The anxiety of MDR
We’re only 8 months away from MDR’s May 26th, 2020 application date, and KPMG just shared a study stating that more than 66% of Medical Device companies have yet to develop a plan for post-MDR sustainability.
The report cites several reasons as to why companies are not ready and repeats several of the reasons I hear in conversations. The most prominent of them: guidance is not available or not clear, and there is a lack of Notified Bodies.
The EU Commission claims that guidance documents are forthcoming, and they are, but of course the window for implementation has shrunk significantly.
Lack of MDR designated Notified Bodies
As of now (Sept 28, 2019), only 5 Notified bodies have been designated under MDR: BSI UK, TÜV SÜD, IMQ, DEKRA and TÜV Rheinland.
The Commission has previously stated that we should still expect about 20 Notified Bodies by the end of this year. And I presume lots of people are working very hard to make that happen.
Nevertheless, I think the general feeling is that we will hit a wall May 2020, unless the burden can be lowered. The anxiety surrounding MDR is mounting fast and people are starting to suggest improbable scenario’s: maybe the application date for MDR will get postponed? Or the law will be reversed?
Some of these suggestions are easily rebuked. The law will not get reversed. That requires a parliamentary vote. It took years to agree on MDR and it might take years to agree on its revocation. There is no time for that. Besides, many are afraid for what might replace MDR should it be revoked. An absolute no-go.
During a recent visit to Belgium, I had the opportunity to meet people with access to the EU commission. They mentioned an upcoming 2nd corrigendum. Such corrigendum would allow for some “corrections’ to be made to the MDR. One such correction which is being discussed in particular caught my attention.
MDR requires that any manufacturer of devices classified under MDD as Class I, and up classified under MDR (for instance medical device software – embedded or not) be certified under MDR on the date of application, May 26th 2020.
The corrigendum would allow for these products to get a 4-year transitional period before having to be certified by a Notified body under MDR.
My sources tell me that such corrigendum might get published before Oct 15th 2019. At the same time, I hear that not every member state is in full support.
And maybe save MDR?
Publishing such a corrigendum will provide a lot of relief. Ironically, most of the devices that have to meet the MDR regulations on day one are the lowest risk Class I devices and the devices that have been up classified.
But Class I devices that are not up-classified are of no burden to the Notified bodies. Only those devices that have been up-classified must mandatorily have a CE certificate issued under MDR by May 26th 2020. The new corrigendum would provide significant relief.
And maybe save MDR?