Medical Devices

The CE marking is the means by which the manufacturer of medical devices demonstrates that a product complies with the General Safety and Performance Requirements of the relevant European Regulations for Medical Devices.
A medical device can only be introduced to the market or put into service if it complies with the provisions of the applicable Regulation, provided it is properly supplied and installed, maintained, and used in accordance with its intended purpose.
It is primarily the responsibility of the manufacturer, but also the responsibility of the authorized representative, importer, and distributor. All must ensure that they place a safe product on the market for the end user.

The demonstration that a product meets the general safety and performance requirements is carried out through technical documentation, which includes:

1. Description and specifications of the product.
2. Reference to previous generations and similar products.
3. Product accompanying information.
4. Information about design and manufacturing.
5. Evidence of compliance with general safety and performance requirements.
6. Risk assessment, benefit/risk analysis, and risk management.

Verification and validation of the products.

• Preclinical and clinical evaluation.
• Post-market surveillance and vigilance system.

The risk management process, coupled with a robust approach to identifying the applicable general safety and performance requirements for the medical device, is one of the key elements for achieving a successful conformity assessment process. We have a multidisciplinary team that, in collaboration with the manufacturer’s proposed team, will develop a risk management process in accordance with the policies established in both regulations.

• Sections 3 and 4 of Annex I of Regulation (EU) 2017/746
• EN ISO 14971:2019/A11:2021.

According to the definition in Regulation EU 2017/745, clinical evaluation is a systematic and planned process for generating, collecting, analyzing, and continuously evaluating clinical data related to a product to verify its safety and performance, including clinical benefits, when used as intended by the manufacturer.

While clinical evaluation was already a requirement, the regulation introduces significant novelties to it. It is a more complex process with different pathways available depending on the level of innovation, intended use, technology, preclinical and clinical data, and equivalence requirements between medical devices.

These circumstances are generating a high volume of Non-Conformities during the clinical evaluation review process carried out by Notified Bodies.

At CARJES SOLUCIONES, we offer our clients our experience in conducting clinical evaluation plans and reports following the current versions of applicable guidelines and complying with the requirements established in:

• Article 61 and Annex XIV Part A of Regulation EU 2017/745.

One of the main intrinsic characteristics inherent to the nature of medical devices is their usability. Usability is the characteristic of the user interface that facilitates usage and, therefore, establishes effectiveness, efficiency, and user satisfaction in the intended use environment. With the entry into force of the new regulatory framework, usability becomes a fundamental aspect of medical devices to be verified and validated along with accompanying information. We have extensive experience in the design, planning, and validation process of usability for all types of products, in accordance with the relevant standard.

• EN 62366:2015/A1:2020.

With the issuance of the new Royal Decree 192 of March 21, 2023, the requirement to obtain prior operating licenses for importation, grouping, manufacturing, and third-party sterilization activities remains unchanged. At CARJES SOLUCIONES, we assist you during the processes of obtaining, renewing, or modifying these types of licenses, preparing and processing all documentation processes through the IPS platform of the Spanish Agency of Medicines and Medical Devices (AEMPS).

Additionally, we handle the communication of market placement for Class B, C, and D marketed products through the CCPS platform of the AEMPS. We register Class A products manufactured in Spain through the dedicated RPS platform of the AEMPS.

Finally, we offer the service of Technical Responsibility for the 4 activities covered in Royal Decree 192 of March 21.