Manual on Borderline and Classification in the Community Regulatory Framework for MDs (V2)

On December 15^th, 2022, a 2^nd version of the EU manual on Borderline and Classification for medical devices under the MDR and IVDR has been released which introduces (only) 2 new cases.

New manual on borderline and Classification in the Community Regulatory Framework for Medical Devices – version 2

Medical calculators:

The intended purpose of a medical calculator is to facilitate one or more (sometimes up to 400) routine medical calculations at the point of care for multiple clinical disciplines by means of an app or webpage.

Outcome: Calculation of a score according to a specific formula or an complex algorithm as mentioned in both examples is an action on data beyond the use of simple search as referenced in qualification decision step 3 of MDCG 2019-11 (“Decision steps for qualification of software as MDSW”). Also, the calculation is for the benefit of individual patients, as it does not only provide generic diagnostic or treatment pathways per decision step 4 of guidance MDCG 2019-11. The presented device meets the definition of a medical device as it is intended by the manufacturer to be used for medical purposes in accordance with Regulation (EU) 2017/745. Classification rule 11 applies, since it relates to software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes, and classifies this product as at least class IIa. A higher classification may apply depending on the significance of the information provided by the device to support the healthcare professional’s decision in the context of the patient’s condition, as per guidance MDCG 2019-11 and MDCG 2021-24.

Needle counters:

There are on the market products generally called needle counters, intended to allow the counting and to reconcile the count of suture needles and scalpels, after the procedure and before suturing the operating cavity. Some manufacturers claim that their intended use is the prevention of the severe consequences to the patient’s health if any of such items were to remain on the human body after suturing.

Outcome: Needle counters, intended to allow the counting and reconciling the count of suture needles and scalpels, as well as their elimination, after the procedure and before suturing the operating cavity, do not comply with the legal definition of a medical device, according to Article 2 (1) of the MDR, since they are not intended for any specific medical purpose, and should not be qualified as such.

Please keep in mind that this Manual only serves as one of the support tools for case-by-case application of the Union legislation by the Member States in their respective jurisdictions.