Now is an excellent time to examine MDR learnings. The MDR Date of Application (DoA) turned one year last week on May 26th.
Every economic operator selling, importing to or distributing medical devices in the EU, EEA and Turkish medtech market is now signed up for the MDR class. Some are learning the MDR ropes as they go through the MDR transition. Others have already passed the first MDR conformity test and are learning to live in full MDR compliance.
It’s not easy for anyone. I’ve seen it firsthand when helping manufacturer, distributor and importer clients get through the MDR. There have been both headaches and achievements, complications and results. I’ve developed quite a good eye at seeing what methods typically work well and which don’t.
I want to help any manufacturer, distributor and importer out there to avoid learning the MDR the hard way like some have done before them. Next I’m going to share 5 MDR lessons learned so that companies could go from bottleneck to progress easier.
1. Treat the DoA as an intermission or a start
Don’t let the DoA fool you, you class I device manufacturers. Sure, it was the deadline when you needed to self-declare conformity to MDR if you wanted to keep your still-class-I-devices-under-the-MDR in the EU, EEA and Turkish market. After putting a lot of effort into your QMS, technical files, UDI, PMS and whatnot systems, the DoA must have felt like the finish line. But the work continues.
From the DoA on, the QMS, technical files, UDI, PMS, etc. must be kept up-to-date for the lifecycle of the devices. If you let the ball drop, have you considered how to present conformity evidence to a competent authority? They can request it anytime.
As for manufacturers applying Article 120(3) to their legacy devices, the DoA marked a beginning. Those manufacturers needed to start complying with the requirements of the MDR on the DoA as far as post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices go.
So manufacturers applying Article 120(3) have had to incorporate parts of the MDR into their systems while being MDD certified. The Notified Bodies are checking up on this during the surveillance audits. As a manufacturer, do your operations show you have taken the required MDR parts in?
2. Invest in enough resources
MDR is a huge undertaking for any company. Both to achieve the MDR conformity and to maintain it. For one or two people to do it all…it will take a lot of burning the midnight oil.
It’s perfectly OK to ask for help. Many companies have hired or are hiring new staff. Or they are using subcontractors. If you are for example unsure of how to interpret the MDR or don’t have time to update all the technical files, doesn’t it make sense to get more helping hands?
3. Keep your ear to the MDR ground
If an economic operator has listened to MDR presentations a long time ago, or time has passed when they last consulted an MDR expert, chances are they are not aware of the latest developments.
For instance, the MDR was amended in 2020, new MDCG guidances are published even as we speak and workarounds have been established to accommodate the lack of a fully functional MDR infrastructure. All these can impact the route the economic operator is taking with the MDR.
Instead of locking their MDR knowledge for good, companies should find ways to keep continuously abreast of MDR news and developments. You do want to avoid costly surprises, right?
4. Prioritise creating an MDR strategy
A change as intensive and many-sided as the MDR can make any economic operator’s head spin. Some react by focusing on details, which can be easy, fast and affordable to manage. As they learn more, they change their approach. And when they finally talk to someone with a good MDR head on their shoulders, they realise they have to return quite near square one.
Sure it’s not easy to set all the right steps at once. However, going back and forth is not sensible either. All the changes in direction cost time and money. By focusing first on the big picture, an MDR strategy, you can save time and money. It’s easier and less expensive to tweak tactics after that.
5. Understand your role and the new rules
In the past a company may have manufactured some medical devices, outsourced the manufacturing of certain devices, and imported or distributed others. With the MDR the game changes. The definitions of the economic operator roles have been updated and fixed obligations are assigned to each defined role.
A company does itself a favour if it takes time to first understand what roles the MDR recognises, which of those roles the company fits into, and what responsibilities come with the roles. With these discoveries, many hold-ups and confusions can be prevented. And needless to say, time and money can be saved.
Achieving and maintaining MDR compliance may involve trial and error. The MDR is still a relatively new regulation that manufacturers, importers, distributors and others are gradually adjusting to. By taking into account these 5 MDR lessons learned, your company could avoid making some of the mistakes that others have made.
Have you encountered other lessons learned that you’d like to share? I’d look forward to reading your comments.
Are you struggling to get your devices MDR ready? Or do you need help maintaining the MDR compliance? Please get in touch and we can talk more.