DATELINE 27 MAY 2021 (I will be adding some links below as I go as well): Wow! Some companies made it just across the line in time and I’m sure some didn’t. Did you? Not everyone agress with my perspective. Let’s get on with the story.

What does that all mean?

The MDD and AIMDD are dead (Dead on Arrival) and the MDR Date of Application (DoA) has just flown by us, yesterday. So, we are past the transition period, per say, for the MDR and now we’re into a grace (grey zone) for the legacy MDD/AIMDD products that can’t have any significant changes under their existing MDD/AIMDD certificates otherwise they need to go “full up” into MDR-land.

But wait there is more. All medical devices that are still certified by a Notified Body to the MDD & AIMDD with a valid CE certificate that can expire as late as May 26, 2024 have to comply with certain MDR requirements now which are based on Article 120(3) of the MDR. These requirements include: post-market surveillance, market surveillance, vigilance, and registration of economic operators or operators & of devices. Expect your Notified Body will be auditing you for these items.

On 26 May 2021 there were a lot of blog posts on the subject of MDR DoA, Article 120(3), Swexit, Turkxit, and so much more around this so rich subject so as a present to you I’m going to point you to some of my favorite resources and authors and some additional resources of interest that you may want to review:

Happy MDR DoA and Swixit / no Turkxit day! medicaldeviceslegal – Thx Erik Vollebregt for always explaining the nitty gritty of the MDR / MDD / AIMDD/ IVDD / IVDR to us. As a bonus I am adding LinkedIn post from Erik as well. You never know where the conversations may end up but they are always interesting.

D-0 MDR Day Monir El AAzzouzi of Easy Medical Device LinkedIn Post. Monir provide some great resources on MDR in the form of pdocasts and other training tools including blog posts. He recruits some of the best minds for his podcasts/webinars LinkedIn Posts, etc. He is quite the social media mogul.

And we are live! The MDR Hurdle race is on! Qserve Group – This podcast series is an excellent resource – I have known Gert for many years now. He is one of the heads of Qserve and has many years of Notified Body & Team NB expertise prior to joining Qserve. We have cooperated on some standards development work.

MDR’s Day One: Experts weigh in RAPS – RF News in FOCUS Series. Society for Regulatory Professionals. Has many good resources and growing. RAPS Regulatory Exchange is a great resource to exchange ideas and gain new information (you have to be a member to use this resource).

Important LinkedIn Posts from Mario Gabrielli Cossellu (Policy and Legal Officer at European Commission):

EU MDR Date of Application roundup: EMDN, eIFUs, UDI helpdesk, clinical investigation EMERGO by UL – This article is a summary of various items they are rounding up information on for the MDR but not specific to DoA issues.

Questions & Answers: Application of Regulation on Medical Devices – EU rules to ensure safety of medical devices Direct from the European Commission as of 26 May 2021.

NOTICE TO STAKEHOLDERS: STATUS OF THE EU-SWITZERLAND MUTUAL
RECOGNITION AGREEMENT (MRA) FOR MEDICAL DEVICES Notice from the European Commission on the Status of the EU – Switzerland MRA for Medical Devices.

Join the conversation on LinkedIn and add comments to the conversation there.

Confused by the MDR? 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. Feel free to schedule a call with Leo www.EisnerSafety.com/Schedule-Call/ or contact Leo at  or through our contact form at https://eisnersafety.com/contact_eisner_safety/.

Happy MDR + Day 1 Past DoA