Hi Maggie. Unfortunately this is not an easy answer. I was at training on MDR conducted by a large Notified Body and even they could not answer the question directly.

There were a LOT of “I don’t know” and “we don’t know because the competent authority doesn’t knows.”

I know some companies are planning to do some level of small clinical trial to augment their post market surveillance data. I would encourage you to renew your MDD certificate before the May 2020 deadline so you can maximize the transition timeline for conversion to MDR.

This will give you runway as industry, Notified Bodies, and Competent Authorities figure out together.

Thanks Michelle.
I am simply looking for answers how to do not over do it.
If an organization has the Intended Use, has addressed PMCF, has a PMS plan and no changes to the device, should they be OK?

What additionally would be required for an existing Class IIa/b or even a Class III device under the MDD transitioning to the MDR that has ben on the market for years?

Hi Maggie,
Most companies have used justifications for why PMCF studies are not required. Instead of clinical studies, they have conducted literature searches and written CERs using clinical publications for equivalent products. Many companies have received major NC in the past two years indicating that the equivalence justification was not sufficient. For compliance with the MDR, you will have three (3) choices: 1) conduct a clinical study, 2) conduct PMCF in the EU, and 3) conduct PMCF in the USA. Since PMCF studies are generally less costly than clinical studies, and you can even use retrospective data, I expect most companies to launch new products in the USA for the purpose of gathering PMCF data.

Thanks for the comment Rob.

Rob, when saying "Many companies have received major NC in the past two years indicating that the equivalence justification was not sufficient", I assume that you are referring to their CERs being oriented to the MEDDEV 2.7.1 Rev 3 rather than the Rev 4?

Yes Christine. That is what I was referring to.