Investigation, replacement or modification of the anatomy or of a physiological process

Investigation, replacement or modification

Investigation, replacement or modification of the anatomy or of a physiological process

includes devices that claim to be able to investigate, replace or modify the anatomy or a physiological process.

Examples that are unlikely to be devices include: • Educational anatomy and physiology apps and software.

Indicative words and phrases:

Control of conception

Control of conception - includes devices that claim to be directly able to make pregnancies more likely or to be able to prevent pregnancy.

Examples that may be devices include: • Apps intended to facilitate conception and enable contraception based on basal body temperature • Stand-alone software application for conception and contraception purposes using data entered by the patient

Examples that are unlikely to be devices include: • Apps and software that just track or display data related to a woman’s menstrual cycle to aid in ovulation prediction. • Apps and software that just provide tips or advice.

IVF use

Software intended to analyse blastocysts for reintroduction into the body are not considered to be IVDs:

According to Part A of MEDDEV 2.14/1 rev 2 Jan 2012 “Borderline and classification issues.” (https:// ec.europa.eu/docsroom/documents/10322/attachments/1/translations) an IVD is used in vitro for the examination of a specimen derived from the human body and where such specimen is never reintroduced into the body. Without a containable specimen derived from the human body, the product will be a medical device and not an IVD. The blastocyst is intended to be reintroduced into the body and is therefore not a specimen for examination. Software for the examination of a blastocyst is therefore a medical device and not an IVD.

See Borderline manual 9.9-9.11

Indicative words and phrases:

Fertility Ovulation Menstruation Contraception IVF