Request versus Application for Certification

In a lot of conformity assessment procedures, manufacturers have to involve notified bodies and, therefore, have to submit an application for certification to them.

Manufacturers should prepare these applications for certification very carefully, because notified bodies also have to file a refusal in EUDAMED. Such a refusal acts as a signal for other notified bodies.

  Overview of content

1. Application procedure »

2. Documents required »

3. Application review »

1. Application procedure

Notified bodies must publish “a publicly available description of the application procedure by which manufacturers can obtain certification from it”. Notified bodies fulfill this obligation by publishing this description on their websites.

Manufacturers should then submit a request, for example, to find out the types of contract available. In contrast to the applications, these requests can be sent to several notified bodies.

Fig. 1: The procedure for an application for certification from the perspective of a manufacturer and a notified body (click to enlarge)

An official application has been submitted once the manufacturer signs (and therefore) accepts the contracts or offer from the notified body and returns it/them to the notified body.

According to Article 53 of the MDR, a manufacturer may lodge an application with only one(!) notified body at a time.

If the application is not accompanied by all necessary information, the notified body must refuse the application.

The notified body must also document its refusal of an application or the withdrawal of an application by the manufacturer in EUDAMED (where it is accessible to another notified bodies).

 

N.B!

Please note: Manufacturers should ensure that they enclose all the required documentation in full.

Both a refusal of an application by the notified body and a withdrawal of an application must be recorded in EUDAMED.

This could cause other notified bodies to refuse a new application, because the EU Commission is likely to look at these cases extremely closely

2. Documents that must accompany the application for certification

Overview

The question of which documents a manufacturer has to submit to the notified body when submitting an application for certification to a notified body is governed by one the annexes to MDR (e.g., Annex IX, paragraph 2.1) as well as the notified body. In fact Article 53(4) entitles them to “require any information or data from the manufacturer, which is necessary in order to properly conduct the chosen conformity assessment procedure.”

Figure 2 shows how extensive the documents that have to be submitted are:

  • Formal: The application itself, confirmations
  • Information about the manufacturer
  • Information about the devices
  • On request, the technical documentation or extracts of it

Quality management system, in particular the procedural instructions

Fig. 2: Manufacturers must submit comprehensive documentation with the application. This includes, in particular, the complete quality management system. (click to enlarge or download PDF)

Download PDF with mind map

Documents that do not necessarily have to be enclosed

The volume of information that has to be submitted often leads manufacturers to ask which documents do not have to be submitted. The following documents do not normally have to be sent with the application:

  • Records from the QM system, e.g., from internal audits or management reviews
  • Technical documentation: Manufacturers need only provide access to these documents. Nevertheless, we recommend including enough information about the devices so that the notified body can review the classification of the device.
  • Documents that may not yet be available because the conformity assessment hasn’t been completed yet and therefore the device cannot be placed on the market.

3. Review of the application for certification

The notified body then reviews the application to determine whether

  1. The application has been submitted in writing and formally
  2. And that the contract with the manufacturer has been as well
  3. All the documents required by the MDR, e.g., according to Annex IX, paragraph 2.1, have been attached
  4. The products are actually medical devices
  5. The medical devices have been correctly classified
  6. The manufacturer has chosen the right conformity assessment procedure
  7. It is itself competent to assess the conformity of the device and the conformity assessment procedure
  8. It itself has sufficient and sufficiently qualified resources.

These requirements are contained, for example, in Annex VII (“Requirements to be met by notified bodies”) in section 4. (“Process requirements”) and sub-section 4.3 (“Application review and contract”).

This application review should not be confused with the conformity assessment. However, a successfully reviewed application is an indispensable requirement for the conformity assessment and the associated audit and certificate

Conclusion

Manufacturers should not confuse applications and requests. As soon as they make the formal application, they're playing for real because notified bodies have to file their decisions in EUDAMED and so disclose them to other notified bodies. Therefore, manufacturers should file their applications very carefully and in full.

The German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) will scrutinize the application review in particular when inspecting a notified body. Nevertheless, we hope that notified bodies will act with a sense of proportion and request a missing or suboptimal document rather than immediately refuse an application.

Ideally, the notified bodies would make the checklists they use when reviewing applications for certification or for conformity assessments available to manufacturers. That would make it easier for manufacturers to jump the first hurdle with the notified body.