CAMD Publishes FAQs

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).

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.

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

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.

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