Guidance on the key changes of classification rules under the European Medical Devices Regulation

MDD was first published in 1993 to harmonize the laws relating to medical devices within the European Union. The MDR came into force on 25 May 2017. The amendment to the MDR was published in April 2020, amending the MDR Date of Application to 26 May 2021. From 26 May 2021, it became compulsory for the new devices to meet the requirements of the MDR to be placed in the European market. MDR brings strict requirements with the intention to prove medical safety.

The European Union Medical Device Regulation has brought significant regulatory changes, including the changes in device classification. The total number of classification rules has increased from 18 to 22 and quite a few of the existing rules have been modified. As per the changes in the classification, the prerequisites for the manufacturers also change. The device manufacturers are required to review the updated classification rules and update their technical documentation accordingly.

The new MDR classifications react the potential risk of harm that a medical device poses. Class I devices are seen as the lowest risk whereas Class III are deemed high-risk devices. Moreover, there is a new class of high-risk software that has been introduced with the MDR. Importantly, this includes stand-alone software (software that can work online or is a portable application). For example, an app that helps users to calculate drug doses would be a Class III medical device because the potential errors involved pose high risks for the app’s users.

Under the new regulation, it is important to understand the EU MDR classification rules – particularly what classification your medical device falls under – and the rules surrounding the classifications.

MDR Device Classification:

Medical Device per EU MDR classification are classified in accordance with 4 risk groups as follows:

• Class I Medical Devices
• Class 1 Sterile
• Class 1 Measuring
• Class 1 Reusable
• Class IIa Medical Devices
• Class IIb Medical Devices
• Class III Medical Devices

Annex VIII of the MDR further categorizes devices as non-invasive, invasive, or active, or falling into another “specials rules” category for contraceptives, contact lens solutions, and device sterilizers.

It is imperative for the manufacturers to understand what classification your device falls under as per the new EU MDR rules. Regulatory experts at Saraca have extensive experience in classifying a range of medical devices and provide end to end assistance with MDR certification. Do leave a comment if you need detailed information on the new device classification rules.