MDR Transitional Periods
In Article 120, the MDR establishes its transitional provisions, including the transitional periods.
However, the descriptions of these transitional provisions and transitional periods are worded in a very complex manner. As a result, manufacturers are at risk of misunderstanding them and therefore not complying with regulatory requirements or incurring unnecessary costs.
A flow chart at the end of this article summarizes the regulatory requirements and provides clarity. It is also available as a free download
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1. Transitional periods in the MDR: introduction
The discussion regarding transitional periods is usually limited to the question of how long a product can be placed on the market. As a result, the MDR has a number of transitional periods.
Manufacturers need, for example, to differentiate between the following aspects with regard to transitional periods:
- Placing on the market of new and legacy devices
- Making devices available and putting them into service
- OEM-PLM setup
- “Person responsible for regulatory compliance”
- Post-market surveillance
- Vigilance
- QM system
- UDI
- Clinical investigations
This article provides an overview of these transitional periods. Readers in a hurry can skip straight to the summary.
2. Transitional periods: MDR article
a) MDR, Article 120(2)
Original text
Article 120 is entitled “Transitional provisions”. It also mentions the transitional periods. The second paragraph is particularly relevant:
"Bescheinigungen, die von Benannten Stellen vor dem 25. Mai 2017 gemäß den Richtlinien 90/385/EWG und 93/42/EWG ausgestellt wurden, bleiben bis zu dem in der Bescheinigung angegebenen Zeitpunkt gültig, außer im Fall von Bescheinigungen gemäß Anhang 4 der Richtlinie 90/385/EWG bzw. gemäß Anhang IV der Richtlinie 93/42/EWG, die spätestens am 27. Mai 2022 ihre Gültigkeit verlieren."
"Bescheinigungen, die von Benannten Stellen nach dem 25. Mai 2017 gemäß den Richtlinien 90/385/EWG und 93/42/EWG ausgestellt werden, behalten ihre Gültigkeit bis zum Ende des darin angegebenen Zeitraums, der fünf Jahre ab der Ausstellung nicht überschreiten darf. Sie verlieren jedoch spätestens am 27. Mai 2024 ihre Gültigkeit."
MDR Article 120(2)
Interpretation of this text
If the manufacturer has a current “authorization”, this remains valid for the time being. However, the certificate must have been issued by the notified bodies on or after May 25, 2017. Furthermore, they become void on May 27, 2022[A1] , even if the validity date specified on the certificate is after May 27, 2022.
Because certificates can only be issued by notified bodies and only for class I*, IIa, IIb and III devices, the second paragraph of Article 120 does not apply to class I devices.
These certificates must be obtained before a device is placed on the market, as detailed in Article 120(3) of the MDR.
b) MDR, Article 120(3)
Original text
The second erratum changes the middle, third paragraph of Article 120. This now reads as follows:
"Abweichend von Artikel 5 der vorliegenden Verordnung darf ein Produkt, das ein Produkt der Klasse I gemäß der Richtlinie 93/42/EWG ist, für das vor dem 26. Mai 2020 eine EU-Konformitätserklärung erstellt wurde und für das das Konformitätsbewertungsverfahren gemäß der vorliegenden Verordnung die Mitwirkung einer Benannten Stelle erfordert oder für das eine Bescheinigung gemäß der Richtlinie 90/385/EWG oder der Richtlinie 93/42/EWG besteht, die gemäß Absatz 2 des vorliegenden Artikels gültig ist, bis zum 26. Mai 2024 in Verkehr gebracht oder in Betrieb genommen werden, sofern es ab dem 26. Mai 2020 weiterhin einer dieser Richtlinien entspricht und sofern keine wesentlichen Änderungen der Auslegung und der Zweckbestimmung vorliegen. Die Anforderungen der vorliegenden Verordnung an die Überwachung nach dem Inverkehrbringen, die Marktüberwachung, die Vigilanz, die Registrierung von Wirtschaftsakteuren und von Produkten gelten jedoch anstelle der entsprechenden Anforderungen der genannten Richtlinien."
MDR Article 120(3)
Readability index for this text
The text is admittedly very difficult to understand, as is confirmed by its readability index. This value is normally between 20 (youth literature) and 60 (specialist literature). The readability index of this section is 106, which is off the indicator scale of a lot of tools (see Figure 1).
[A1]The translation team has come to us with the following question: “Should this be May 27, 2024 in line with the second paragraph of 120(2)?”
Interpretation of this text
The third paragraph of Article 120 can be interpreted as follows:
From May 25, 2020 manufacturers may only place devices on the market in accordance with the requirements of the MDR, unless one of the following exemptions applies:
- The manufacturer has a valid certificate for the device. As described in the comments on paragraph 2, this can only apply to devices in the (former) classes I*, IIa, IIb and III.
- The manufacturer placed a class I (MDD) device on the market before May 26, 2020 and the device would fall into one of classes I*, IIa, IIb or III. This would be the case, for example, with reusable surgical instruments and devices that would be considered “Software as Medical Device”.
However, these exemptions only apply under these conditions:
- The device still complies with the requirements of the MDD and/or AIMD.
- The manufacturer has not made any significant changes to the device.
Furthermore, the following restrictions apply to the exemptions:
- The exemptions end on April 26, 2024 at the latest.
- The exemptions do not affect the post-market surveillance, market surveillance, vigilance or the registration of economic operators and devices.
Further information
The question of how big changes can be before they have to be considered “significant” is a major source of discussion. Please see the articles on design changes and software changes for more information on this.
You should also pay attention to the information published by NAKI [German National Working Group] on the matter:
Restrictions on intended purpose
Changes to design due to a corrective action that has been evaluated and accepted as such by the competent authorities are not considered “significant” changes according to Art. 120, para. 3 MDR.
NAKI FAQ, response to question 17
c) MDR, Article 120(4)
Original text
The fourth paragraph is, by comparison, easy to understand:
“(4) Produkte, die vor dem 26. Mai 2020 gemäß den Richtlinien 90/385/EWG und 93/42/EWG rechtmäßig in Verkehr gebracht wurden, und Produkte, die ab dem 26. Mai 2020 gemäß Absatz 3 des vorliegenden Artikels in Verkehr gebracht wurden, können bis zum 26. Mai 2025 weiter auf dem Markt bereitgestellt oder in Betrieb genommen werden.”
MDR Article 120(4)
Interpretation of the text
The following devices may be made available on the market or put into service until May 26, 2025:
- All devices placed on the market in compliance with the law before May 26, 2020.
- All devices that benefit from one of the exemptions established in paragraph 3.
The question of when a device can be considered “placed on the market” is open to discussion. This is especially true for standalone software.
Please read the article on placing on the market for more information regarding this.
d) MDR, Article 120(8)
Paragraph 8 simply causes a lot of people to shake their heads. Who is supposed to understand this on first reading?
“(8) Abweichend von Artikel 10a, Artikel 10b Absatz 1 Buchstabe a und Artikel 11 Absatz 5 der Richtlinie 90/385/EWG und von Artikel 14 Absätze 1 und 2, Artikel 14a Absatz 1 Buchstaben a und b und Artikel 16 Absatz 5 der Richtlinie 93/42/EWG wird angenommen, dass Hersteller, Bevollmächtigte, Importeure und Benannte Stellen, die im Zeitraum, der am späteren der in Artikel 123 Absatz 3 Buchstabe d genannten Daten beginnt und 18 Monate später endet, Artikel 29 Absatz 4, Artikel 31 Absatz 1 und Artikel 56 Absatz 5 der vorliegenden Verordnung genügen, die Vorschriften und Bestimmungen erfüllen, die die Mitgliedstaaten nach Maßgabe des Beschlusses 2010/227/EU gemäß Artikel 10a der Richtlinie 90/385/EWG bzw. gemäß Artikel 14 Absätze 1 und 2 der Richtlinie 93/42/EWG, gemäß Artikel 10b Absatz 1 Buchstabe a der Richtlinie 90/385/EWG bzw. gemäß Artikel 14a Absatz 1 Buchstaben a und b der Richtlinie 93/42/EWG sowie gemäß Artikel 11 Absatz 5 der Richtlinie 90/385/EWG bzw. gemäß Artikel 16 Absatz 5 der Richtlinie 93/42/EWG erlassen haben.”
MDR Article 120(8)
Interpretation of the text
With regard to EUDAMED, the MDR has established the following requirements:
- Manufacturers must register custom-made devices in EUDAMED (Article 29(4)).
- Economic operators must register themselves in EUDAMED (Article 31(1)).
- The notified bodies must enter the certificates in EUDAMED (Article 56(5)).
The authors of the MDR expect member states to adopt more precise regulations (laws, national ordinances) in this context that the economic actors will also comply with. In other words, the corresponding provisions of the EU directives, i.e., the AIMDD and the MDD no longer apply.
However, this obligation refers to the “period starting on the later of the dates referred to point (d) of Article 123(3) and ending 18 months later”.
This point d) contains the following information:
- May 25, 2020 (start of validity of the MDR)
- The day six months after the date of publication of the notice referred to in Article 34(3). This article refers to publication in the Official Journal of the news that EUDAMED is fully functional.
This means that manufacturers, with regard to EUDAMED and registration in the 18 month periods, “only” have to comply with the above obligations. After that, the requirements of the MDR apply.
For those of you who want to understand paragraph 8 in more detail, these are the references it contains:
- AIMDD (90/385/EEC)
- Article 10a: Manufacturer registration
- Article 10b(1)(a): Certificates in database
- Article 11(5): Certificates issued and withdrawn by notified bodies
- MDD (93/42/EEC)
- Articles 14(1) and 14(2): Registration of persons responsible for placing devices on the market
- Article 14a(1)(a) and (b): European database (manufacturers, authorized representatives, certificates)
- Article 16(5): Certificates issued and withdrawn by notified bodies
e) MDR Article 123 (“Entry into force and date of application”)
Article 123 specifies other time limits that affect economic operators, e.g.:
- Paragraph (2)(d): This lists all obligations that must be complied with, in the context of EUDAMED, at the latest six months after the date of the notice that EUDAMED is fully functional. In contrast to Article 120(8), this does not relate to transitional provisions for old devices.
- Paragraph (2)(e): For the registration of devices and the entering of certificates in EUDAMED, the MDR even grants 18 months’ grace from the date that EUDAMED is declared fully functional.
For class III devices, the UDI must be placed on the device by May 26, 2021, for class IIa and IIb devices from May 26, 2023 and for class I devices from May 26, 2025.
3. Other regulatory requirements
Please also pay attention to the following documents that are relevant for regulatory purposes:
- MDCG 2019-4 Timelines for registration of device data elements in EUDAMED
- Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC
- MDCG 2019-15 GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
- NAKI FAQs on transitional provisions in the MDR
For example, the NAKI FAQs confirm:
- There is no transitional period for the person responsible for regulatory compliance.
- With regard to the implant card and information that must be provided to patients with an implanted device according to Art. 18 MDR, the content relating to the UDI can be omitted, provided that there is no UDI marking obligation for the device in question.
- The possibility of making available/putting into service of devices already (first) placed on the market prior to May 26, 2020 is not time limited by Article 120(4) MDR. This is the so-called “clearance regulation”.
- A declaration of conformity cannot be considered a “certificate” as defined by Art. 120(2) MDR, as it is issued by the manufacturer itself and not a notified body.
- There are no transitional periods for post-market surveillance and vigilance obligations, or the registration of economic operators.
N.B!
Please note that some guidelines and FAQs are now out of date in some respects. For example, the response to question 13 in the NACI FAQs, which is no longer generally applicable.
4. Summary and conclusion
a) Overview of the transitional periods
Aspect | Transitional period | Comment |
First placing on the market of devices | May 26, 2020 | |
Placing of legacy devices on the market | See flow chart below | |
Making available of devices | See flow chart below | |
Putting into service of devices | See flow chart below | |
OEM-PLM setup | The same transitional periods apply for these devices | |
“Person responsible for regulatory compliance” | May 26, 2020 | With restrictions regarding registration in EUDAMED |
Post-market surveillance | May 26, 2020 | With restrictions regarding EUDAMED |
Vigilance | May 26, 2020 | With restrictions regarding EUDAMED |
QM system | For new devices and for the above processes, such as PMS, May 26, 2020 | For devices already placed on the market, conformity with Annex IX is not required during the transitional period. |
UDI | See table below | |
Clinical investigations | May 26, 2020 | Investigations that have been started may be continued, but new reporting requirements apply |
Article 10 of the MDR does not apply to devices that benefit from the transitional period. The above requirements regarding post-market surveillance and vigilance, among others, are excluded from this.
b) Placing on the market, making available and putting into service
How long manufacturers can still place their existing devices on the market, make them available or put them (or have them put) into service depends, among other things, on the class of the device and the validity of any certificates.
c) EUDAMED, registration
First 6 months after publication | The next 18 months after that | Subsequently | |
Legacy devices | No requirements | Only registration of custom-made devices (Article 29(4)), registration of economic operators (Article 31(1)) and certificates (Article 56(5)) and requirements of the directives | All requirements |
New devices | No requirements | All requirements except registration of custom-made devices (Article 29(4)) and certificates (Article 56(5)) | All requirements |
d) Transitional periods for the UDI
The date from which the UDI must be applied depends on the class of the device:
Class | Time |
I | May 26, 2025 |
IIa | May 26, 2023 |
IIb | May 26, 2023 |
III | May 26, 2021 |
For reusable devices where the UDI has to be placed on the device itself, the MDR grants two additional years.
e) Conclusion
The EU certainly does not help itself with texts like paragraph 8 of Article 120. There should be rules that stipulate that it must also be possible for non-lawyers to read and understand regulations. The readability index is one metric it could use.
Manufacturers must also be aware that they will have to comply with a lot of MDR requirements without any transitional periods, even if they do not want to place new devices on the market and do benefit from the transitional periods according to Articles 120(2) and (3).
In some cases, the notified bodies will check conformity with these requirements even before the audit. They can then reject surveillance and re-certifications if these requirements are not fulfilled.
Author:
Prof. Dr. Christian Johner
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