In order to achieve EU MDR compliance, leveraging a Mexican Contract Manufacturing Organization (CMO) offers a strategic approach for medical device companies. By doing so, it combines cost-effective manufacturing with high-standard regulatory alignment.
Mexico, specifically, has included the EU MDR risk classification rules in its Supplement of Medical Devices since 2023. This facilitates the process of harmonizing production and getting access to the markets in Europe.
Harmonizing ISO 13485:2016 with EU MDR
Harmonizing the Quality Management System (QMS) using ISO 13485:2016 is the most effective way to get to the EU MDR compliance. The following are effective moves towards that goal:
- Risk Management. ISO 13485 emphasizes risk-based thinking; the EU MDR requires a life-cycle approach. The QMS must ensure that risk management is an ongoing process throughout the entire life of the product to ensure EU MDR compliance.
- Expand Post-Market Surveillance (PMS). The MDR (Article 83-86) requires a proactive PMS system that is more detailed than the feedback requirements in ISO 13485. You must establish formal PMS Plans and Periodic Safety Update Reports (PSURs) within your QMS structure.
- Clinical Evaluation. Clinical data requirements are significantly stricter under MDR. Your QMS must bridge the gap between design validation and the continuous clinical evaluation process mandated by the clinical evaluation process mandated by the Annex XIV.
- EUDAMED & UDI Readiness. EU MDR compliance requires the QMS to include procedures for Unique Device Identification (UDI) and data reporting to the EUDAMED database. These areas are not covered by the base ISO standard.
Other than these, attaining the compliance and certification milestones is also easier under the current framework.
Certification and Compliance
Following the Harmonized Standards list (which includes EN ISO 13485) simplifies the path to the CE Mark by providing a recognized benchmark for compliance. This is what is called Presumption of Conformity.
During conformity assessments, Notified Bodies will audit your QMS against both ISO 13485 and the additional specific requirements of the EU MDR.
Streamlining CE Marking for U.S.-Based OEMs
Streamlining CE Marking for U.S.-based OEMs involves identifying applicable directives, conducting risk assessments, ensuring technical documentation compliance, and utilizing U.S.-based accredited labs to test for CE compliance.
Utilizing third-party experts and specialized software allows the self-certification for many products or enables notified body involvement for high-risk equipment. Relying on Mexican manufacturers, moreover, can actually help access European markets.
The reason for this is that in 2023, the 5th Edition of the Supplement for Medical Devices of the Mexican Pharmacopoeia incorporated updated classification rules that align with the 22 risk-classification rules of the EU MDR 2017/745..
Key Steps for Streamlining CE Marking
In order to streamline the CE Marking for EU MDR compliance, it is advisable to follow the next steps:
- Identify Applicable Directives. Determine which of the 20+ directives apply to your product.
- Utilize U.S.-Based Labs. Many U.S. testing labs are accredited to test for European standards or are authorized by European Notified Bodies.
- Create a Technical File. Compile comprehensive documentation, including design, risk assessment, and test reports.
- Draft Declaration of Conformity. Formally declare that the product meets all EU requirements.
- Affix the CE Mark. Properly label the product for sale in 32+ countries.
Despite this, the experience may be different based on location.
Strategies for U.S. OEMs
U.S.-Based OEMs need to take a few additional steps to EU MDR compliance, such as:
- Leveraging Safexpert software or Similar Tools. Using specialized software for risk assessments and documentation to ensure conformity with directives, such as the Machinery Directive.
- Understanding Self-Certification. Determine if your product allows for self-certification or requires a third-party Notified Body.
For high-risk devices, such as medical equipment, different certification requirements apply under EU Regulation 2017/745 (MDR).
The CMO’s Role in EU MDR Compliance for Global Export
Under EU MDR 2017/74, the role of CMOs has shifted from simple suppliers to critical partners in regulatory compliance. It is their duty to provide evidence that their processes, QMS, and production adhere to strict traceable standards to ensure continued access to the European market.
Key Responsibilities of the CMO under EU MDR
CMOs must maintain a robust QMS, aligned with ISO 13485:2016 throughout the entire productive process. In the same way, they must maintain detailed and updated documentation to ensure full traceability of devices.
Not less important, they must participate in the risk management process and ensure that possible production risks are identified, controlled, and aligned with the legal manufacturer’s risk management file.
All processes must be validated and any changes to production must me managed through a formal change-control process, ensuring no new risks are introduced. CMOs must also be prepared for increased, often unannounced, audits by Notified Bodies for EU MDR compliance.
At last, CMOs must provide production records, non-conformance data, and complaint investigation results to the legal manufacturer to support their PMS and Post-Market Clinical Follow-up (PMCF) activities.
Impact on Global Export to the EU
Even during transition periods, manufacturers of devices (including legacy devices) must comply with MDR requirements regarding post-market surveillance. The EU MDR also requires that importers and manufacturer CMOs ensure that devices are correctly labeled with a UDI and conform to safety standards.
On the other hand, existing contracts must be updated to clearly define the responsibilities of the CMO regarding documentation. Lastly, manufacturers must ensure that agreements with CMOs include appropriate, updated liability and indemnity clauses to cover potential risks.
Advice for better CMO-Manufacturer Collaboration
A few steps to promote an effective collaboration for EU MDR compliance are:
- Outlining responsible parties for specific QMS elements.
- Performing regular audits of the CMO’s compliance with ISO 13485 and the specific requirements of the EU MDR.
- Implementing systems that allow for tracking from raw material to the final device.
- Ensuring all documentation is accessible for review.
- Establishing proactive communication regarding any potential non-conformances or supply chain disruptions.
Failure to ensure the CMO’s compliance can lead to delays, product recalls, and loss of access to the EU market. For this reason, by leveraging a Mexican CMO that complies with the EU MDR, manufacturers can transition, reduce costs, and maintain safety and quality standards for the EU market.
In RexMed, we specialize in medical devices from top OEMs by supporting innovation in the binational zone between Ciudad Juárez and El Paso. Our group offers end-to-end manufacturing through a vertically integrated chain of services.
