Class IIb implants: what changes in the EU 2026 exemptions list

Key data

Manufacturers of class IIb medical implants operate in a regulatory environment where each update to the exemptions list can represent a substantial change in their compliance costs. The Delegated Regulation (EU) 2026/1359, published on 29 June 2026, amends the Regulation (EU) 2017/745 on medical devices (MDR) on a specific and high-impact point: which class IIb implantable products are exempt from individual evaluation of their technical documentation by a notified body.

The decision of whether an implant is or is not on that list is not a technicality: it directly determines the applicable conformity procedure, the certification cost and the speed of access to the European market.

What does this regulation establish?

The MDR (Regulation 2017/745) establishes that class IIb implants —medium-high risk— must go through a notified body to obtain CE certification. Within that process, there is a specific obligation: the notified body must evaluate the technical documentation of each product individually.

However, the MDR itself contemplates a list of exceptions: products for which that unit-by-unit evaluation is not mandatory and can be replaced by an evaluation by product type. This is the list that is now being updated.

Important: the exemption does not eliminate safety controls. It simply allows the review to be done at the product category level, not unit by unit. Manufacturers remain obliged to maintain all technical documentation in order.

Class IIb implants include, among others, joint prostheses and vascular implants, as expressly recorded in the regulation as representative examples of this medium-high risk category.

Economic and operational impact

The economic effect of this update depends directly on whether each manufacturer's product has entered or left the exemptions list:

• Product that becomes exempt: the manufacturer can replace individual evaluation with product type evaluation, reducing the time and cost of the certification process with the notified body.
• Product that ceases to be exempt: the manufacturer now requires mandatory individual evaluation of the technical documentation of each product, increasing certification costs and potentially extending market access timelines.
• Product with no changes on the list: no immediate impact, but it is advisable to verify it formally.

For notified bodies, the update requires them to review and adapt their audit procedures to align with the new list. Those with active contracts with manufacturers whose products have changed status will need to renegotiate the scope of their services.

The most serious risk is that of commercialisation without updated compliance: if a manufacturer fails to detect that its product has left the exemptions list and continues to operate under the previous regime, it may face blocking of commercialisation in the European single market.

Who does it affect?

• Manufacturers of class IIb medical implants with products commercialised or in the certification process in the EU: must verify whether their products remain included or have been excluded from the updated list.
• Notified bodies that certify implantable medical devices: must adapt their audit procedures to the new list.
• Medical device distributors in the EU that commercialise class IIb implants: must ensure that the products they distribute have the correct certification under the new regime.
• Regulatory and quality managers in companies in the sector: are the first to have to review the position of each product on the updated list.
• Advisors and consultants on regulatory affairs in the medical devices sector: must update their knowledge of the list to correctly advise their clients.

Practical example

Imagine a European manufacturer of hip joint prostheses —a typical class IIb product— that until now had its model included on the MDR exemptions list. Under that regime, its notified body evaluated the technical documentation by product type, not unit by unit, which allowed it a more agile and economical certification process.

Following the publication of Regulation 2026/1359, the manufacturer must check whether that prosthesis model remains on the updated list. If it has been excluded, it must immediately initiate the individual evaluation process with its notified body, review its technical documentation and assume the additional certification costs. If it does not do so and continues to commercialise the product under the previous regime, it risks blocking its access to the European single market.

The first step —consulting the updated list— is mandatory for any manufacturer in this situation, regardless of whether they expect changes or not.

What should companies do now?

1. Consult the updated list of Regulation 2026/1359 and verify the exact position of each class IIb implantable product in your portfolio: whether it remains exempt, whether it has ceased to be so, or whether it has entered the exemption for the first time.
2. Communicate the changes to the notified body you work with. If any product has changed status, it is necessary to review the scope of the certification contract and the applicable audit procedures.
3. Update the technical documentation of the affected products to reflect the new applicable conformity regime, whether individual or type evaluation.
4. Review internal quality control processes to ensure that the compliance management system is aligned with the new list.
5. Inform distributors of the affected products about any change in certification status, to prevent them from commercialising products under a compliance regime that is no longer valid.
6. Document the analysis performed and the conclusion reached for each product, as evidence of regulatory diligence in the event of an inspection.

Official source

Consult full regulation at official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=CELEX:32026R1359