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Why The Humble Swab Could Be A Seriously Disruptive Element In The MDR And IVDR

 
• By Amanda Maxwell

Health care is about to suffer a major setback and some devices and IVDs are going to have to be held back from the market if the regulatory status of the humble swab is not sufficiently recognized and urgently addressed.

Medical healthcare technologist holding COVID-19 swab collection kit, wearing white PPE protective suit mask gloves, test tube for taking OP NP patient specimen sample,PCR DNA testing protocol process

The insufficiently addressed regulatory position of swabs is threatening to cause major interruption to IVDs being certified against the IVD Regulation. Many may be surprised by this since swabs are medical devices.

No Time To Lose

A significant proportion of IVD manufacturers seem unaware of the need to regulate their IVD kits containing swabs and the closer they leave it to the 26 May 2022 deadline for the full application of the IVDR, the more challenging they are going to find compliance.

This is particularly the case because some 85%-90% of IVD products are going to need to be certified under the IVDR by a much smaller number of notified bodies than the 18 existing now under the IVD Directive when only some 10-15% of IVD products need notified body involvement.

Indeed, at present, only four notified bodies have been designated under the IVDR – three of which are in Germany and one in the Netherlands. While there is pressure on the European Commission to have more designated, it seems that only 14 notified bodies have applied for designation under the IVDR. (Also see "EU MDR Notified Body Designations Could Soar By A Third By End Of 2021" - Medtech Insight, 9 March, 2021.)

Given considerable variation in the performance characteristic of swabs, some IVD manufacturers choose to include them in their kits to...

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