On May 26, 2017 the MDR 2017/745 and IVDR 2017/746 officially entered into force.

The new Regulations will be implemented according to the following dates.

November 26, 2017: as from this date, Notified Bodies will begin the accreditation process in order to issue CE certificates according to the new Regulation. A period of about 18 months is expected before the Notified Bodies can actually issue CE certificates in accordance with the new Regulations.

May 26, 2020: the new Medical Device Regulations implementation and the transistional period expiry official date. Until this date, Notified Bodies may still issue CE certificates in accordance with the previous Directive, but with a term of validity of up to 5 years.

May 26, 2022: the new IVD Regulations implementation and the transitional period expiry official date.

May 26, 2024: as from this date, any certificate issued under the previous Directives (MDD and AIMDD) will no longer be considered valid.

May 26, 2025: All devices with CE marking conforming to the previous Directives will no longer be marketed in Europe, but will have to adapt to the new Regulations.

For more information: http://eur-lex.europa.eu/legalcontent/IT/TXT/PDF/?uri=OJ:L:2017:117:FULL&from=EN