Overdosing on a few medicines can have disastrous repercussions on the human body. Many manufacturers are working to develop drug monitoring systems that can detect a patient’s drug levels in the bloodstream and further adjust treatment and dosages to avoid potentially disastrous outcomes. By definition, a drug monitoring device usually measures the number of specific drug concentrations in plasma, serum, or blood. This information is used to personalize the dosage prescribed to the patient so that drug concentrations can be maintained within a target range.

A medical device company manufacturing a drug monitoring device approached Elexes with the intention of gaining regulatory assistance. The manufacturer was based outside the UK and wanted to enter the UK market to cater to new customers. However, they were unsure of how to begin this journey and what should be done to achieve authorization to legally sell within the UK.

The Problem:

The company desired to identify appropriate device classification per UK medical device regulations, and understand the steps that needed to be followed per the applicable regulatory pathway based on the device’s intended use.

Approach and Solution:

Elexes performed extensive regulatory due diligence based on the device’s intended use and the following were determined to be the steps involved in introducing the product into the UK market.

Determination of an IVD

Identify whether the device is intended to be used as an In Vitro Diagnostic as per the definition put forth in UK MDR 2002 PART IV.

Determination of the IVD device category

As per UK MDR 2002 part IV, the IVD devices have been classified into 4 different categories.

a) General IVDs

b) IVDs for self-testing

c) List B IVDs: Reagents products for rubella, toxoplasmosis and phenylketonuria (among others), as well as devices for self-testing for blood sugar

d) List A IVDs: Reagents and products for HIV I and II, hepatitis B, C and D, as well as reagent products for determining blood groups and anti-Kell, including those used to test donated blood, plus tests for screening Variant Creutzfeldt–Jakob disease.

Registration with the MHRA

The manufacturer should register the devices with the MHRA by providing the device & manufacturer’s specific information prior to getting their products on the market.

Conformity assessment routes for General IVD Device

The manufacturer must fulfill the requirements mentioned in sections 2 to 5 of Annex III, Part IV of UK MDR 2002. General IVD can be self-certified; no UK-approved body involvement is required.

Affixing the UKCA Mark

After completing the conformity assessment and providing the Declaration of Conformity, the manufacturers can affix the UKCA marking on their devices.

As per UK MDR 2002 and DIRECTIVE 98/79/EC, this device falls under the General IVD classification. As it falls under this category, the device manufacturer should register the devices with the MHRA prior to getting their device on the market. And the device manufacturer must fulfill the requirements mentioned in sections 2 to 5 of Annex III, Part IV of UK MDR 2002.

Key Takeaway:

• Joining hands with industry experts like Elexes that possess strong quality, regulatory, and project management experience, the medical device manufacturing company successfully conducted the necessary level of due diligence.
• Subsequent testing and implementation of all requirements were made possible with a clear regulatory roadmap.
• Elexes resolved all the questions from the manufacturer on placing the device in the market within the short stipulated time frame.

Performing due diligence on regulatory requirements and selecting an appropriate pathway is the most significant step in placing the device in a designated market. Irrespective of its risk classification, with the right strategy and strong interpretation of applicable requirements, attaining marketing approval is always hurdle-free and smooth for any medical device company, saving numerous man-hours, and cost.

Would you like to place your device in the UK market?

Elexes is here to help you. Our dedicated team has years of experience in supporting our clients in this process. Please contact us at jennifer@elexes.com to have us review your device as per UK regulations and guide you through the corresponding next steps.

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