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

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• The MDD or AIMD certificate was valid at the date of application of the MDR (26 May 2021), and not later withdrawn (even if the certificate expired prior to the date of this new extension legislation).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.