Background Recap

As discussed in previous articles (see here and here), the EU Medical Devices Regulation[1] (MDR) comes into force on 26 May 2020, which will  revolutionise the medical devices regulatory regime. This will replace the outgoing EU Medical Devices Directive (MDD).[2]

Under the MDD, medical devices are categorised into four classes based on risk – Class I, IIa, IIb and III. Higher-class devices have a greater risk to the patient or user. Class IIa and above devices must be certified by a Notified Body (NB), in order to be placed on the market.

All of the medical devices certified under the MDD need to be re-certified under the MDR. Furthermore, many of the devices have moved up in class, so a device that may have fallen under Class I MDD, could now be Class IIa or above under the MDR.

Finally, only NBs with MDR Certification can certify medical devices under the MDR. Until this month, just three NBs have been certified under the MDR.

With the expected increased demand of MDR certified NBs, the current state of affairs have left many in the industry feeling nervous about a possible bottleneck for getting medical devices on the market.

A cause for optimism!

However, September has certainly been a promising month in the medical devices industry.

First of all, Novartis’ Concept1 inhaler was announced as the first medical device to be certified under the new MDR.[3] This device was previously a Class I device under the MDD so would not have needed NB approval. Under the MDR however, this device falls under Class IIa.

In further good news, the Istituto Italiano del Marchio di Qualità S.P.A. (IMQ) became the fourth NB approved under the MDR,[4] following in the footsteps of BSI Assurance UK Ltd, TÜV SÜD Product Service GmbH and DEKRA Certification GmbH.[5] Given the fact that BSI is based in the UK, and following Brexit will no longer be an EU NB; it is welcome news for industry manufacturers to have another NB on board to help deal with the inevitable flood of medical device certifications required.

The industry will be looking for many more NBs to become MDR certified (and devices to be certified) before feeling optimistic about the upheaval caused by the regulatory change, but September has seen some big steps in a positive direction.

[1] 2017/745

[2] 93/42/EEC

[3] As reported: https://www.raps.org/news-and-articles/news-articles/2019/9/novartis-inhaler-is-first-device-to-be-certified-u

[4] As reported: https://www.emergobyul.com/blog/2019/08/imq-becomes-fourth-notified-body-designated-mdr

[5] The Nando Database contains a list of the approved NBs.