Spain Medical Device Registration

Understanding Medical Device Registration and Incident Reporting in Spain

Update on: 23/01/2024

Regulatory Authority: Spanish Agency for Medicine and Health Products (Agencia Española de Medicamentos y Productos Sanitarios or AEMPS)

The Spanish Agency for Medicines and Health Products (AEMPS) is a state agency under the Ministry of Health responsible for ensuring the quality, safety, efficacy, and correct information of medicines and products. It promotes scientific-technical knowledge and serves society for its benefit and progress.

The agency’s values include dedication to citizens, compliance with professional ethics, innovation, and commitment to quality, environment, and occupational health and safety. Services provided include evaluating, regulating, and monitoring medicines, controlling health products, and providing information about medicines.

The agency also fights against illegal and counterfeit medicines, manages drug supply, authorizes clinical trials, supports research, and coordinates the National Plan against Antibiotic Resistance.

Link for Regulatory Authority: https://www.aemps.gob.es/productos-sanitarios/productossanitarios_prodsanitarios/

Local Regulation: Royal Decree 437/2002, laying down the criteria for granting operating licenses to the manufacturers of medical devices (10 May 2002)

Classification: Class I, IIa, IIb and III 

Listing or Registration Requirements:

Documents Required:

1. Identifying data of the person making the communication.
2. Class to which the product belongs.
3. Trade name of the product in Spain and trade names under which the product is marketed in the European Union, if they are different from the first.
4. Category, type of product and model / s.
5. Description and intended purpose of the product.
6. Identification data of the manufacturer and the place of manufacture and its authorized representative, if applicable.
7. Identification number of the notified body or bodies that have intervened in the conformity assessment for the purposes of affixing the CE marking, applied annexes and copies of the CE certificates of conformity.
8. Labeling and instructions for use presented to or certified by the notified body.
9. Labeling and instructions for use with which the product will be marketed in Spain, as far as the Spanish version is not included in the information indicated in letter h). In this case, the Spanish version will be a faithful translation of those presented to or certified by the notified body.
10. Date on which it is marketed or put into service in Spain.
11. Identifying data of the distributors in Spain, in case they do not coincide with the person indicated in letter

Registration Timeline:  Immediately

• Registration Fee:
  Registration and reporting of medical devices – 99,71 €
• Authorization of clinical investigations of medical devices and performance evaluation studies of in vitro diagnostic medical devices – 553,51 €
• Substantial modification authorization of a clinical investigation of medical devices and performance evaluation studies of in vitro diagnostic medical devices – 543,73 €
• Import authorization of raw materials of human origin for the manufacture of in vitro diagnostic medical devices – 87,40 €
• Annual fee for maintenance of product information reported to the marketing registry – 59,83 €

License Validity: 5 Years

Special Labelling Requirements: The documentation required the notification submission must be provided both in the original language (CE certificate, labelling and User Manual), and translated into Spanish (labelling and User Manual only).

Incident Reporting:

You can report possible incidents that have occurred with medical devices, defined as any failure or problem that has occurred with a medical device, during its use or subsequently, and that may or may have had serious consequences for health.

The AEMPS records incidents to identify problems or defects in medical devices. This registry helps in case association, product failure indications, impact assessment, and rapid adoption of corrective measures, ensuring the safety and efficiency of medical devices.

• Information for patient incident reporting
• Information for reporting incidents by healthcare professionals

Additional Comments: A CE marking is a sign of compliance with the EU’s medical device regulations and ensures the effectiveness, safety, performance, and quality of the device. AEMPS can provide a medical device with a CE marking, which allows manufacturers to freely market their device within all countries belonging to EU. Under current regulations, a CE marking is generally valid for three years, although for medical devices associated with high risk this period is significantly shorter and is equal to only 1 year.

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

• Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk