What Are the Responsibilities of a Site Auditor, a Product Reviewer and a Clinical Expert?
Key Participants in the Conformity Assessment
Conformity assessment for medical devices is fundamentally a manufacturer’s responsibility, however relevant legislation may require the involvement of a third party, known as notified body (conformity assessment body).
The key participants in the conformity assessment are: the legislator, the manufacturer, and, if mandated by law, the notified body or an internally accredited conformity assessment body.
Let’s look at the main tasks of each participant:
The legislator:
- determinates the legal requirements that the medical device must meet
- selects the conformity assessment modules/procedures from the “menu” established by an EU decision (Decision No 768/2008/EC).
The manufacturer:
- designs, manufactures, and tests (or arranges the design, manufacture or testing of) medical devices,
- complies the technical documentation for the device,
- takes all necessary measures to ensure the device’s conformity,
- if the device is positively evaluated, prepares the EU Declaration of Conformity and affixes the CE marking on the product (the CE marking indicates that the manufacturer has assessed the product and it complies with the relevant EU technical legal regulations, meaning the product is safe, suitable from health and environmental perspectives),
- and in the case of medical devices, it also fulfils the intended purpose defined by the manufacturer),
- if the notified body is involved, affixes the notified body’s identification number on the product.
The Conformity Assessment Body:
- carries out inspections and assessments if required by legislation,
- in the case of positive evaluation, issues the approval certificate or certification as prescribed by the relevant legislation.
How Does the Conformity Assessment Procedure Begin?
It is crucial for manufacturers of medical devices to categorize their devices into risk classes, considering the intended use and associated risks. The selected conformity assessment procedures must be based on these risk classes.
The European Union regulates medical devices and in vitro diagnostic medical devices through two separate regulations:
- MDR: Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices.
- IVDR: Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices.
After the manufacturer has classified their devices into the appropriate risk classes, they must, if necessary for specific devices, involve the notified body for the conformity assessment procedure and initiate the audit. This means that the manufacturer needs to contact a notified body and request a proposal for the conformity assessment of their devices.
What Are the Responsibilities of a Site Auditor?
The Site Auditor is an employee of the Notified Body and is responsible for conducting audits of the manufacturer’s quality management systems at the manufacturer’s headquarters and production sites.
This includes interviewing the manufacturer’s employees and inspecting various processes. The auditor can request various documents and will prepare a Non-Conformity Report on any deficiencies or irregularities observed during the audit. A detailed audit report is prepared for every on-site inspection. Audits are generally conducted by a group of auditors, with the lead auditor being the head of the audit team.
What Are the Responsibilities of a Product Reviewer?
The Product Reviewer is also an employee of the Notified Body and is responsible for reviewing medical devices and in vitro diagnostic medical devices.
They primarily assess whether the product’s technical documentation complies with regulatory and standard requirements.
This task does not necessarily require visiting the manufacturer’s site.
What Are the Responsibilities of a Clinical Expert?
The task of the clinical expert is to evaluate the product’s compliance from a clinical perspective, including the review of the manufacturer’s clinical evaluations and the examination of study data.
The MDR and IVDR require that notified bodies have personnel with permanent clinical expertise, preferably as employees of the organization. For this reason, this person is often referred to as an “Internal Clinician.” The Internal Clinician must be involved in the evaluation procedure aimed at determining whether external clinical experts need to be engaged in specific cases.
What Qualifications and Professional Experience Are Required for Someone to Become a Site Auditor, Product Reviewer or Clinical Expert?
| SPECIFIC ROLES | QUALIFICATIONS REQUIRED | PROFESSIONAL EXPERIENCE REQUIRED |
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SITE AUDITOR (SA) MDR/IVDR Annex VII. Section 3.2.6. |
University, technical college, or equivalent degree in relevant studies – for example medicine, pharmacy, engineering, or other relevant disciplines. |
4 years of professional experience in the field of health products or in activities related to health care – such as production, audit, research. (Out of 4 years of professional experience, 2 years must be spent in quality management.) |
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PRODUCT REVIEWER (PR) (MDR/IVDR Annex VII. Section 3.2.5.) |
University, technical college, or equivalent degree in relevant studies – for example medicine, pharmacy, engineering, or other relevant disciplines. |
4 years of professional experience in the field of health products or in activities related to health care – such as production, audit, research. (Out of 4 years of professional experience, 2 years must be spent in the design, construction, testing or use of medical devices). |
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CLINICAL EXPERT (MDR Annex VII. Section 3.2.4 and NBOG’s Best Practise Guide, 2017-2) |
The MDR/IVDR does not specify the necessary qualifications. However, the related Guide (NBOG 2017-2) generally expects a medical qualification. |
The MDR/IVDR does not specify the necessary professional experience either. However, the related Guide (NBOG 2017-2) generally expects a medical qualification. The MDR/IVDR does not specify the necessary professional experience either. According to the related Guide (NBOG 2017-2), the following is required:
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Important! Individual notified bodies may establish specific requirements, including stricter or additional requirements, that differ from the information in the table, and ultimately, the candidate must meet these requirements.
Written by: Attila Juhász (Professional Lead, SAASCO Kft.)