The EU's MDR Fix Won't Undo What Your Supplier Already Discontinued

Why this matters now

On 16 December 2025 the European Commission proposed a targeted simplification of the Medical Device Regulation and the In Vitro Diagnostic Regulation, aimed partly at the cost burden that has been pushing small manufacturers out of the market. That is genuinely good news for the companies that make a lot of what a dental practice buys: drapes, envelopes, small instruments, barrier products. It is not, however, a fix for what has already happened. Several of those manufacturers have already trimmed their ranges under the current rules, and the proposal does not bring any of those products back.

What actually changed

The Commission's proposal has not become law. It has gone to the European Parliament and the Council for the ordinary legislative procedure, and the Commission's own account of it says changes are still possible before it is adopted. What it currently contains, for small manufacturers:

• A notified-body fee reduction of at least 50% for micro enterprises and at least 25% for small enterprises.
• The option for small and micro enterprises to defer paying conformity-assessment fees until the assessment is actually finished.
• Removal of the requirement that an externally contracted Person Responsible for Regulatory Compliance be "permanently and continuously" available, which had forced some small firms to carry regulatory staff they otherwise did not need.

MedTech Europe's own report on the administrative burden of the MDR and IVDR, covering clinical evaluation, notified-body assessment, post-market surveillance, EUDAMED and economic-operator obligations, argues that several of these requirements add cost without adding much safety value — which is the case the Commission's proposal is responding to.

The scale of what it is responding to is visible in Germany. Dental Tribune reports that the country has lost more than 10,000 micro and small medical device manufacturers since 2014, and that the surviving small companies' combined share of industry turnover has fallen from roughly 75% to a little over 36%. Dentaurum, a German dental manufacturer founded in 1886, has already withdrawn around 1,000 products because of MDR compliance costs, with further discontinuations expected as transition periods for older certificates run out by the end of 2028.

What this means in the operatory

None of this is retroactive. If a product you have reordered for years quietly disappears from your supplier's list this year, this proposal is not why, and it will not bring it back even if it passes exactly as written. The withdrawal already happened, under the current rules, for cost reasons that have nothing to do with whether the item was safe or effective.

That matters for how you react when it happens. A genuine safety recall comes with a field safety notice and instructions for returning or disposing of stock. A discontinuation for compliance cost usually looks much quieter: the line is gone from the order form, or a rep mentions it is "no longer available," with no notice and no explanation required. Treat the two differently — one needs a report, the other just needs a replacement.

If you rely on a product made specifically for one piece of equipment, that single-purpose fit is also a single point of failure. A barrier or accessory built to work across several sensor, scaler or imaging brands is less exposed if one manufacturer trims its own line, because switching equipment brands does not force you to switch your consumables as well.

What to check

• When something disappears from an order form, ask the supplier directly whether it is a recall or a business discontinuation — the answer changes what you need to do.
• Before reordering, confirm a direct substitute exists, or whether a multi-brand-compatible product covers the gap instead.
• Check the CE mark and notified-body number on any replacement's packaging; the proposal does not change what should already be printed there.
• If your supplier still sells items under a legacy MDD certificate, ask when that certificate's transition period ends — many run out by 2028, independent of this proposal.
• Do not assume December's proposal has already taken effect. It has not, and the Commission itself says it can still change before it does.