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Home Blog What EU MDR changes mean to Manufacturers & what’s Next !


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WHAT EU MDR CHANGES MEAN TO MANUFACTURERS & WHAT’S NEXT !

February 17, 2023 ViSU


With EU MDR timelines extended, some brief analysis for manufacturers:

Devices benefitting

The extension provisions apply to a device if:

 * It was certified by a notified body under the Medical Device Directive
   93/42/EC (MDD) or the Directive on Active Implantable Medical Devices
   90/385/EEC (AIMD).
 * The MDD or AIMD certificate was valid at the date of application of the MDR
   (26 May 2021), and not later withdrawn (even if the certificate expired prior
   to the date of this new extension legislation).
 * Either: i) before the certificate expired the manufacturer and a notified
   body have signed a written agreement with a notified body for the conformity
   assessment 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.

Length of extension (excluding custom-made implantable devices)

 * 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.

What manufacturers should do

Manufacturers should make an application for 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.

Manufacturers with expired MDD/AIMD certificates or certificates likely to
expire in less than six months might consider applying for an Article 97
derogation now, in case the proposal does not become EU law in a shortened
timeframe.

Manufacturers with certificates that expire at least six – eight months from now
should keep a watching brief on the legislative process and if the proposal has
not become law at least six months before the due date for expiry of their
certificates, apply for an Article 97 derogation.

If the criteria for an Article 97 MDR application are not met, there is the
alternative of an Article 59(1) derogation application. These must be applied
for to each individual competent authority which will grant a derogation solely
in relation to their own country. However, if the purpose of the application is
simply to be able to take advantage of the extension in the proposal, only one
successful application is required. We can advise on the most amenable competent
authorities.

The Article 59(1) derogations require that the application is made ‘in the
interest of public health or patient safety or health’. Most competent
authorities are interpreting this narrowly by requiring that there are no
alternatives available on the market, and the fact that without the device,
patient health will be compromised. We have been successful in arguing that –
where competing devices are available – their supply volume is not sufficient to
meet demand. We have also successfully argued that – in a case where devices are
intended to operate with an installed base – it is not financially viable to
have hospitals change that installed base. Competent authorities are otherwise
generally immune to arguments about pricing or the necessity of competition on
the market.

Manufacturers should prioritize 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.

Tags:

EU MDRMedical Device DirectiveMedical Device ManufacturersMedical Device
Regualtion

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