The European Commission’s proposal COM(2025) 1023, published in December 2025, contains a lot of sensible ideas aimed at reducing the administrative burden on medical device manufacturers.
One of the proposed changes has attracted less attention than it perhaps deserves: the removal of the pre-notification requirement and the Notified Body certificate for distributors who repackage or relabel devices under Article 16 of the EU MDR.
Parts of the Commission’s reasoning are fair. The current regime adds cost and complexity for small distributors, and Notified Body capacity is genuinely stretched. But I think this particular change deserves more scrutiny than it has received, and to explain why I need to go back a little further than the MDR.
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A Brief History of Own Brand Labelling
Before Commission Recommendation 2013/473/EU, the medical device market was full of organisations describing themselves as Own Brand Labellers. An OBL, as they were known, could take a CE marked product from an original equipment manufacturer, put it into new packaging with their own name on it, and present themselves as the manufacturer. You will have bought their products without knowing it. That adhesive wound dressing in the supermarket first aid kit was almost certainly made this way.
This was not inherently wrong. The OEM’s product was CE marked, the device was what it claimed to be, and there were some controls in place. Notified Bodies would typically ask to see an agreement between the OBL and OEM, a basic Summary Technical Documentation file, and the OEM’s CE certificate. The trouble was that none of this was specifically defined in the directive, which meant application was inconsistent across the then roughly 80 Notified Bodies operating across Europe. Some were thorough. Others were less so. The same OBL could be treated very differently depending on which body they ended up with.
The 2013 recommendation changed that. OBLs were now required to consider themselves as manufacturers, which meant full technical documentation, their own QMS, and formal conformity assessment. The term ‘virtual manufacturer’ emerged from this period to describe these organisations, with the MHRA widely understood to have been a driving force behind the scenes in pushing for the change. They had never been comfortable with the OBL arrangement, and the new framework gave that discomfort formal teeth. But the transition, as transitions often are, was rather illuminating about the state of the market. To explain why, I need to take you back to a bedroom not so Far Far Away…..
A Story From the Auditing Coalface
I was working as an auditor when the new requirements came into force, and the audits that followed were, to put it diplomatically, varied in their findings. One in particular has never quite left me. The account that follows draws on real experience. Identifying details have been changed to protect confidentiality.
I arrived at the registered address for what should have been a routine virtual manufacturer audit. The address was residential, which was not unusual for very small operations. I was shown upstairs, which was slightly more unusual, and led into the owner’s daughter’s bedroom. Getting a bit odd, I thought. Then the client opened two wardrobes. One was full of ring binders. The other was full of small pouches of labelled stock, apparently ready for sale. He told me to look at whatever I needed, and if I had any questions I should call him. Then he mentioned he was going to visit a relative in hospital and before I had even unpacked my laptop, he left.
I sat in that bedroom for a moment, genuinely weighing up whether to call the whole thing off. I decided to crack on and see what I was dealing with. The ring binders contained phone records, bank statements, tax documents, and various other personal business paperwork. There was no quality manual. No internal audit records. No procedures of any description. The OEM contract was there, and the CE certificate, as expected, but that was essentially it in terms of anything resembling a quality system.
Then I looked at the product. It was a Class IIa device. The address on the label was different to the address I was sitting at, which was itself different to the address on some of the business documentation in the ring binders.
I called the client back. When he returned, it emerged that the business had been handed to him by a family member and that he had since moved house. He had no meaningful understanding of the Medical Devices Directive, post-market surveillance, or quality management of any kind. He was not a fraudster. He was simply a person who had found himself running a regulated medical device business without anyone having explained what that actually meant.
As an auditor, my job was to document the nonconformances, hand them back, and leave. I could not tell him what to fix or how to build what he needed. I wrote it all up, gave him his findings, and drove home. It was not the last time I sat with that particular feeling.
Why This Matters Now
That bedroom was extreme, yes. But the underlying pattern was not unusual. Not by a long stretch. The pre-2013 OBL landscape was genuinely poorly controlled, and the introduction of formal requirements, including NB oversight, was a direct response to exactly that reality. The current Article 16 framework under the EU MDR builds on that foundation. Distributors who repackage or relabel must notify the original manufacturer at least 28 days before making the device available, give the manufacturer the right to object, and submit a Notified Body certificate confirming their QMS meets the requirements of Article 16(3).
The Commission’s proposal would remove the pre-market notification requirement and the NB certificate. There might still be a general obligation to inform, but the gate itself, the bit that actually stops anything, would be gone
On paper, the administrative argument makes sense. For a small distributor making modest label changes to sell a well-established device in a new market, the current process can feel disproportionate. Pointing stretched Notified Body capacity towards lower-risk repackaging activity is hard to defend as the best use of a limited resource.
But there are real risks on the other side of that calculation. Repackaging, even when done carefully, is not trivial. Sterile barrier integrity, labelling accuracy, storage conditions during the process: these are genuine patient safety considerations. The current regime forces a degree of rigour by requiring independent verification. Without it, the burden shifts entirely to the distributor’s own QMS, the robustness of which will vary considerably across the market.
The original manufacturer currently has a formal right to object if they believe a repackaging or relabelling activity could compromise their device or their reputation. Removing pre-notification weakens that protection in a meaningful way, even if a general right to be informed is preserved. National competent authorities, already stretched in terms of market surveillance resource, will lose the NB certificate as a proactive marker of reviewed relabelling activity, shifting their oversight from preventive to reactive.
There’s another risk that those closest to market surveillance know all too well, though it’s rarely discussed openly for obvious reasons. Those who know me will not be surprised that I’m going to say it anyway! Remove that formal gate and it becomes considerably easier for someone to muddy the trail of where a device really came from, or to make modifications that go beyond legitimate repackaging without anyone looking too closely. Particularly in lower-risk device categories where scrutiny is already lighter.
The legislative process is still running, and the final text may look quite different from what is currently proposed. That is not reassuring in itself, given how much disruption has already taken place. Right now, businesses are trying to plan in a fog, and no one can say with confidence what the final obligations will look like.
Are we genuinely learning from the pre-2013 landscape, or just drifting back towards it because the paperwork is inconvenient? The Wild West was not a safe place for patients or for legitimate manufacturers. The sheriff’s office was hard won. Anyone who lived through the OBL era remembers exactly why it was needed. It would be a shame to dismantle it for a cosmetic efficiency.
If you are a distributor or manufacturer trying to understand how the proposed changes to Article 16 might affect your operations, or how to ensure your current arrangements are robust regardless of how the legislation develops, I am happy to talk it through.