EU 2026 Medical Device Certification: What Changes for Manufacturers

Key data

Medical device and in vitro diagnostic manufacturers operating in the European Union must pay immediate attention to the Commission Implementing Regulation (EU) 2026/977, published on 5 May 2026 and in force since 4 May. This regulation harmonizes quality management and procedural requirements applicable to notified bodies conducting conformity assessments under the MDR Regulation (2017/745) and the IVDR Regulation (2017/746).

The impact is not limited to notified bodies: any manufacturer that relies on one of these bodies to certify their products may see their audit timelines, certificate renewal schedules or contractual conditions altered. Acting now is cheaper than managing a certification suspension later.

What does this regulation establish?

Regulation 2026/977 establishes uniform standards to ensure consistency and rigor in medical device certification processes across the EU. In practice, this translates into three blocks of requirements for notified bodies:

• Internal quality management systems: Bodies must adapt and update their quality management systems to the new uniform requirements established by the European Commission.
• Documentation: A review and adaptation of internal documentation supporting conformity assessment processes is required.
• Operational procedures: The procedures governing how audits, reviews and certificate issuance are conducted must be adjusted to the new standards.

This regulation acts as a harmonization layer on top of the MDR and IVDR Regulations, which already established the general framework for medical device and in vitro diagnostic product certification in the EU. The objective is to eliminate differences in criteria between notified bodies in different Member States, something that has generated friction in the single market in recent years.

Economic and operational impact

The economic impact of this regulation is not measured in direct fees, but in indirect operating costs and the risk of business interruption. The main impact vectors are:

• Certification timelines: Notified bodies will need time to adapt their internal systems. During this transition process, audit and certificate issuance timelines may be extended, delaying product commercialization.
• Certificate renewal: The conditions under which existing certificates are renewed may change, requiring manufacturers to undergo more demanding processes or document additional information.
• Risk of designation suspension: If a notified body fails to comply with the new requirements, its designation may be suspended. This would directly affect the validity of all certifications issued by that body, forcing manufacturers to seek an alternative body and repeat conformity assessment processes.
• Contract review: Existing contracts with notified bodies may not contemplate the new standards, creating legal uncertainty and possible renegotiations.

Who does it affect?

• Notified bodies designated under MDR and IVDR: They are directly obligated to adapt their quality management systems, documentation and operational procedures.
• Medical device manufacturers (MDR 2017/745): Any company that manufactures medical products and requires certification from a notified body to market them in the EU.
• In vitro diagnostic manufacturers (IVDR 2017/746): Companies that produce tests, reagents and other in vitro diagnostic products intended for the European market.
• Regulatory and quality departments: Internal teams responsible for managing relationships with notified bodies and keeping certifications up to date.
• CFOs and operations directors: Those who must anticipate possible delays in product launches or additional costs from recertification processes.

Practical example

A Spanish manufacturer of Class III medical devices—the highest risk category, such as implants—has its current MDR certification issued by a German notified body. That body must now adapt its internal procedures to Regulation 2026/977.

If the notified body does not complete the adaptation on time and its designation is suspended, the Spanish manufacturer would find itself with a certification whose validity could be compromised. It would have to identify another available notified body—given the capacity shortage already existing in the market—initiate a new evaluation process and assume the associated costs and delays.

Even if the notified body complies, the manufacturer must review its current contract to ensure that the new audit and documentation conditions are covered, and that the agreed timelines remain realistic under the new standards.

What should companies do now?

1. Identify the notified body you work with and verify whether it is designated under MDR (2017/745) and/or IVDR (2017/746), as only these are affected by Regulation 2026/977.
2. Contact the notified body to learn about its adaptation plan to the new quality management requirements and possible impacts on audit timelines and certificate renewal.
3. Review existing contracts with the notified body to identify whether the new operational conditions are contemplated or whether it is necessary to renegotiate terms.
4. Anticipate possible delays in ongoing certification or renewal processes, adjusting product launch plans if necessary.
5. Assess the risk of suspension of the current notified body and consider whether it is advisable to have an alternative identified, given that the capacity of notified bodies in the EU is limited.
6. Keep technical product documentation updated, as the new standards of notified bodies may require greater level of detail or new document formats in upcoming audits.