- Why Us
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.
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.
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...