The withdrawal of Lloyd’s Register MDD & IVDD Notified Body Status

[JoshuaFroud]

Good Morning Cove

As some of you may be aware Lloyd's Register withdrew its notified body status for MDD and IVDD last month (see link below).

Lloyd’s Register withdraws MDD and IVDD services.

I was interested to know how many of you were impacted and how you are getting on with sourcing a new provider? Does anyone know roughly how many companies this impacted?

The MHRA in the UK has been less than clear with the guidance they have issued around the event which has not helped the situation.

 

[Sidney Vianna]

Interesting. As many people realize, after the PIP breast implant scandal, many organizations working in the Medical Notified Body space are reassessing their continual presence. Liability exposure equations have changed and some conformity assessment organizations don't have a large risk appetite.

In the case of this NB, it is also likely that Brexit might have played a part in the decision making process. Nevertheless, it is interesting to see that (much) heightened oversight of NB's, as an outcome of some highly publicized faux pas, is leading to a significant reduction of NB services providers.

I still wonder if a similar thing would happen in the management system certification sector. As it is, the trivialization and commoditization downward spiral is seriously affecting the intended outcome of providing confidence and trust in the global supply chain.