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MDR and IVDR CHANGES IN ISO 13485 QMS Changes that MDR and IVDR are causing in ISO 13485 QMS
All of us working in the Medical Device field are aware that the new regulations MDR and IVDR are bringing a series of significant changes to the various economic operators involved: manufacturers of medical devices, distributors, importers, authorized representatives, and notified bodies. However, the impact of these changes is more pronounced in some roles than others. For example, those responsible for Quality, Technical Managers, or Compliance Officers, face a significant challenge: being able to identify the change on one hand, and being able to implement it on the other within the required timeframe.

The quality management system or QMS (as it is known in English) is clearly affected by the MDR and IVDR regulatory modifications. It could be said that the processes of the quality management system are affected as the identification of the processes themselves, the technical documentation, and some specific aspects of certain devices change.

 
Changes that MDR and IVDR cause in QMS processes
With the modification of the regulations, changes are occurring in the Harmonized Standards that develop them, as well as in the Common Specifications specific to certain products. This means that the design, development, manufacturing processes, etc., affected by harmonized standards or technical specifications need to be modified. In fact, common specifications for non-medical products to which the MDR applies are expected to emerge in November 2021.

With the new regulations, the establishment of a compliance strategy is clearly required. In reality, it is not that it was not done until now, since the ISO 13485 itself establishes the need for identification and compliance with legal requirements, the issue is that now the law itself determines that it must be done. Therefore, the identification of legal and regulatory requirements, the strategy and planning (including resources and timelines) to meet them, must be perfectly defined.

The clinical evaluation and investigation processes have been much more defined, requiring all medical devices to undergo a clinical evaluation regardless of their class. It is true that clinical evaluation should not be confused with clinical investigation, that is, clinically evaluating a “Medical Device” means assessing with the available clinical data, either from published scientific literature or articles or reference opinions of similar products if the product is safe and functions as intended; while clinical investigation means conducting a clinical trial with people using the medical device to be tested to demonstrate that it is safe and functions as determined in its intended use.

MDR and IVDR determine the products that must definitely undergo a clinical investigation or clinical trial before being made available.

With the new regulations, an additional role is added to organizations: the compliance officer who will be responsible for identifying and verifying that all applicable legislation and regulations are complied with in the company, that QMS records are properly maintained, that the technical documentation is adequate, etc.

Additionally, the surveillance process of products in the market has been modified and now requires manufacturers to have strict control of post-marketing starting from the need to establish a post-marketing plan, and even a post-marketing clinical evaluation.

Furthermore, the communication between the different economic operators, users, customers, and competent authorities is defined, allowing all of them to report incidents or accidents with the medical devices used.

Finally, a European registration system for medical devices and everything surrounding them is defined and developed through the creation of a database called EUDAMED that will collect all the traceability of the product and all the agents involved in it.

{{SHORTCODE_0}} ISO 13485 Processes{{SHORTCODE_1}}
MDR and IVDR changes in technical documentation controlled by the QMS
The first basic element that has been modified by MDR and IVDR is the classification of medical devices. New classification rules and sub-rules have been incorporated, causing some devices that were classified as class I before the MDR came into force to now be classified as class IIa, for example, with all that this implies for manufacturers. Obviously, directly related to the change in classification is the change in the conformity assessment of the device. Now, reusable surgical instruments must assess their conformity through a Notified Body.

The regulations themselves identify specific procedures both for conducting the clinical evaluation and for developing the technical documentation. Both regulations establish exactly the parts and points in each part of the technical documentation of the product in question, as well as the need for a summary document of the “Technical File” or an index in each of the parts.

Labeling is another point modified with the new regulations. From their entry into force, the unique identification system or UDI is mandatory, which implies the need to establish a procedure for creating UDIs from the BASIC UDI-DI to the different UDIs by product and variants.

Additionally, the technical documentation for class IIb and III will contain a periodic safety update report (PSUR) updated at least annually. Class IIa must also have a PSUR updated at least every two years, although it is not specified that it must be part of the technical documentation. In the case of class III and implantable products, the PSUR must be available in EUDAMED, when possible. Additionally, implantable products and class III products that are not custom-made or under investigation must have a summary of safety and clinical performance (SSCP as it is known in English) that will be part of the technical documentation and will be validated by the corresponding Notified Body.

Finally, all technical documentation must reflect the changes the device undergoes, not becoming obsolete, and must remain in continuous renewal and updating.

{{SHORTCODE_2}} Technical Documentation{{SHORTCODE_1}}
MDR and IVDR changes in non-medical purpose products
IVDR and MDR have considered that certain products, either because of their intended use, their raw materials, their development processes, or how they are to be composed and used, must be considered special. To begin with, the famous Annex XVI for non-medical purpose products is added.

Now, many aesthetic products that were not previously under the umbrella of medical device regulation are now included.

There is talk of medical devices manufactured with nanoparticles, with animal or human-derived tissues, medical devices containing drugs, software specified as a medical device, treatment of parts or components of medical devices, and systems or kits for procedures. All of this with specific actions and requirements to be met depending on the product being manufactured, imported, distributed, or represented.

{{SHORTCODE_4}} Non-medical purpose products applied by the MDR{{SHORTCODE_1}}