Easy Ways To Have Better EU MDR Conversations With Your Customers

Do you see customers as just passive buyers of your devices?

Think again.

They play bigger roles in the MDR journey of a medical device manufacturer:

  • Customers can give essential user input for developing a new MDR compliant device
  • A long-time customer could sponsor a clinical study required by a Notified Body to get CE certification under the MDR
  • To meet the tighter MDR post-market surveillance requirements, manufacturers need possibly more customers to provide feedback on the use of the devices than under the MDD

Also, as the MDR changes manufacturers’ obligations, your current customers may experience the ripples of the change. Such as a device price change. They’ll want to know what’s going on and why.

Medical device manufacturers absolutely need their customers on their side to get through the MDR.

Manufacturers need customers’ trust, motivation to cooperate and shared understanding of the rules of the MDR game.

The key to achieve that?

Good old communication.

The sooner you start communicating the change, the better.

If you need to ask for favours, customers usually appreciate not being surprised by sudden requests. They value being in the loop in advance. They need time to process changes you’re laying down on them.

The more you plan and prepare for the communication, the less misunderstandings, delays and missed sales you’ll encounter.

As I’ve helped medical device manufacturers prepare for the MDR, I’ve seen customer communication that works and some that only complicates things.

Here I’m going to share with you a few tactics on how to turn MDR conversations with your customers into a success.

Get your internal ducks in an MDR row

Your employees from different departments may contact your customer for any kind of business reason.

Vice versa, more than one employee from your customer’s side may call, email or meet with someone at your company.

One topic may lead to another (enter the MDR) and a question or a concern may build up pressure on your employee to give some kind of a reply, a commitment to the customer.

If too many MDR ”i-don’t-knows” or false promises (”We’ll get the CE certificate this week and start sales next week”) get communicated to your customer and start spreading, it may not look good on you (for example if you don’t get the CE certificate and cannot legally start sales until you first run a clinical study, which can take months).

That’s why you need to make sure everyone interacting with the customer is prepared.

Create a company-level MDR communication strategy. If appropriate, divide it into communication paths per department, team or individual. Clarify roles and responsibilities. I cannot say how many times I’ve seen people worry about what they can say or when, or assume someone else is going to take care of communicating something important (and nothing gets passed on). Check that everyone understands what the message to customers should be. Focus on empowering people to do their best in their daily work.

Share MDR information with all the relevant employees early and often. Don’t keep anyone in the dark. Provide trainings. Organise all-hands meetings. Present latest news in regular team calls if working remotely. Document frequently asked questions (FAQs) and keep them easily available to all personnel.

* * * * *

Set up or refresh customer communication points

A phone call or an email with your customer is rarely enough to cement the MDR understanding.

Customers forget some details you said and want to check it later. You may see a pattern in customer questions or want customers to follow a certain process when contacting the manufacturer on the MDR issues. For these and many other scenarios, you need to provide a clear and consistent communication access to the customers.

Examples of communication points are:

  • Website
  • Social media accounts
  • Blog posts
  • Mobile apps
  • Newsletters
  • Bulletins
  • Emails
  • Presentations
  • Stakeholder magazines

Many of these communication points include an option to comment and ask questions – in other words, to keep the conversation going. It’s a good idea to have more than one communication channel. Customers have different preferences and not everyone has access to internet 24/7. Communication points provide a platform for you as a manufacturer to describe what’s changing, what solutions you’re offering and also a chance to set boundaries on how you want to work with your stakeholders and customers. Whatever route you take, emphasis should be on keeping the MDR communication clear, timely, frequent and consistent.

* * * * *

Know your customers

You may think you have your EU-based customers figured out for the MDR. The customers per EU member state, your biggest customers, and so on. Or you treat them as a group, to which you’re going to share the same MDR information and be done with it.

These approaches will not ensure your customers get your MDR point.


Because you’re not focusing on the key component of effective customer conversation: understanding your customer’s needs.

If your customer is already aware of the MDR and wants to scale it independently in their own business, you can go ahead and concentrate on talking about the benefits and advantages the MDR brings to business and cooperation between the two of you.

With a customer who has heard about the MDR but is looking for guidance on how to take it in, you need to show your MDR expertise and create value for the customer.

For a customer who has no idea what the MDR stands for and what is expected of them, you need to give a lot of attention, be prepared to walk through the basics and get their trust for cooperation under changing circumstances.

How do you get to know your customers? Use every customer contact point as an opportunity to understand their position better. Send your customers a survey to check in on their current feelings. The long-running pandemic may have created gaps you should be aware of. The worst thing you can do is to assume, overlook and do nothing. The best thing you can do is to take the first step. Get in touch.

* * * * *

Practise common questions

Despite the wide variety of medical devices, manufacturers and customers, there is common ground to be seen:

The things on customers’ minds, things that worry them, catch their attention. Things that they’re asking manufacturers.

You’d be surprised to hear how much different customers ask the same MDR questions. Here are examples of typical inquiries:

1.) What’s changing?

2.) Do we need to do something?

3.) Will incident reporting change?

4.) Which of your products will be affected by MDR?

5.) Are you going to continue supplying our favourite devices [i.e. devices under MDD] as usual? If not, why not?

6.) After MDR begins, can we keep on using the devices we bought X years ago, or are they not safe anymore?

7.) Any changes to device maintenance or service life?

8.) Will there be any effect on user training?

9.) Are you going to raise prices?

10.) I heard that a professional user could become a manufacturer in some circumstances. What does it mean?

Anticipating these common questions and rehearsing how to answer them could help you to nail for example that next sales call with your customer.

In conclusion it can be said that change is never easy. Neither is customer satisfaction. Both need a lot of work. During times of change, you need to work extra hard to maintain the trust you have with your customers, build trust with new customers, feed their motivation to work together and keep everyone on the same page.

Communication provides a powerful tool to do that.

Consistent, considerate, reliable and helpful communication goes a long way. The approach is quite simple. Equip relevant people internally, organise communication points, get to know your audience and warm up with the frequently asked questions. I’ve seen these work and I recommend you give them a try too when you’re in touch with your customers about the MDR.

How about you: Are there some other tactics that you’ve found useful? Have you come across other common MDR customer questions?

Drop a comment below. I’d be happy to read your thoughts.

If you have any MDR questions or concerns, and would like to ask an expert, please feel free to reach out to me.

Photo: Freepik (stories)

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