
The European Union Medical Device Regulation (MDR) of 2017 that will take effect from May 26 will pose huge challenges for the medical device manufacturers. This new regulation that replaces the EU’s Medical Devices Directive (MDD) covers all the new medical devices that are produced in the European Union and supplied to the countries in the EU.
Section 10.4 of the new regulation describes the use of Category I Carcinogenic, Mutagenic or Toxic for Reproduction (CMRs) and Endocrine Disrupting Chemicals (EDCs). It states that the use of such substances is restricted unless a justification is accepted. This change creates a huge challenge for medical device manufacturers who are now looking for alternate methods to manage material information to understand the restricted substances.
We will look into a few of the best practices that medical device manufacturers can use to manage material information. Let’s also check out the ways in which your enterprise will benefit by using a consolidated system to manage material information in compliance with the regulations of the section 10.4.1 of MDR.
The Section 10.4.1 of MDR states that “CMRs Category I and EDCs cannot be present in more than 0.1% weight by weight (w/w) when in direct contact with patients or in contact with solids, fluids or gases that are administered or re-administered to patients.”
However, if a manufacturer can prove that the use of such a substance is justified based on its benefit for the patient, then this restriction can be removed.
To ensure better compliance of the regulation, we need to understand what kind of materials and substances information need to be gathered. It’s therefore important to establish an organization-wide approach to managing substance and material information so as to reduce the risks. This approach also helps speed up the product design and approval process.
The wide range of properties and linked network of the materials and substances used in medical device manufacturing make it more challenging to ensure compliance. It’s possible to reliably quantify the restricted substances by correctly mapping and tracing the link of the networks. A complication in the mapping process is that some of the substances used in the manufacturing process may not be a part of the final product. Though the substances are not a part of the final product, it’s important to track and trace them to ensure complete MDR approval. Also, while evaluating the substances, we should also take into account the human body contact in the manufacturing process. It’s also an essential step in identifying and reporting the substance information for devices approval.
Centralize to Comply
This new regulation of the MDR is a huge challenge for medical device companies. However, companies can use the same information to show compliance to California Proposition 65, EU’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and other important regulations and legislations. When all the data is brought into a centralized model, compliance reporting can be done independently. In order to ensure the correct capture and management of all the information, it’s vital to accurately identify the restricted materials. Late identification of the use of a non-compliant material could lead to several manufacturing delays and quality issues down the production line. Therefore, it’s necessary to correctly identify the materials in the initial stage of the production process itself.
Medical device manufacturing companies use multiple systems such as product lifecycle management (PLM) and computer-aided design and engineering (CAD and CAE) to design new products. Manufacturers using multiple substances and materials in the production process can use a database solution like the Ansys Granta MI. This commercial off-the-shelf system offers a cost-effective and efficient solution to manage and track materials information and analyze compliance. This database has the updated data of the latest changes in the regulations. Plus, it easily integrates with the existing systems.
A few of the key features of the Granta MI materials database solution are:
- Availability of updated reference data of the latest changes in the regulations
- Enables fast assessment of compliance of the new and existing products with the regulation
- Fills the knowledge gap with reference to substances and materials data so as to assess the risk, especially where the supplier data is not available
- Collate all the materials and substances information in one centralized system, which can be accessed by the relevant departments and teams for accelerated product design and development
- Integrate the design tools with the material data management system to ensure traceability and consistency
- Consider compliance conformation during the design process to reduce expenses and ensure compliance from the initial stage itself
Talk to us to know more about Granta MI and how you can effectively leverage this solution to ensure compliance with the new EU Medical Devices Regulations.
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