Keeping up with the Effective Dates

Last updated 28 Feb 2024. You get up to date FDA effective dates here, and EU effective dates here. And see Notes 1 and 2 below.

FDA and EU effective dates

Note 1:  

With FDA effective dates, these apply when seeking device clearance (510(k) or approval (PMA). They don’t apply for products already cleared/approved for US market. 

As it's the US market, you need to declare to AAMI versions, as this is where any US differences are found. 

Note 2:

General:

With EU effective dates, these apply to all products placed on EU market after date.

As it's the EU market, you need to declare to the CEN/CENELEC versions, as this is where any EU differences are found. And importantly, also where coverage of the standard's requirements with the EU MDR, (EU) 2017/745, (or if in transition to MDR, with the MDD, 93/EEC/42), can be found.

MDR Transition

The new EU Medical Device Regulation (MDR), (EU) 2017/745 applies for new devices since 26 May 2021. For existing devices on the market, with valid Notified Body certs issued to older MDD, 93/EEC/42, before 26 May 2021, and still valid can be sold until 26 May 2025 (if Class I, 26 May 2024). Details are here, 2020/561. 

As an aside, in all cases, whether using MDR or MDD, the harmonized quality management system standard is EN ISO 13485:2016.

Harmonized standards for existing devices to MDD, 93/EEC/42

Here are the MDD harmonized standards, dated 24 Mar 2020. List includes older EN/ISO 14971:2012 (EN 2012 amendment has the required "as far as possible" risk acceptability criteria), and the IEC 60601 series without latest 2020 amendments. As existing devices will be transitioning at latest to MDR by 2025, it's unlikely this list will be updated. 

See also GASOTA. 

Harmonized standards for MDR for new devices to MDR, and existing devices transitioning to MDR

The MDR has only a minimum number of harmonized standards published in the OJ (EU Official Jounal). This MDR "Harmonised standards" page has links to the published harmonized standards. The OJ articles preceding the table sometimes specify "Transitional provisions" (i.e. effective dates), other times not (meaning effective when published). The latest update includes the new edition of EN ISO 14971:2019 + A11:2021 for Risk Management.

The harmonized standards page also includes a link to M/575, dated 14 Apr 2021; (and amendments dated 31 Jan 2023 and 4 July 2023,  not related to IEC 60601), which is the Commission requesting that CENELEC update their medical device standards by 27 May 2024, something that may not happen. Annex I lists the standards needing improvement. Annex III explains what improvements are needed. The Commission requests updates to Annex Z's to better outline coverage of requirements to the "general safety and performance rules", including any differences in terms and where requirements don't provide coverage. These Annex Z's exist but await improvement. For the EN standards that appear on Annex I, we can infer the Commission feels these are the standards that are nearly harmonized, which includes the EN 60601-1, its -1-xx collaterals, its -2-xx particulars, and related EN 62xxx series, and with their latest 2020/2021 amendments. 

When preparing your "technical documentation" for a device, you'll want to consider the issues raised in Annex III. For each applicable "general safety and performance rule", you'll presumably be noting the use of an applicable non-harmonized standard, and filling in any gaps in fulfilling aspects of the "rule" and any other applicable requirements from MDR related to "rule", with references to other documents such as your device's "risk management file" and "usability engineering file". 

See also GASOTA.

"Generally Acknowledged State Of The Art" (GASOTA) 

The Medical Device Coordination Group (MDCG) has published MDCG 2021-5, April 2021, to provide guidance on medical device standardization. The document outlines the importance of harmonized standards but also the importance of risk acceptability consistent with the "Generally Acknowledged State Of The Art" (GASOTA), as required by many of the "General Safety and Performance Rules" within Annex I of the MDR. it's hard to put a formal definition on GASOTA but an informal example would include a consensus standard 3 years after its publication date. if we take this view, we see that some EN standards listed in Commission doc M/575, Annex I are 3 years old in 2023 and most others are 3 years old in 2024. Perhaps their use until 2025 will be acceptable for manufacturer's of existing devices of Class IIa, IIb, and III to MDD and with valid Notified Body (NB) certificates to the MDD, after which they will have transitioned to the MDR, and presumably the newer harmonized standards. Check with your NB to be sure of their expectations. 

Note 3: GASOTA = "Generally Acknowledged State Of The Art"

Impact of these new versions

The changes to risk management and usability will probably require some update to procedures, and records, including verification documents. 

The IEC 60601 updates generally have a minor impact on equipment design, but require updates to specified safety standards, and related test reports.

Impact of IEC 60601-1-2, Ed 4.1

See here (ed 4.0) and here (ed 4.1).