With the MDR there are significant changes, so also in the conformity assessment procedure. The procedures have been changed and are described in other annexes. The conformity assessment procedure is the proof that the essential safety and performance requirements are fulfilled. This proof must be provided by manufacturers of each medical device. In some cases, manufacturers can declare the conformity of their products themselves, but often this requires defined and complex procedures.

What is conformity assessment?

According to the MDR, conformity assessment is a procedure that determines whether the requirements of the MDR for the medical device have been met. Before manufacturers place a medical device on the market, this conformity assessment must be performed with a positive result. The MDR specifies the applicable conformity assessment procedures for this in Annex IX to XI. A conformity assessment must also be carried out when a manufacturer puts a product into service that has not yet been placed on the market. Only after successful conformity assessment, a manufacturer may affix the CE marking on his medical devices.

Which conformity assessment procedure is the right one for me?

There are different types of conformity assessment procedures:

Conformity assessment based on a quality management system and technical documentation assessment (Annex IX).

Conformity assessment based on type examination (Annex X)

Conformity assessment based on product conformity testing (Annex XI).

Which of these procedures has to be applied concretely depends on the respective medical device class.

For manufacturers of class III devices, the procedure according to Annex IX applies, which certifies the QM system. Excluded are custom-made products or test products. Alternatively, the procedure according to Annex X for type examination in combination with that from Annex XI for product conformity testing can be carried out.

Manufacturers of Class IIa and IIb devices, with the exception of custom-made and investigational devices, must perform the QM system procedure according to Annex IX, Chapters I and III and, in addition, a technical documentation assessment according to Chapter II. For implantable Class IIb devices, however, this technical documentation assessment must be performed for each device. However, a number of devices are exempt: Sutures, braces, dental fillings, dental braces, dental crowns, screws, wedges, dental or bone plates, wires, pins and connectors. Alternatively, manufacturers may perform the Annex X procedure (type examination) in combination with an Annex XI assessment (product conformity assessment). For Class IIa devices, technical documentation according to Annex II and III may alternatively be prepared in combination with the procedure according to Annex XI Section 10 or 18.

Manufacturers of Class I devices issue the EU Declaration of Conformity according to Article 19, MDR and thereby declare the conformity of their devices. However, the technical documentation according to Annexes II and III must be prepared beforehand. Devices in this class that are placed on the market in a sterile condition, have a measuring function, or are reusable surgical instruments, the manufacturer must use either the assessment procedure from Annex IX, Chapters I and III, or Annex XI, Part A.

For custom-made devices, the procedure in Annex XIII (“Procedure for custom-made devices”) shall be used and a declaration in accordance with Section 1 of this Annex shall be issued prior to placing on the market. Class III implantable custom devices must follow the procedure in Annex IX, Chapter I (Certification of QM System).

Occasionally, manufacturers may be exempted from going through the conformity assessment procedure upon request. However, this is only possible if it is verified in advance that the medical device in question will benefit public health and patient safety or health.

Involvement of a Notified Body

If the involvement of a Notified Body is required, the medical device manufacturer may submit an application for the procedure to a Notified Body of his choice. In the course of the procedure, the Notified Body can request all necessary information and data from the manufacturer, which are required to carry out the procedure. At the end of the procedure, the Notified Body issues a so-called certificate of conformity. This certificate is valid for a maximum of 5 years. An extension of the certificate is possible upon application of the manufacturer and an accompanying reassessment. The number and availability of Notified Bodies is currently problematic – and this will only change very slowly. In recent years, some notified bodies have already given up, while others have limited their scope. Therefore, there are considerable bottlenecks in the approval of new medical devices according to the MDR or the conversion of already approved products from the MDD to the MDR.

The flow of the procedure

(The counting method in this section refers to the list above)

Quality management system

The manufacturer establishes a quality management system in accordance with the requirements of the MDR. This is documented and implemented and the system must be effective throughout the life cycle of the products. For conformity assessment, the manufacturer must apply to the Notified Body for an assessment of the quality management system. Effective implementation of the QM system ensures that the requirements of the MDR are met. For the assessment of the QM system, the following aspects, among others, must be documented: Manufacturer’s quality objectives, organization of the company, procedures and techniques for monitoring, verification, validation and control of product design, quality assurance and control techniques for manufacturing, testing before, during and after manufacturing. Furthermore, the manufacturer must also provide the technical documentation.

In a next step, the Notified Body now performs an audit of the QM system to check whether it meets the given requirements. If the manufacturer applies other standards, conformity with these standards is also assessed. If the audit is passed, an EU Quality Management Certificate is issued by the Notified Body.

A surveillance assessment is carried out for class IIa, IIb and III products (also for Im, Is, Ir). The Notified Body now carries out audits and assessments on a regular basis (usually annually as well as unannounced at least once in 5 years) to ensure that the manufacturer continues to apply the previously approved QM system and additionally implements the post-market surveillance plan. For Class IIa and IIb devices, the surveillance assessment also includes an assessment of the technical documentation.

Type examination

A so-called type examination is an EU procedure in which a notified body determines that a product, including its technical documentation and the relevant processes during the product life cycle, complies with the requirements of the MDR.

For this procedure, too, the manufacturer must submit an application to a Notified Body. The assessment is then carried out by the notified body on the basis of tasks defined in advance. Among other things, the technical documentation must be checked for product conformity and whether the type has been created in accordance with the documentation. The clinical evaluation of the product and other important aspects are also subjected to the examination. At the end, the Notified Body issues a type examination report documenting all results. If the type meets the MDR requirements, an EU type examination certificate is issued. Changes to the type must be reported immediately to the Notified Body and approved by it.

Product conformity

This assessment procedure is intended to ensure that products that already have an EU type examination certificate comply with their type and the requirements of the MDR. This can be done in two ways: Either following the production quality assurance procedure or the product verification procedure.

In the first production quality assurance procedure, the manufacturer implements a QM system and ensures that it is followed in the manufacturing process. To demonstrate conformity with the underlying type, the manufacturer draws up a declaration of conformity for the product in question. The next step is to submit an application to the Notified Body for assessment of the QM system. If the QM system ensures that the products conform to the type described in the EU type examination certificate and that it meets the requirements of the MDR, the Notified Body issues an EU quality assurance certificate.

Product verification is to be understood as a procedure such that the manufacturer subjects each manufactured product to a test and confirms that the product conforms both to the type described in the EU type-examination certificate and to the requirements of the MDR. For this purpose, the manufacturer must take all necessary measures (including specification of the manufacturing processes, documentation). The notified body uses tests to check whether the conformity of all products is guaranteed. The Notified Body then affixes its identification number to each approved product, or has it affixed, and issues an EU product verification certificate on the tests and assessments carried out.

Do not despair

At first glance, the conformity assessment procedure with all its variants and forms may seem overwhelming. But once the risk class of the medical device has been determined, the possible options in the conformity assessment procedures are relatively clear.

To ensure a smooth process in this regard, you can enlist the support of a team of experts. We will gladly take over this task for you!

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.