AEMPS Services Charter 2026-2029: What Changes for Medical Device Manufacturers

Key data

If your company manufactures, imports or distributes medical devices in Spain and works with the AEMPS (Spanish Agency for Medicines and Medical Devices), this resolution directly affects you. As of October 3, 2026, the National Center for Certification of Medical Devices operates under a renewed Services Charter that establishes formal quality commitments for the period 2026-2029.

The Resolution of September 22, 2026, approved by the Under-Secretary of Health, updates this document in accordance with Royal Decree 951/2005 on quality improvement in the General State Administration. What is relevant for companies in the sector is not the administrative procedure itself, but what it implies: the deadlines, procedures and service standards that the certification body is obliged to meet and that companies can demand.

What does this regulation establish?

A Services Charter is an official document through which a public body formally commits to citizens and companies regarding the quality of its services. In this case, the National Center for Certification of Medical Devices of the AEMPS renews its commitments for the four-year period 2026-2029.

The key elements regulated by this update are:

• Service commitments: quality standards that the AEMPS commits to meet in its certification processes.
• Response deadlines: maximum processing times that the body assumes for sector requests.
• Processing channels: enabled channels to interact with the Center, which may have been updated from the previous period.
• Document availability: the Charter must be accessible at the following points:

The regulatory framework that enables this Charter is Royal Decree 951/2005, which regulates the general framework for quality improvement in the General State Administration and requires public bodies to periodically review and update these commitments.

Economic and operational impact

This resolution does not generate direct costs or additional fees for companies. Its impact is mainly operational and strategic: it defines the rules of the game in the relationship between the sector and the certification body over the next four years.

The practical effects for companies in the sector are:

• Possible changes in certification deadlines: if the new Charter modifies the committed response times, this directly affects product launch planning and inventory management.
• New or modified processing channels: the update may involve changes in the procedures for submitting documentation, with impact on internal administrative resources.
• Formal complaint tool: the commitments in the Charter are enforceable. If the AEMPS does not meet them, companies have documentary basis to file complaints or escalate incidents.
• Planning 2026-2029: knowing the committed standards allows manufacturers and importers to better size their certification and market launch processes.

Who does it affect?

• Medical device manufacturers that require certification or interaction with the AEMPS National Center for Certification.
• Medical device importers operating in the Spanish market and processing documentation with the AEMPS.
• Medical device distributors with registration or notification obligations to the body.
• Regulatory advisors and Regulatory Affairs departments of healthcare sector companies managing files with the AEMPS.
• Operations directors and supply chain managers whose planning depends on the body's certification deadlines.

Practical example

A manufacturer of in vitro diagnostic material plans to launch a new product on the Spanish market in the first quarter of 2027. To do so, it needs to process the corresponding documentation with the National Center for Certification of Medical Devices of the AEMPS.

With the new Services Charter 2026-2029 in force as of October 3, 2026, the Regulatory Affairs team of this company can:

1. Consult the response deadlines committed by the AEMPS on the Center's website or the General Access Point, and use them as a basis for launch planning.
2. Verify if the processing channels have changed from the 2022-2025 period, to adapt its internal documentation submission procedures.
3. In case the AEMPS exceeds the deadlines committed in the Charter, have an official document to support a formal complaint, avoiding unmanaged delays in the launch.

This type of proactive planning, based on the formal commitments of the body, can make the difference between a timely launch and one delayed by unanticipated administrative incidents.

What should companies do now?

1. Download and review the new Services Charter 2026-2029 available on the National Center for Certification of the AEMPS website, the General Access Point or the Transparency Portal. Identify the deadlines and commitments that affect your usual procedures.
2. Compare with the previous Charter to detect changes in response deadlines, procedures or processing channels. Any modification may require adjustments to your internal processes.
3. Update certification planning for the 2026-2029 period incorporating the new deadlines committed by the AEMPS as a reference in your launch and renewal calendar.
4. Inform Regulatory Affairs, operations and supply chain teams about changes in channels and procedures to avoid processing errors that generate delays.
5. Document any AEMPS non-compliance with the Charter commitments, as this document has formal value for complaints to the body.

Official source

Consult complete regulation in official source

Notice: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2026-20517