Do You Have a Medical Device with Batteries? Here’s The Deadline You Can’t Afford to Ignore!

The clock is ticking on removability and related requirements. Find out what you need to do. Now.

I recently met several founders who were unaware of the Battery Regulation (in force since July 2023) and the associated requirements for medical devices. For this reason, I decided to write this post to raise awareness across my network. 

Most founders assume that “medical device” means “MDR and ISO 13485”. However, there are other regulations to consider, and that includes the rules emerging from the EU's circular economy agenda. And no – medical devices are not “exempt”. They come as an additional layer on top, similar to the AI Act and you will need to consider them too.  

The 2027 deadline you cannot miss 

So, what does the regulation say? You’ve probably heard that, from 2027 onwards, mobile phones sold in the EU will need to have removable batteries. The same principle applies to your medical device.

From 18 February 2027, the regulation requires that portable batteries in any product placed on the EU market - including medical devices - must be removable and replaceable by the end user, without special tools, heat or solvents.

For founders caught up in the day-to-day challenges of running a business, 2027 may still seem a long way off. It is not. Redesigning a device to incorporate a new battery compartment is not something that can be squeezed into the final few weeks before the deadline. In addition, there are other obligations to fulfil, including supplier management requirements for battery suppliers as well as updates to your QMS and product labelling.

Few devices are exempt 

Very few devices are exempt from the regulation:  

• Safety exemption: implantable devices (pacemakers, ICDs) and devices that contact contaminated bodily fluids — where end-user removal creates a clear safety risk. 

• Pro-replacement exemption: professional imaging, radiotherapy, certain hearing aids and high-risk IVDs — batteries must still be replaceable, but by qualified independent professionals rather than end users. 

  
  

Everything else, such as wearables, point-of-care devices, home-use therapy devices, portable diagnostics, falls under the obligation. The exemption is not automatic – it needs to be justified prior to placing the product on the market.

What this means for you 

In case you are developing an electronic device with portable battery: 

• Assess if your device may be exempt and, if so, document the justification. 

• If your device is not exempt, integrate battery removability in your design now.  

• Integrate the relevant elements in your QMS and Technical documentation.  

  
  

The cost of waiting

If you know me, you’ll know that I am not one to use fear as a motivator. However, the consequences of non-compliance with the Battery Regulation can be just as significant as those of non-compliance with the MDR – and February 2027 is approaching amazingly fast.

If you need support in taking the right steps to update your QMS and technical documentation, please don’t hesitate to get in touch now.

*** Regulatory Affairs and Circular Economy - explained in plain English.

What are your burning questions right now? Let me know... they may inspire my next post!