5 questions with Medtech regulatory expert Anette Sjögren

MDR 2021 is getting closer and it is time to start preparing processes and creating routines for an updated standard of Post market surveillance. To understand what MDR 2021 means and how, when and why it is so important to start now, we invited Anette Sjögren, a quality and compliance expert, for a talk to straighten things out. In this blog post you can read the interview in its abstracts, you will also find a recorded version linked below.

1. What would you say would be the current status about MDR & Post Market Surveillance since it was postponed for one year, any changes?

There are no changes to Post Market Surveillance, but it gave the industry one more year to implement Post Market Surveillance. Many companies have not started yet, so I think that’s the only change I see - that people may get started to work with it in a good way. So the time was good, but the regulation is still the same.

2. What is the first thing to get started with, in the journey of reaching compliance within PMS?

Already in 2007 there was a management standard that came out with production and post production plans so it’s been there for many many years. And these are both external and internal data that needs to get into Post Market Surveillance.

3. If you have not got your arms around PMS, what to do now?

The best tip to do is of course, if they can, to start now, especially with Post market clinical follow up they would benefit the high risks classes with benefit from having more clinical data in the Post Market Surveillance when the MDR comes into force.

4. When would it be a good time to adopt a more structured process of monitoring external content?

I think they need it, definitely for the inputs. So if they want to stay on the market and develop their product and processes they need this external data to monitor what is going on in the world. What are others doing, and if they are competitors, what can the company do then do to implement those steps perhaps? So Post Market Surveillance is a proactive tool really so that the company can benefit from and improve their products.

5. What are the best tips you have to make management aware and responsive to PMS and structures needed?

Management awareness is a tricky one, but it all starts with management so it’s not a task for a QA person to run Post Market Surveillance, definitely not. It’s a teamwork that runs through the whole company. So if the quality assurance department can not implement Post Market Surveillance processes and templates, then the management will lose all the necessary information and they might not be able to have the products on the market anymore.

A big thank you to Anette for rewarding and interesting answers. MDR and Post Market Surveillance is certainly not a one-person job - planning and cooperation between the departments is required for the work to be as efficient as possible. It is also important to start now to have as much as possible in place before the regulatory change happens in May 2021. 

Do you want to learn more about how Hoodin could help you with monitoring of external digital content for Post Market Surveillance? Feel welcome to book a meeting and we will be happy to tell you more.

See the full interview here.