Medical devices: licences, registrations, and documentation

Oversight of activities related to medical devices to ensure regulatory compliance.
Verification of conformity for products manufactured, imported, bundled, sterilised, or distributed.
Review of technical files and regulatory documentation.
Incident management through the vigilance system.
Oversight of implant cards for applicable products.
Collaboration and acting as the point of contact with health authorities.
Preparation and oversight of marketing notifications and registrations of market operators.
Coordination of authorisations for clinical trials and clinical investigations.
Review and approval of advertising and marketing content for legal compliance.

For manufacturers: compliance with essential requirements and applicable testing.
For assemblers: verification of CE marking and compliant documentation for the final product.
For sterilisation providers: validation of procedures and compliant batch release.
For importers: ensuring documentation, warnings, and specific requirements for the destination market.

This licence allows companies to import medical devices from outside the European Union. Currently, with this licence you can import any type of medical device (from a non-sterile Class I to a Class III). It is a very useful licence to import your product into Spain as quickly as possible, as the process of obtaining it and the procedure to bring your product in does not require as much documentation and time as other licences.

This licence allows companies to manufacture medical devices. With the application and approval of the licence issued by the AEMPS (Spanish Agency of Medicines and Medical Devices), any medical device may be manufactured provided that documentary requirements, quality certification, facilities, and personnel requirements are met. At Medical Devices Sur Consulting, we support you in managing and obtaining the licence and in subsequent follow-up to meet the guarantees for manufacturing and marketing the medical device.

This licence allows you to bundle medical devices on an individual basis. This is what is commonly known as first-aid kits, surgical kits, or analytical parameter measurement kits such as glucose. Unlike the manufacturing licence, there are certain specific requirements, such as the need to prepare a compatibility declaration, among others.

Allows the distribution and marketing of medical devices nationwide, acting as an intermediary between distributors or customers. It is requested from the regional health authority where the distribution warehouse is located, regardless of where the registered office is. For example, if the warehouse is in Catalonia, the application must be submitted there. Compared to other licences, the procedure is simpler and less costly.

With the application of the new Regulation 2017/745, manufacturers, European authorised representatives, and importers must register on the European EUDAMED platform. EUDAMED is the new European portal whose main function is to serve as a database and consultation tool for all medical devices and the actors involved in their marketing. The assurance provided by this platform is that, prior to registration, it has been verified that both the medical devices and the actors meet the legal requirements to market the medical device; therefore, registration on this platform ensures that medical devices and actors comply with all legal and health guarantees required to be marketed in the European Union.

EUDAMED has 6 modules: actor registration module, product registration module, product-related certificate registration module, vigilance module, clinical investigation module, and post-market module.

Medical Devices Sur Consulting provides comprehensive support throughout the import, manufacturing, bundling, and distribution process for medical devices. We specialise in delivering effective solutions for companies in the sector, ensuring quality and efficiency at every step of the process.

The Basic UDI-DI is a code that must appear in a product’s Declaration of Conformity and identifies the manufacturer, manufacturing method, and the medical device family, linking it to other products with the same intended medical purpose, risk, or manufacturing method.

Identification code for the model and manufacturer. It is known as the static part of the code because, as a general rule, it does not change except in specific cases.

Identification code for the manufacturing/expiry date and the product batch number. It is known as the dynamic part of the code because it changes with each production batch.

The PSUR is a more comprehensive post-market report that requires more data on the actors involved in the product, the product itself, associated risks, corrective actions taken, and the product’s target population. It must be prepared in accordance with the guidelines established by the MDCG (Medical Device Coordination Group) and must be updated at least every two years for a Class IIa device and at least annually for a Class IIb and Class III medical device. It must then be submitted in the EUDAMED electronic system, specifically in the post-market module.

At Medical Devices Sur Consulting, we can provide the clinical investigation service. The procedures to follow to carry out the clinical investigation are summarised as follows:

Planning and design of the research project. Clinical investigations must be conducted according to an appropriate investigation plan, using the procedures and methodologies necessary to confirm the manufacturer’s claims regarding the safety, performance, and benefit-risk ratio of the device.

Preparation of documentation related to the clinical investigation application. The documentation required to conduct a clinical investigation includes the Clinical Investigation Plan (protocol), the Investigator’s Brochure, and other documents containing information on matters such as compliance with general requirements and the measures adopted to comply with applicable personal data protection and confidentiality rules.

Regulatory affairs with CEICs, AEMPS, and centres. To start a clinical investigation in Spain, it is mandatory to have:

• Authorisation from the AEMPS.
• A favourable opinion issued by a Research Ethics Committee with medicines (CEIm).
• Approval from the management of the participating centre (contract).

Study coordination and monitoring. The coordination, follow-up, and monitoring of the clinical investigation are essential to ensure that the study is conducted in accordance with the Clinical Investigation Plan and in line with the principles of Good Clinical Practice and the Regulation.

Database creation and statistical analysis. A robust database is essential in clinical investigations with medical devices. A well-designed database ensures that the collected data are:

• Consistent (structured uniformly).
• Accurate (without errors or duplicates).
• Complete (without gaps).
• Relevant (aligned with the study objectives).

This is key to obtaining scientifically valid conclusions on the medical device’s efficacy, safety, and performance.

In addition, health authorities require rigorous databases for audits and regulatory assessments, and the implementation of the necessary access control and encryption measures to comply with regulations such as the GDPR.

Final clinical investigation report. The clinical investigation report will contain the results of the statistical analysis and their critical interpretation, and will form part of the device’s clinical evaluation and the documentation required for the CE marking application.

In addition, as part of the scientific rigour involved in conducting clinical investigations on medical devices, activities are carried out such as registering the clinical investigation in publicly accessible registries, preparing communication plans for conferences, and publishing in scientific journals.

Request information with no obligation about our clinical investigation service and place your trust in professionals with more than 25 years of experience in the field of clinical research.