Lesson 8 – Systematic Literature Review Course: Are You a Qualified Reviewer?

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What Do Meddev and MDR Say About Qualifications for Reviewers?

As part of the EU MDR (European Union Medical Device Regulation) compliance process, ensuring that your clinical evaluations and literature reviews are conducted by qualified reviewers is crucial. But what exactly makes a reviewer “qualified”? This blog post will help you understand the qualifications needed and how to manage potential conflicts of interest, whether you handle reviews internally or outsource the process.

The Role of Qualified Reviewers under EU MDR

Under the EU MDR, companies are not necessarily required to outsource clinical evaluations and literature reviews. However, the reviewer must meet specific qualifications to ensure the integrity and thoroughness of the evaluation. According to the EU MDR and the MEDDEV 2.7/1 rev 4 guidance document, the qualifications for reviewers are clearly outlined.

Qualifications Required for Reviewers

To be deemed qualified under the EU MDR, reviewers must have documented evidence of relevant scientific, clinical, or regulatory expertise. Key qualifications include:

• Higher Education Degree: A relevant degree in a scientific, clinical, or regulatory field.
• Substantial Experience: Significant experience in medical writing and understanding clinical methodologies.
• Regulatory Knowledge: A thorough understanding of regulatory requirements related to medical devices.

Reviewers should also possess knowledge specific to the device being evaluated, including:

• Device Technology: Understanding the technology and application of the device.
• Clinical Knowledge: Familiarity with the conditions the device diagnoses or treats, as well as medical alternatives.

Managing Conflicts of Interest

Conflict of interest (COI) is a crucial consideration when selecting reviewers. If an internal employee has a financial stake in the success of the device, their impartiality could be compromised, and it might be more prudent to hire a third-party reviewer to ensure unbiased evaluation.

• Internal vs. External Review: If the reviewer has a vested interest in the device’s commercial success, it is recommended to hire an external reviewer. A Declaration of Interest (DOI) statement should be attached to the review to disclose any potential conflicts.

Choosing the Right External Reviewers

If outsourcing is necessary, it’s essential to choose external reviewers or consulting firms that have no financial interest in the device’s commercial success. Here’s what to look for when hiring external reviewers:

1. Impartiality: Ensure they are free from any conflicts of interest.
2. Experience and Qualifications: Look for reviewers with relevant regulatory and clinical experience.
3. Documentation: Always ensure that a DOI statement is attached to the review documents to maintain transparency and credibility.

Credentials and Accreditations of Reviewers

While there are no mandatory accreditations required by the EU MDR, reviewers who are affiliated with recognized medical or regulatory bodies bring added credibility to the evaluation process. Additionally, ongoing training in the latest regulatory changes is beneficial for maintaining compliance.

Internal Review vs. Outsourcing: What’s the Best Approach?

• Internal Review: Companies can handle reviews internally as long as the reviewers meet the required qualifications. This can be cost-effective and ensure that those familiar with the device are directly involved.
• Outsourcing: If you lack internal resources or want to ensure an unbiased perspective, outsourcing to a qualified third-party reviewer is the best approach. The key is to ensure that the external reviewer has no conflicts of interest and is highly qualified.

Example Reviewers: Qualified vs. Not Qualified

Qualified Reviewer:
Dr. Sarah Thompson

• Education: PhD in Biomedical Engineering
• Experience: 10 years in medical device research
• Regulatory Knowledge: In-depth understanding of EU MDR
• Medical Writing: Extensive experience with regulatory submissions

Dr. Thompson is a qualified reviewer because of her robust educational background, extensive field experience, and specific knowledge of the EU MDR requirements.

Not Qualified Reviewer:
John Doe

• Education: Bachelor’s in Marketing
• Experience: 5 years in medical device sales
• Regulatory Knowledge: Basic understanding

While John has experience in the medical device industry, his lack of scientific, clinical, or regulatory expertise disqualifies him from conducting a thorough clinical evaluation.

Addressing Potential Conflicts of Interest

In some cases, a reviewer may have a potential conflict of interest, even if they are otherwise qualified. For example:

Conflict of Interest Example:
Jane Smith

• Education: Master’s in Regulatory Affairs
• Experience: 8 years in regulatory affairs for the same company’s medical devices

Although Jane is highly qualified, her role within the company manufacturing the device poses a potential bias. In such cases, it may be prudent to hire an external reviewer to ensure objectivity.

Best Practices for Managing Reviewers

To maintain compliance and ensure unbiased evaluations, here are some best practices:

• Maintain Transparency: Always disclose potential conflicts of interest by attaching a DOI statement to the review.
• Choose External Reviewers Wisely: Ensure that external reviewers have no vested interests in the device’s commercial success.
• Balance Internal Expertise with External Objectivity: A combination of internal knowledge and external oversight ensures comprehensive, impartial evaluations.

Conclusion: Ensuring Compliance with Qualified Reviewers

The EU MDR places a strong emphasis on ensuring that clinical evaluations and literature reviews are conducted by qualified reviewers. Whether you handle reviews internally or outsource them, it’s critical that the reviewers meet the qualifications outlined by MEDDEV and the EU MDR. By adhering to these guidelines, you can ensure that your evaluations are thorough, impartial, and compliant with regulatory standards.