Should you Swipe Right or Left on your Notified Body?

July 7, 2019

Should you swipe right or left on your notified body_

How long have you been dating your Notified Body – “NB” for short? Is your eye beginning to wander?

It should wander if your NB won’t be able to support your business once the Medical Directive Regulation (MDR) takes hold.

If that’s the case, it may be time to ‘swipe left’ and get yourself in a new relationship.


When it’s time to move on from your current notified body

I hate to get between you and your notified body – but I’m telling you this for your own good.

Because if your NB’s not MDR-ready, your relationship – indeed, your entire European business! – is dead anyway.

Take my advice and ask your NB these questions, to see if you’re in it for the long haul.



The Acceptable Notified Body Answers

Yes, you’ll need to treat your NB like a bad date on Tinder if it fails any of these tests.
  1. Swipe left if your NB didn’t apply. You gotta be in it to win it, goes the lottery slogan. If your NB hasn’t even applied for an MDR designation, you have to say goodbye.
  2. Swipe left if the Joint Assessment looks rocky. If they haven’t scheduled their Joint Assessment Audit yet – or if they had it and they had major non-conformities, things aren’t looking good for you two.
  3. Swipe left if your NB excluded you. That’s the sign of a terrible relationship: Your NB didn’t apply for designation to support all your products. And when I say ‘all products,’ I mean future ones too!
  4. Swipe left if your NB hasn’t bulked up. The Medical Device Regulation (MDR) kicks up a ton more work versus the soon-to-be-retired Medical Device Directive (MDD). If your NB doesn’t have enough talent to service your account, you’ll want to find someone who can.
  5. Swipe left if your NB defines ‘significant’ too narrowly. There are product changes, and then there are PRODUCT CHANGES. Some PRODUCT CHANGES are ‘significant,’ no matter who you ask. Others are not so clearly in either camp. If you believe your change is ‘insignificant’ and your NB believes otherwise, your NB might be creating an unnecessary expense for you. You might want to shop around.

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A Warning

I need to emphasize the gravity of this MDR situation. If your NB can’t support you once the MDD sunsets, you will be out of business because you can’t market or sell medical devices in Europe without a current CE mark.

You may want to make that call this week.

This article was originally posted on the LeanRAQA Blog and is being republished here with permission.

Michelle Lott is the Principal and Founder of Lean RAQA, a regulatory and quality consultancy for medical device companies. Michelle currently serves a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP); reviewing feasibility and reasonableness, recommending proposed good...

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