Question 6

As a Manufacturer (MFR), which obligations of the IVDR do I need to fulfil in order to place an IVDR compliant device on the market before the Date of Application (DoA) according to Art. 110 para 5 IVDR?

Answer

As many obligations as are possible, while taking into account that

  • EUDAMED may not be fully functional and
  • the IVDR is not fully applicable

at that point in time.

Generally speaking, that is to say that:

  • first, the device as such needs to be IVDR compliant (see Annex I IVDR) and
  • second, the MFR has to comply with the IVDR.

In particular, the MFR shall undertake an assessment of the conformity of that device in accordance with the applicable conformity assessment procedures set out in Art. 48 IVDR. This may, depending on the risk class of the device, necessitate the involvement of a notified body designated and notified in accordance with the IVDR (see Art. 110 para 6 IVDR).

The following requirements of the IVDR need to be fulfilled by the MFR (non-exhaustive list):

  • performance evaluation
  • risk management
  • QMS
  • Post-market surveillance
  • Technical documentation and other reports
  • Liability for defective devices

However, exceptions/adaptations are possible/necessary, particularly due to the fact that EUDAMED may not be fully functional before the DoA. For example:

  • in the absence of a fully functional EUDAMED some requirements of the Directive shall – where necessary - apply in place of the relevant provisions of the Regulation (e.g. registration of devices and economic operators).
  • A person responsible for regulatory compliance (PRRC, Art. 15 IVDR) needs to be available but not necessarily registered until EUDAMED is available.
  • The assignment of an UDI (Art. 24 para 3 IVDR) is not possible as long as there are
    • no issuing entities designated by the Commission according to Art. 24 para 2 IVDR and
    • as long as the legal fiction according to Art. 110 para 10 does not apply (it shall apply from 26 May 2019, see Art. 113 para 3 h IVDR).

    It is of no significant use as long as there is no UDI database.

Question 13

May MFRs of IVD devices not listed in Annex II of Directive 98/79/EC, that are compliant with the Directive, make use of the derogation in Art. 120 para 3 IVDR (= be placed on the market after the DoA)?

Answer

No, they must comply with the IVDR from the DoA. However, there is an exception with regard to devices for self-testing having a valid IVDD certificate. These devices may be placed on the market after DoA under the conditions specified in Art. 110 para 3 IVDR.

Question 14

May IVDD compliant devices, which under the IVDR will be subject to a “reclassification” in risk class (now a “rule-based classification system”), benefit from Art. 110 para 3 IVDR?

Answer

Yes, under the conditions specified in Art. 110 para 3 IVDR (e.g. valid IVDD certificate). Devices which are in a different - respectively higher - risk class in IVDR than under the Directive are not as such excluded from the scope of Art. 110 para 3 IVDR.

Question 15

What are the requirements for the placing on the market/putting into service of IVDD compliant devices according to Art. 110 para 3 IVDR after DoA?

Answer

In short:

  1. A valid IVDD certificate
  2. Continuous compliance of the device with the Directive
  3. No significant changes in the design and intended purpose. Qualification of a change as “significant” according to Art. 110 para 3 IVDR shall be determined on a case by case basis. However,
    • limitations of the intended purpose
    • design changes related to corrective actions assessed and accepted by the Competent Authority are not considered “significant” in the sense of Art. 110 para 3 IVDR.
  4. Application of IVDR requirements in place of the corresponding requirements of the Directives with regard to
  1. Registration of economic operators and of devices
  2. Post market surveillance (PMS) (without the PMS having to be an integral part of the QMS)
  3. Market surveillance (but device standards to be met = Directives)
  4. Vigilance

However, exceptions are possible in the case that EUDAMED is not fully functional in time.
Moreover, the “old” NB which issued the IVDD certificate shall continue to be responsible for the appropriate surveillance of all the applicable requirements relating to the devices it has certified. This should be agreed on between the “old” NB and the MFR on a contractual basis

MDR

Question 6

As a MFR, which obligations of the MDR do I need to fulfil in order to place a MDR compliant device on the market before the DoA according to Art. 120 para 5 MDR?

Answer

As many obligations as are possible, while taking into account that

  • EUDAMED may not be fully functional and
  • the MDR is not fully applicable

at that point in time.

Generally speaking, that is to say that:

  • first, the device as such needs to be MDR compliant (see Annex I MDR) and
  • second, the MFR has to comply with the MDR.

In particular, the MFR shall undertake an assessment of the conformity of that device in accordance with the applicable conformity assessment procedures set out in Art. 52 MDR. This may, depending on the risk class of the device, necessitate the involvement of a notified body designated and notified in accordance with the MDR (see Art. 120 para 6 MDR).

The following requirements of the MDR need to be fulfilled by the MFR (non-exhaustive list):

  • clinical evaluation
  • risk management
  • QMS
  • Post-market surveillance
  • Technical documentation and other reports
  • Liability for defective devices

However, exceptions/adaptations are possible/necessary, particularly due to the fact that EUDAMED may not be fully functional before the DoA. For example:

  • in the absence of a fully functional EUDAMED some requirements of the Directive shall – where necessary - apply in place of the relevant provisions of the Regulation (e.g. registration of devices and economic operators).
  • A person responsible for regulatory compliance (PRRC, Art. 15 MDR) needs to be available but not necessarily registered until EUDAMED is available.
  • The assignment of an UDI (Art. 27 para 3 MDR) is not possible as long as there are
    • no issuing entities designated by the Commission according to Art. 27 para 2 MDR or
    • as long as the legal fiction according to Art. 120 para 12 does not apply (it shall apply from 26 May 2019, see Art. 123 para 3 i MDR).
    It is of no significant use as long as there is no UDI database.
  • An implant card and the information according to Art. 18 MDR need to be provided, however without the UDI related content (as the requirement to place the UDI carrier on the devices will be stepwise introduced after the DoA).

Question 13

May MFRs of class I devices, that are compliant with the Directives, make use of the derogation in Art. 120 para 3 MDR (= be placed on the market after the DoA)?

Answer

No, they must comply with the MDR, unless the device concerned is a class I device with measurement function or in sterile condition covered by a valid MDD certificate.

Question 14

May devices that are excluded from the scope of the MDR (e.g. via Art. 1 para 6 lit h) nonetheless benefit from Art. 120 para 3 MDR?

Answer

No, these devices do not fall under the MDR, thus Art. 120 para 3 MDR is not applicable.

Question 15

May MDD/AIMDD compliant devices, which under the MDR will be subject to an “upgrade” in risk class (“up-classification”), e.g. formerly class IIa -> then class III, benefit from Art. 120 para 3 MDR?

Answer

Yes, under the conditions specified in Art. 120 para 3 MDR (e.g. valid AIMDD/MDD certificate). Devices which are in a different respectively higher risk class in MDR than under the Directives are not as such excluded from the scope of Art. 120 para 3 MDR.

Question 17

What are the requirements for the placing on the market/putting into service of MDD/AIMDD compliant devices according to Art. 120 para 3 MDR after DoA?

Answer

In short:

  1. A valid AIMDD/MDD certificate according to Art. 120 para 2 MDR [All certificates necessary for the placing on the market of the device in question need to be valid, e.g. a class III device needs to have a valid QMS as well as product specific certificate.]
  2. Continuous compliance of the device with the Directive
  3. No significant changes in the design and intended purpose. If there is a significant change in either the design or the intended purpose, Art. 120 para 3 MDR cannot be claimed. Qualification of a change as “significant” according to Art. 120 para 3 MDR shall be determined on a case by case basis. However,
    • limitations of the intended purpose
    • design changes related to corrective actions assessed and accepted by the Competent Authority are not considered “significant” in the sense of Art. 120 para 3 MDR.
  4. Application of MDR requirements in place of the corresponding requirements of the Directives with regard to:
    1. Registration of economic operators and of devices
    2. Post market surveillance (PMS) (without the PMS having to be an integral part of the QMS)
    3. Market surveillance (but device standards to be met = Directives)
    4. Vigilance

However, exceptions are possible in the case that EUDAMED is not fully functional in time.
Moreover, the “old” NB which issued the AIMDD/MDD certificate shall continue to be responsible for the appropriate surveillance of all the applicable requirements relating to the devices it has certified. This should be agreed on between the “old” NB and the MFR on a contractual basis

What does this mean to you?

This document can help you in better understanding some of the key transitional provisions of the IVDR and MDR. However, keep in mind that the documents are only intended to offer some insights, they are not legally binding nor, can they function as guidance tools.

Don’t hesitate to contact us for more information or for support in CE marking your products

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