Who needs a QMS under MDR/IVDR? Roles, responsibilities, and EU certificates explained

Who needs a QMS under MDR/IVDR? This guide by Dr. Kirsten Theiling, QMB at Metecon, clearly outlines roles, obligations, and EU certifications for manufacturers, distributors, and service providers.

Under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), manufacturers of medical devices and in vitro diagnostic medical devices are required to establish, implement, and continuously improve a quality management system (QMS). However, this obligation does not apply exclusively to traditional manufacturers; distributors, importers, system providers, and certain service providers may also fall within the scope of the QMS requirements.

At the same time, there is uncertainty regarding the role of Notified Bodies and which EU certificates are issued as part of the conformity assessment.

This first part of the series systematically outlines

• which economic operators require a QMS,
• what significance the QMS has in the conformity assessment procedure, and
• how the various EU quality management certificates can be classified.

EU economic operators: Who needs a Quality Management System?

The recitals of the MDR and IVDR already make it clear that manufacturers should have a QMS in place to ensure that mass-produced products meet regulatory requirements and that experience gained from use is systematically fed back into the production process (MDR Recital 32 / IVDR Recital 31).

This expectation is specified in Article 10 of the MDR and Article 10 of the IVDR. Manufacturers are required to establish, document, maintain, keep up to date, and continuously improve a QMS. For this purpose, manufacturers also include companies and individuals who

• reprocess products, for example through cleaning, disinfection, or sterilization (MDR Art. 2 No. 39 / IVDR Art. 2 No. 24) or
• develop new products and place them on the market under their own name or brand (MDR Art. 2 No. 30 / IVDR Art. 2 No. 23).

In addition, the MDR and IVDR also require a QMS for other economic operators, which must include processes specific to the activities carried out by these companies or by individuals. These include, among others:

• manufacturers of products without a medical purpose as defined in MDR Annex XVI (MDR Art. 1(2)),
• manufacturers of parts or components that significantly alter the performance, safety characteristics, or intended purpose of a product (MDR Art. 23 / IVDR Art. 20),
• distributors, importers, or other natural or legal persons who assume manufacturer obligations pursuant to Article 16(1) of the MDR/IVDR,
• suppliers of systems or procedure packs (MDR Art. 22),
• suppliers and service providers performing activities within the manufacturer’s area of responsibility (see MDR/IVDR Annex VII Section 4.5.2 a).

It is therefore crucial for companies to clearly define their own regulatory role, as the scope, depth, and structure of the QMS are derived from this.

The role of notified bodies in the Quality Management System

Compliance with MDR/IVDR requirements is enforced in EU member states by conformity assessment bodies that have been officially designated for this task by a designated national authority. The name "Notified Body" derives from this process. Notified Bodies are thus state-authorized organizations that, on behalf of the respective national authorities, conduct inspections and evaluations as part of the conformity assessments required by the regulations. In Germany, the "Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (Central Agency of the Federal States for Health Protection in the Field of Medicinal Products and Medical Devices)" (ZLG) is responsible for the designation and supervision of Notified Bodies.

With regard to the QMS required by the MDR/IVDR, the Notified Bodies are responsible for auditing and certifying the QMS. This includes conducting appropriate surveillance audits and unannounced audits (MDR/IVDR Annex VII Sections 4.5 and 4.10, as well as Annex IX and Annex XI). The assessment of the QMS takes place within the framework of the conformity assessments conducted in accordance with Annex IX or Annex XI.

Significance of the QMS in the conformity assessment procedure

Purpose of conformity assessment

Conformity assessments serve to demonstrate that medical devices and IVDs meet the quality and safety requirements set forth in the MDR and IVDR.

The relevant and highly detailed QMS requirements are set forth in Article 10 of the MDR/IVDR and in Annexes IX and XI.

Depending on the risk class of the products to be assessed, different conformity assessment procedures are possible. The selection of the procedure to be applied depends on the respective product risk class (Art. 52 MDR, Art. 48 IVDR).

Conformity assessment according to Annex IX: QMS as the central basis

MDR/IVDR Annex IX describes the conformity assessment based on a QMS and an evaluation of the technical documentation and contains a detailed list of all QMS documents that must be submitted to the Notified Bodies for evaluation. It is emphasized once again that the implementation of the QMS ensures compliance with the respective regulation. This makes it clear that the QMS constitutes the central basis of the conformity assessment.

Following a successful conformity assessment, an EU quality management system certificate and an EU technical documentation assessment certificate are issued.

Conformity assessment in accordance with Annex XI: Production quality assurance and product conformity assessment

IVDR Annex XI describes the procedure for conformity assessment based on production quality assurance. In addition to a type examination (Annex X), this procedure also includes the verification of the QMS approved for the manufacture of the products in question. Section 3 refers to Sections 2.1, 2.2, and 2.3 of Annex IX. Thus, the QMS assessment does not differ fundamentally from the procedure described in Annex IX. If the QMS assessment shows that the products conform to the type described in the EU type-examination certificate and meet the requirements of the IVDR, the Notified Body issues an EU production quality assurance certificate.

MDR Annex XI describes the procedure for a conformity assessment based on a product conformity verification. If manufacturers opt to apply Part A of the Annex, a type examination (Annex X) is conducted in combination with a review of the QMS approved for the manufacture of the relevant products, as is the case with IVDs. Upon successful assessment, the Notified Body issues an EU quality assurance certificate in addition to the EU type examination certificate.

Certificates issued in accordance with Annexes IX, X, and XI are valid for a maximum of five years (MDR Art. 56, IVDR Art. 51).

Article 16(4): EU certificate for repackaging and relabeling

Following the introduction of the MDR/IVDR, there is another group of economic operators that had to adapt their QMS with regard to the establishment and monitoring of their QMS:

If distributors or importers translate the information to be provided by the manufacturer or modify the outer packaging in such a way that repackaging is required, they assume part of the manufacturer’s responsibilities through these activities and go beyond their original regulatory role.

In accordance with MDR/IVDR Article 16(4), they must, in such cases, commission a Notified Body to assess these activities. If the QMS for these activities complies with the requirements of the MDR/IVDR, the distributors or importers receive an EU certificate in accordance with Article 16(4) of the applicable regulation.

Preview of part 2

The first part of this series of articles shows that QMS requirements and EU certificates depend heavily on the respective role within the regulatory system. In addition, the question often arises as to the significance of an EN ISO 13485 certification, even though this is not explicitly required by the MDR and IVDR.

Part 2 of the series therefore examines the role of EN ISO 13485 in conjunction with Notified Bodies, regulatory oversight, and supply chain audits, and clarifies when certification is required or strategically advisable.

How Metecon supports

Metecon assists manufacturers and other economic operators in defining their regulatory role, establishing and further developing QMS structures, conducting internal audits, and preparing for conformity assessments and audits.

Would you like to systematically organize your QMS requirements?
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