Member Query

Are you classifying Pregnancy Testing kits as "In Vitro Medical Devices" as these have a later implementation date within the Regs and not May 2020?

Members Responses

#1        Yes, we are classing as an in vitro MD

#2        We classify them as in vitro

#3        Yes, confirm we classify them as in vitro

#4        Yes, our pregnancy tests are classed as IVDs.

#5        Confirmed that we are treating pregnancy test kits as IVDs and are therefore aiming for a later date for MDR compliance

#6        I can confirm that we are classifying Pregnancy Testing kits as "In Vitro Medical Devices".

#7        Question: Would I consider Pregnancy kits to be in vitro medical devices?

Answer: Yes

 Current:

98/79/EC

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01998L0079-2012011179/EC 

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/377885/Guidance_for_notified_bodies_on_the_regulation_of_IVDs_for_self-testing.pdf

 New:

Regulation (EU) 2017/746  

 Rule 4 2.4 (a)