Are you ready for the new regulation on In Vitro Diagnostic medical devices in Spain? Learn everything you need to know about it.
The in vitro diagnostic medical device sector plays an important role in healthcare by providing instruments and solutions for illness diagnosis and monitoring. Regulatory agencies regularly update and adopt new regulations to maintain the safety and effectiveness of these products.
Recently, the public consultation process for the new regulation on In Vitro diagnostic medical devices in Spain, replacing the previous Royal Decree 1662/2000, has been completed.
The proposed text’s draft can be accessed on the website of the Spanish Ministry of Health. The new decree aims to adopt the required regulatory measures in areas where Regulation (EU) 2017/746 allows member states to establish national regulations.
These regulations address key aspects such as manufacturer licensing, clinical studies, and the production of in vitro diagnostic devices for exclusive use in healthcare facilities.
New Regulation on In Vitro Diagnostic Medical Devices: 5 Key aspects
1. Operating License
The new regulation on In Vitro diagnostic medical devices, like the previous one, requires manufacturers, importers, and now those who make finished products for third parties to get a prior operating licence.
To assure product quality and the execution of key procedures and controls, manufacturers must have a quality management system in place. They must also have suitable facilities, procedures, equipment, and personnel for the corresponding activities and products.
The new regulation maintains the figure of the technical responsible person, who must have a minimum higher education degree.
Although the requirements and duties of the technical responsible are not the same as those of the personnel responsible for regulatory compliance as set out in Regulation (EU) 2017/746, they may be covered by the same person if they meet all the requirements.
2. Registration and Marketing Obligations
The second key aspect of the new regulation for In Vitro diagnostic medical devices makes a reference to registration and marketing obligations.
Before beginning their activities, any economic operator seeking to market products in Spain has to register in the Commercialization registration of the Spanish Agency of Medicines and Medical Devices.
Economic operators must keep written records of the products they make available in Spain and must notify the regulator of any changes in this information or cessation of activity. This registration is required to assure the traceability and safety of the product.
Economic operators must disclose information in Spanish if health authorities make a justified request, but they may submit documentation in other languages to demonstrate product conformity. Importers and distributors must get the necessary documentation from the manufacturer or authorised representative if it is not available.
The new regulation for in vitro diagnostic medical devices mandates the creation of a document archive system to store the documentation generated for each product and to keep a record of all products for traceability purposes.
Manufacturers must make the records available to relevant authorities for at least ten years following the product’s last market release, even in extreme situations such as bankruptcy or the suspension of business.
These requirements ensure that manufacturers maintain rigorous control over the quality and safety of their products and facilitate supervision by authorities. It is important to note that some of these obligations do not apply to pharmacies, as they have their own records.
3. In-House Product Manufacturing
The manufacturing of in-house products in health institutions is subject to strict regulations under the new regulation for in vitro diagnostic medical devices to ensure product safety and quality. In line with Regulation (EU) 2017/746, the new text recognizes that all health institutions can carry out the manufacturing of in vitro diagnostic devices for exclusive use within those centres, not limited to hospitals as it is the case with medical devices.
However, to do so, they must comply with all the requirements established in Article 5(5) of the Regulation (EU) 2017/746. It is important to mention that health institutions cannot subcontract manufacturing outside Spanish territory.
Additionally, they must designate a responsible person for manufacturing procedures and communicate their data to the Spanish Agency of Medicines and Medical Devices. This ensures traceability and regulatory compliance in the manufacturing process.
The sale of products manufactured in these centres to the public or third parties is not permitted. Moreover, health institutions must provide prior communication of the start of manufacturing activities, providing detailed information and complying with the required documentation.
The agency can conduct subsequent verifications and inspections to ensure compliance.
4. Performance Studies
The new regulation for in vitro diagnostic medical devices addresses the requirements and procedures related to clinical performance studies in the field of in vitro diagnostic medical devices. Ethical and subject protection principles must apply to these studies.
Products intended for clinical performance evaluation studies must receive approval from the Research Ethics Committee and the centre’s management before they can begin. Interventional clinical performance studies and other functional performance studies involving risks to test subjects require authorization from the AEMPS (Spanish Agency of Medicines and Medical Devices).
The text establishes provisions regarding documentation, product supply, insurance, compensation for damages, and liability regime for sponsors.
5. Market Surveillance and Control
The system of market surveillance and control is essential for ensuring the safety and quality of in vitro diagnostic medical devices according to the new regulation for in vitro diagnostic medical devices.
Manufacturers, healthcare professionals, authorities, and users play a crucial role in this process, working together to protect public health and ensure regulatory compliance.
Manufacturers must report incidents in accordance with established protocols. Additionally, healthcare professionals, authorities, and users have the responsibility to report serious incidents to the Spanish Agency of Medicines and Medical Devices. Health institutions must designate a surveillance responsible person and communicate their data to the relevant health authorities.
Manufacturers must also report safety corrective actions and provide information in Spanish to ensure effective dissemination. The Spanish Agency of Medicines and Medical Devices coordinates market control activities in collaboration with regional health authorities, including periodic inspections.
Other specific aspects and details are regulated by this regulation, such as the use of products that have not yet demonstrated conformity or aspects related to genetic testing.
It is important underlying the significance of regulatory compliance and quality in the manufacture of these products, as well as how a regulatory, quality, and clinical consultancy service organisation may be a strategic ally in this highly regulated and ever-changing environment.
We must be prepared to comply with the royal decree once the parliamentary procedures are concluded and the new regulation for in vitro diagnostic medical devices is authorised.
How can MDx CRO help?
Are you finding it challenging to navigate the complexities of the new in vitro diagnostic medical device regulations in Spain? Is the realm of IVD consulting seeming increasingly vital to your business? Look no further than MDx CRO, your dedicated partner in this journey.
With a team of experienced IVD consultants, we provide robust solutions for regulatory, quality, and clinical consultancy services tailored to your needs. As your IVD consultancy partner, we offer comprehensive assistance in manufacturer licensing, clinical studies, and production compliance, ensuring your business aligns seamlessly with the new Royal Decree and Regulation (EU) 2017/746.
Don’t let regulatory hurdles stand in the way of your company’s success. Embrace the change, and navigate this evolving landscape with confidence and ease by leveraging MDx CRO’s expertise.
For a no-obligation discussion on how we can assist you in maintaining your market competitiveness within the IVD sector, contact us today. Let us be your strategic ally in this highly regulated environment, ensuring your continued growth and success.