New medical devices regulations: what they mean for researchers

Studies will need to be conducted to specific standards and collect particular types of data.

The Medicines & Healthcare Products Regulatory Agency (MHRA) has provided information on the new regulations on their website and the Joint Research Office has put together the following summary for investigators on the background to the new regulations and what they will mean.

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In 2017, the EU passed two new regulations:

· Medical Devices Regulation (MDR) EU 2017/745

· In Vitro Diagnostic Medical Devices (IVDR ) Regulation EU 2017/746

The MDR will fully apply from 26 May 2020, and the IVDR will fully apply from 26 May 2022.

The MHRA provides an abridged definition of a medical device as:

“any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings.”

In addition, it provides an abridged definition of an in vitro diagnostic medical device as:

“any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body.”

The new regulations are likely to cover entities such as biomarkers, regenerative medicine, software modifications to equipment, new implantable materials such as those for dental use and diagnostic kits.

While in the past there may have been requirements before such materials could be put on the market, the regulations now place specific requirements on how they can be “put into use”.

Under the new regulations, devices can be “put into use” in four ways – by being:

1. Put on the market having been approved by a notified body. Approval by a notified body could be based on evidence, either from a clinical investigation or from conformance or equivalence data depending on the class of device.

2. As the subject of a ‘clinical investigation’, i.e. an investigational entity in a trial

3. Used in a health care institution to meet the needs of a specific group

4. Custom-made for a specific individual.

The new regulations will not significantly change the current arrangements relating to point 1 above. The implications of the new regulations for points 2-4 are as follows:

Devices put into use by being the subject of a ‘clinical investigation’

Many more investigators and different types of research will now be regulated. Studies which use these devices will need to be conducted according to the ISO 14155 standard. There is considerable overlap between ISO 14155 and the Good Clinical Practice (GCP) standard. In addition, studies will need to comply with the requirements for the manufacture of the investigational entity which include the General Safety and Performance Regulations (GSPR) - Annex 1 of EU 2017/745.

Devices put into use by being used in a health care institution to meet the needs of a specific group

Health care institutions are exempt from some regulations if they manufacture and use the device for specific groups when no other devices for the purpose are available. But under the new regulations there are specific requirements and systems which need to be in place:

(a) The devices must not be transferred to another legal entity

(b) Manufacture and use of the devices must occur under appropriate quality management systems

(c) The General Safety and Performance Standards (GSPR) – Annex 1 of EU 2017/746 must be met

(d) The health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market.

Devices put into use by being custom-made for a specific individual

Under the new regulations, there is a different set of requirements for devices made for specific individuals. These requirements include:

· Compliance with General Safety and Performance Regulations (GSPR)

· Written prescriptions for individual patients from an authorised prescriber

· For class III devices a notified body may be required to authorise the device

· Vigilance reporting

· Periodic safety updates

· Specific documentation.

For more information please contact: uclh.randd@nhs.net.