European Commission Updates Borderline Device Classification Manual
Posted 08 January 2018 | By
The European Commission (EC) last week released an update to its manual on classifying "borderline" medical devices featuring clarifications as to the medical device status and classification of on twelve additional types of products.
The manual, which is now in its eighteenth version, is meant to serve as a tool or reference for case-by-case device determinations, though the recommendations in the manual are not legally binding and such decisions are ultimately up to national competent authorities to decide.
The manual also serves as a complement to MEDDEV 2.1/3 Rev. 3, which provides guidance on borderline products and other medical devices that incorporate pharmacological or biological substances.
|New Additions to the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices|
|Product(s)|| Considered to be a device?|
|Products intended to reduce the effect of alcohol||No, "Reduction of the absorption of ethylic alcohol, without any medical purpose, in order to reduce the blood content in alcohol cannot be considered a medical purpose."|
|Radiation shields||No, "The purpose of these shields is similar to that of filters used for general protection of the persons in the building."|
|D-mannose for the prevention of urinary tract infections||No, acts "by a pharmacological mode of action."|
|Solution of 8-MOP in extracorporeal photochemotherapy||No, acts "by pharmacological, immunological and metabolic action."|
|Alum styptic pencils||Yes, Class IIa|
|Microplate washers||No, "should be regarded as a general laboratory product."|
|Tissue expanders used in the breast||Yes, Class III|
|Dura guard for use with a craniotome||Yes, Class III|
|Heart bypass machine||Yes, Class III|
|Liquid nitrogen for cryopreservation of cells and tissues of human origin for medical purpose||Yes, Class IIa|
|Mobile application for managing pictures of moles||No, "This app … does not perform an action on data other than just storage."|
|Mobile application for the assessment of moles||Yes, Class I|
However, despite the updated recommendations made in the manual, some medical devices' classification could potentially change under the EU's new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), which come into effect in 2020 and 2022, respectively.
Under both the MDR and IVDR borderline device decisions are still left up to the individual member states, though for consistency, the European Commission will have the authority to, on its own initiative or at the request of a member state, make decisions on specific borderline products in consultation with the Medical Device Coordination Group (MDCG) and with any other relevant EU regulatory authority, such as the European Medicines Agency (EMA), European Chemicals Agency (ECA) or the European Food Safety Authority (EFSA).