Feb 2022 – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Wed, 22 Nov 2023 08:08:13 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png Feb 2022 – Eisner Safety Consultants https://eisnersafety.com 32 32 FDA EMC IVD Standards Analysis https://eisnersafety.com/2022/02/20/fda-emc-ivd-standards-analysis/?utm_source=rss&utm_medium=rss&utm_campaign=fda-emc-ivd-standards-analysis Sun, 20 Feb 2022 18:38:18 +0000 https://eisnersafety.com/?p=7163

On December 20, 2021 the FDA Released their Recognition List Number 057 through their online db. With that publication of list 057 two, EMC IVD standards were added to the list.
But the FDA only Partially Recognized IEC 61326-1:2020 and IEC 61326-2-6:2020.
What does that mean to IVD EMC tests?
We have done a detailed analysis that has been confirmed by FDA’s EMC experts to let you know what EMC tests you need to conduct in order to meet both FDA and EU requirements for IVD equipment.

If you have IVD devices that you are submitting to the FDA you will need to be aware of these requirements. Rely on our experts for this analysis. We have had discussions with the FDA to understand the issues so we can explain this information.

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]]> UK Northern Ireland Marking Guidance Updated https://eisnersafety.com/2022/02/02/uk-northern-ireland-marking-guidance-updated/?utm_source=rss&utm_medium=rss&utm_campaign=uk-northern-ireland-marking-guidance-updated Wed, 02 Feb 2022 17:50:16 +0000 https://eisnersafety.com/?p=7096

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 applies for Northern Ireland specifically.

Contents of the current UKNI Guidance is

  1. Overview
  2. Check whether you need to use the UKNI marking
  3. When to use the UKNI marking
  4. How to use the UKNI marking
  5. Technical documentation
  6. Webinars
  7. More information

The Guidance document also points users of the Guidance to the other Marking of concern. It states “For similar obligations that apply when using other conformity markings, see how to use the UKCA marking.” This is for placing goods on the British (UK) market.

Another link in the Guidance that is critical if you need to place a medical product on the UK market is looking at the UK Market Conformity Assessment Bodies (UKMCAB) database. This db you want to make sure you find a Medical Device Assessment Body that covers your device. At first glance there now are a lot of bodies (157 currently) in the db but not all of them fall under medical devices. There are still only 3 of them and they are the usual suspects being BSI, UL and SGS. Best way to search is under the “Medical Device” under the Legislative Search details option.

Need Help?

Need help with the UK, EU MDR requirements, IEC 60601 (Medical Electrical Equipment), work thru strategic planning for your medical electrical product lines, need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

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