Medical Devices
European Regulation of Medical Devices. Compliance with requirements for placing medical devices on the market.
The complexity of the European regulatory framework poses continuous challenges to the involved stakeholders, compounded by the innovation and variety within the sector, which requires companies to stay constantly updated.
The term “Medical Device” refers to a wide range of products that play an essential role in healthcare and serve to improve treatments and the quality of life of individuals or patients in need.
These products are characterized by the obligation to comply with regulatory requirements that enable them to bear the CE marking, indicating compliance with Medical Devices regulations.
At CARJES SOLUCIONES, we assist companies in complying with regulatory requirements for placing their medical devices on the market according to EU Regulation 2017/745. From managing the Notified Body (selection and request for quotation), through selecting the conformity assessment route and preparing all technical documentation, to obtaining the CE marking. We accompany you through all stages of the regulatory process to provide solidity and consistency at every step.
Innovation is the backbone of our consultancy. We work closely with clients who lead the way in developing innovative medical devices. From cutting-edge products to solutions that exceed expectations, we strive to be pioneers in adaptability, ensuring that our clients stay one step ahead in an ever-evolving market. Our expertise extends to products with CMR substances (Carcinogenic, Mutagenic, or Toxic to Reproduction), animal-origin products, as well as software and electromedical products.
CE Marking
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:
- Description and specifications of the product.
- Reference to previous generations and similar products.
- Product accompanying information.
- Information about design and manufacturing.
- Evidence of compliance with general safety and performance requirements.
- Risk assessment, benefit/risk analysis, and risk management.
Verification and validation of the products.
- Preclinical and clinical evaluation.
- Post-market surveillance and vigilance system.
Risk Management Process
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.
Software Medical Devices (MDSW)
Software medical devices (MDSW) have gained significant volume and relevance in the global market of medical devices, becoming increasingly important and influential in advancing healthcare through disease prevention, diagnosis, and treatment.
The rise of software medical devices is closely linked to the application of artificial intelligence in the healthcare sector, bringing forth new opportunities for companies in both the traditional software sector and the healthcare sector.
A software medical device (MDSW) is understood to be software intended for use alone or in combination with other products, whose intended purpose aligns with the definition of medical devices indicated in the regulations of medical devices EU 2017/745 and in vitro diagnostic medical devices 2017/746. This includes both software integrated into medical devices and standalone or autonomous software.
At CARJES SOLUCIONES, we specialize in software medical devices (MDSW), assisting our clients in understanding and complying with the specific requirements applicable to these products, covering the entire lifecycle from early design and testing phases to verification, validation, and maintenance.
Clinical Evaluation of Medical Devices
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.
Validation of Usability
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.
Post-Market Surveillance
The process of market monitoring and surveillance has undergone a complete turnaround. Reactive monitoring of the performance of medical devices in the market is no longer sufficient. The new regulatory framework clearly establishes all requirements related to post-market surveillance activities for manufacturers, importers, and distributors of medical devices. At CARJES SOLUCIONES, we assist you in designing and planning all post-market surveillance activities according to the relevant MDCG guidelines and ensure that all reports are completed in a timely manner, according to the established periodicity for product classification, throughout the product’s journey in the market.
- Articles 78 to 81, Annex III, and Annex XIII Part B for Regulation EU 2017/746.
- MDCG Guidelines
Licenses
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.
+34 916 33 51 18
Contact us
We help you in everything you need develop a work plan with your company.
How may we help you?
Our experience is always at the service of our clients and their needs.
Experts Professionals
Consultancy specialized in medical devicess, biocides and food and nutritional supplements.