD. 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 in place of the corresponding requirements in those Directives.
This basically means that the requirements mentioned within Articles 83 and 90 of the EU MDR 2017/745 must be respected even for devices covered by a CE certificate issued under the previous medical device 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 84 and Annex III.
- PMS Report (for class I devices) and PSUR (for devices of class IIa, IIb and III).
- An effective vigilance system aligned with the requirements of Article 87.
- A system to keep monitoring post-market data, in alignment with Articles 88 and 89 of the EU MDR .
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 .
MDCG 2022-04: Surveillance Activities related to Article 120
Medical Device Co-ordination Group recently published a new guideline related to the surveillance activities to be performed by notified bodies in relation to legacy devices and Article 120 MDR. We are not going in details of this guideline (MDCG 2022-04), however we are going to highlight some topics related to obligations of the manufacturers that it is possible to deduce from this guideline.
First of all, as confirmation of what we have been discussing before, the guideline mentions:
all relevant requirements set out in Chapter VII MDR on post-market surveillance, market surveillance, vigilance and registration of economic operators and of devices apply to ‘legacy devices’ in place of the corresponding requirements in the Directives.
For this reason, QMS of the manufacturers shall be updated to include, for example:
- Transition Plan between MDD and MDR;
- Change Management aligned with Article 120 and MDCG 2020-03;
- QMS procedures updated to include the new requirements related to post-market surveillance.
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