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Wrong priorities all over

Regulatory Rabbit

I have been wanting to write here for weeks, but have seriously and simply been so bombarded with work that it just wasn’t possible. So much is going on that I wouldn’t even know where to start.

MDR craziness has fully arrived, other craziness as well. Work-Life has become a whirlwind of new MDR activities, documents and discussions. At the same time, we also try to keep up with everything to be done for the MDD (before and after the May 2020 deadline). I’m sure I’m sharing this with most of the industry right now.

Regulatory Rabbit

I’m living in two worlds already, and in addition, because my company is what it is, we, of course, have significant changes in the pipeline to be implemented within the year and the associated MDD certificate was not renewed, so will expire next year.

Because… you know, when it comes to MDR, we wouldn’t want to miss any of it! lol. And don’t bug me about the expiring MDD certificates, it wasn’t my decision.

I’m back to my “Well, I told you so” role when it comes to that topic. No time for futile discussions right now. We have what we have and we don’t have what we don’t have. More of the latter, in any case.

And regarding SARS-Cov-2… well, it’s not helping. So far, we don’t have a significant number of sick leaves, but as my company is very remote-work-averse, I fear that we are risking the sparse resources we have. I know of at least one colleague who is “young” (under 30), but with an underlying respiratory disease and the fact that he has been blocked from working remotely has me fuming at management. It’s ethically unacceptable to the utmost!!… and, I nearly don’t dare to mention that we also need him and the documents he will write for our submission timeline. We need each and every person we can get at the moment! So what’s worse than having someone being approachable only via email and phone? Right – someone not approachable by any means because of being ill, plus the unnecessary, potentially preventable suffering. I always thought that was one of the basics of risk management, to not take preventable risks. But guess what, it looks as if I’m wrong.

Management acts as if a drain of knowledge would not matter. So when will it start to matter, how many people will it need?

They may have forgotten that we have current vacancies already and the workforce is already now strained with all that there is to do. Every further person missing will tear more holes. And my colleague is even someone who spoke out about his condition. What about others who do not feel like sharing their personal health record with the company? After all, it’s a private thing, or isn’t it anymore?

Regulatory Rabbit

Apart from all the overdue guidance for the MDR, I’m now also missing sensible guidance from within the company. As with the rumours whether SARS-Cov-2 and its COVID-19 will finally make for a delay of the MDR deadline… I’m not so sure. IMHO, the EU regulators have always accepted and expected the manufacturers to take complete responsibility for their products, whatever.

Regulatory rabbit

Why should they change the system to accommodate industry this time? When have they ever done so? Audits can still be postponed or some replaced by remote audits. Maybe, the EU regulators will be moved to reconsider if the member states throw in a word because they don’t manage with their implementation in time… But otherwise, I’m not sure. The regulation is in place since 2017, the EC has done its job. The others, including MDCG are left to grapple with it. And so we will (see).

PS: new MDCG guidance! Finally.. (not to say too little, too late)

Say goodbye to wasting time and money on digitising your regulatory activities.


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