In Vitro Diagnostic Products
European Regulation on In Vitro Diagnostic Medical Devices. Compliance with requirements for placing medical devices on the market
The European Regulation concerning In Vitro Diagnostic Medical Devices requires compliance with requirements for launching of medical devices on the market. The intricate nature of the European regulatory landscape presents ongoing challenges for professionals involved in this sector. . This, along with the sector’s continual innovation and diversity, demands that companies remain consistently updated.
The term “In Vitro Diagnostic Medical Device” covers a broad spectrum of products crucial for healthcare. These products play a vital role in enhancing treatments and the quality of life for individuals in need. Notably, they are distinguished by their obligation to adhere to strict regulatory requirements, enabling them to bear the prestigious CE marking certifying their conformity with Medical Device regulations.
At CARJES SOLUTIONS, we assist companies in compying with regulatory requirements for the introduction of their in vitro diagnostic medical devices, as outlined in EU Regulation 2017/746. Our services encompass managing the Notified Body, including selection and quotation requests, selecting the conformity assessment route, and preparing all technical documentation necessary for obtaining the CE marking. Throughout the regulatory process, we provide comprehensive support to our clients, ensuring solidity and consistency at every step.
Innovation is the cornerstone of our consultancy approach. We closely collaborate with clients at the forefront of developing innovative medical products, ranging from cutting-edge technologies to solutions that surpass expectations. We aim to lead in adaptability, ensuring our clients maintain a competitive edge in an ever-evolving market. Our expertise spans various types of products, including Class A, B, C, and D, as well as software products.
CE Marking
The CE marking seris the evidence that a medical device manufacturer complies with the General Safety and Performance Requirements specified…
CE Marking
The CE marking seris the evidence that a medical device manufacturer complies with the General Safety and Performance Requirements specified in relevant European Medical Device Regulations. A medical device can only be placed on 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 correctly according to its intended purpose.
While the primary responsibility lies with the manufacturer, all entities within the distribution chain share the responsibility to ensure the safe placement of products for patients and end-users. Demonstrating compliance with general safety and performance requirements involves the preparation of technical documentation, which includes:
- Product description and specifications.
- Reference to previous generations and similar products.
- Product accompanying information.
- Details on design and manufacturing.
- Evidence of compliance with General Safety and Performance Requirements.
- Risk assessment, benefit/risk analysis, and risk management.
Product verification and validation, encompassing:
a. Information on analytical performance.
b. Details on clinical performance and clinical trials, including a performance evaluation report.
c. Stability assessment. d. Verification and validation of software programs.
Risk Management Process
The risk management process, combined with a robust approach to identifying the general safety and ...
Risk Management Process
The risk management process, combined with a robust approach to identifying the general safety and performance requirements applicable to the medical device, is crucial for a successful conformity assessment process. Our multidisciplinary team, collaborating with the manufacturer’s proposed team, will develop a risk management process aligned with the policies outlined in both regulations.
- This process is guided by Sections 3 and 4 of Annex I of EU Regulation 2017/746, as well
- as EN ISO 14971:2019/A11:2021.
Performance Assessment
The performance assessment process introduces innovations compared to previous regulatory frameworks…
Performance Assessment
The performance assessment process introduces innovations compared to previous regulatory frameworks. These processes are intricate, offering various routes based on the level of innovation, classification, and market experience of the product. These factors often lead to a high volume of Non-Conformities during the clinical evaluation of products by Notified Bodies. Our comprehensive service ensures compliance with the requirements outlined in both regulations.
- This process is governed by Article 56 and Annex XIII Part A of EU Regulation 2017/746.
Usability Validation
Usability is a key intrinsic characteristic of medical devices, influencing effectiveness, efficiency, and user satisfaction...
Usability Validation
Usability is a key intrinsic characteristic of medical devices, influencing effectiveness, efficiency, and user satisfaction. With the implementation of the new regulatory framework, usability becomes a fundamental aspect to be verified and validated alongside accompanying information. We possess extensive expertise in designing, planning, and validating usability for all product types, adhering to the
- EN 62366:2015/A1:2020 reference standard.
Post-Market Surveillance
The market monitoring and surveillance process have undergone a significant transformation. …
Post-Market Surveillance
The market monitoring and surveillance process have undergone a significant transformation. Reactive monitoring of a medical device’s performance in the market is no longer considered sufficient. The new regulatory framework comprehensively outlines all requirements pertaining to post-market surveillance activities for manufacturers, importers, and distributors of medical devices.
At CARJES SOLUTIONS, we assist in designing and planning all post-market surveillance activities according to reference MDCG guides. We ensure that all reports are conducted in a timely manner, following the established periodicity for product classification, throughout the product’s journey in the market.
- This process is governed by Articles 78 to 81, Annex III, and Annex XIII Part B of EU
- Regulation 2017/746, as well as relevant MDCG guides.
Licenses
With the new draft Royal Decree governing in vitro diagnostic medical devices, specific provisions, in particular…
Licenses
With the new draft Royal Decree governing in vitro diagnostic medical devices, specific provisions, in particular:
a) The competent authority and health guarantees.
b) Procedures for granting prior operating licenses for facilities.
c) Consideration of genetic tests as in vitro diagnostic medical devices for human use, in line with the definition set out in Article 2(2) of Regulation (EU) 2017/746.
d) Reference laboratories.
e) The requirements and actions of notified bodies.
f) Marketing and placing into service in Spain.
g) Intra-community and external trade.
h) Performance studies.
i) Surveillance system.
j) Market inspection and control and health protection measures.
At CARJES SOLUTIONS, we provide comprehensive support throughout the processes of obtaining, renewing, or modifying these types of licenses. We handle all documentation processes through the AEMPS IPS platform.
Additionally, we manage the communication of placing on the market for class B, C, and D products manufactured and imported via the AEMPS CCPS platform. Furthermore, we register class A products manufactured in Spain using the dedicated AEMPS RPS platform.
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Consultancy specialized in medical devicess, biocides and food and nutritional supplements.
C/ Puerto de los Leones 2, Planta 2. Oficina 12. 28220. Majadahonda. Madrid.
