Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.
Draft EUDAMED Roadmap of Modules
FDA’s ASCA Program Becomes Permanent
Great News!!!! Effective 19 September 2023 FDA’s Accreditation Scheme for Conformity Assessment (ASCA) Program converted from a pilot program after 3 years to a permanent program, the agency announced. The transition is authorized under the Medical Device User Fee Amendments
FDA Recognizes IEC 60601-1 Edition 3.2
On April 3, 2023 FDA added IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment – Part 1: General requirements for basic safety and essential performance to their list of Recognized Consensus Standards as Recognition # 19-49 in Recognition List
FDA Swiftly Recognizes AAMI 60601 Amended Standards 30 May 2022
The FDA in a little over a month on 30 May 2022 (that is swift) has updated the Recognized Consensus database for the AAMI 60601 Amendmended Standards that are referenced in my previous post of May 13, 2022. The AAMI
UK Northern Ireland Marking Guidance Updated
2 February 2022 On 1 February 2022 the Gov.UK website updated their Guidance on Using the UKNI Marking. It was originally published on 31 December 2020. This is guidance for placing goods on the Northern Ireland market. The UKNI mark