9 May 2023
Medical Device Regulations – 1 of 3 Insights
The content of this article has been updated to reflect legal changes as at May 2023.
Further to the proposal discussed in our previous article (see Proposal for an extension of transition times for the EU MDR), the EU has now published the legislation that extends the transition period for Medical Device Directive 93/42/EC (MDD) certified legacy devices that are now regulated under the Medical Device Regulations 2017/745 (MDR). This is now therefore legally enforceable.
Given the continued capacity constrains in notified bodies, medical device companies should nevertheless continue to try to obtain their certificates at the earliest possible time.
The extension provisions apply to a device if:
i) Before the certificate expired the manufacturer and a notified body have signed a written agreement with a notified body for the conformity assessment under the MDR of the device or a device intended to substitute for the legacy device or
ii) A competent authority has granted an Article 59(1) or 97(1) derogation in respect of the device.
Note that Team Notified Body (NB) has a template letter that its members will issue upon application to confirm that there is a written agreement in place.
Once in force, devices benefiting from the extension of their certificates may be placed on the market or put into service until:
31 December 2027 - for class III devices and class IIb implantable devices sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
31 December 2028 - for all other devices, which are class IIb devices not included in a) above, class IIa devices, and class I devices that are placed on the market in a sterile condition or which have a measuring function.
Devices that are to be placed on the market or into service with the benefit of this extension must continue to meet the following conditions during the extension period:
Compliance with MDD/AIMD, as applicable.
No significant changes in design or intended purpose.
Don't present an unacceptable risk to the health or safety or patients, users or other persons, or to other aspects of the protection of public health.
By 26 May 2024 the manufacturer must have:
i) a QMS compliant with the MDR in place and
ii) applied to a notified body for a conformity assessment.
No later than 26 September 2024 NB and manufacturer have signed a written agreement for the conformity assessment (see template letter).
Class III custom-made implantable devices benefit from an extension to 26 May 2026 if:
By 26 May 2024 the formal application has been made with a notified body for a conformity assessment.
By 26 September 2024 the notified body and manufacturer have signed a written agreement in respect of that conformity assessment (see template letter).
Legacy devices that fit the criteria for the MDD/AIMD certificate extension will not require an Article 97 derogation to be able to stay on the market for the extension period, except if the written agreement with the notified body for the conformity assessment was not signed before the MDD/AIMD certificate expired. In this situation the manufacturer will need to apply for and obtain an Article 97 derogation, or alternatively an Article 59(1) derogation, in order to get the benefit of this legislation, assuming that all the other criteria are met.
Devices lawfully placed on the market under MDD or AIMD provisions, or under the extensions of the relevant certificates, might continue to be sold (made available) without limit in time.
Manufacturers should make an application for a derogation under Article 97 if their MDD/AIMD certificates have already expired and if in advance of that expiration, they did not already have a written agreement for a conformity assessment under the MDR with a notified body.
See our article, Article 97 derogations – help for manufacturers waiting for their MDR certificates, for an explanation on how to apply for a derogation under Article 97 MDR.
If the criteria for an Article 97 MDR application are not met, there is the alternative of an Article 59(1) derogation application, which is also explained in this article.
Manufacturers should prioritise placing devices subject to these provisions on the market in the EU/EEA ahead of the end dates for the extensions. Despite those end dates, if the 'placing on the market' step is achieved in advance, then the devices can continue to circulate on the market thereafter, subject to the devices' shelf-lives.
9 May 2023
8 December 2022
21 March 2023