MDR conformity assessment procedures

MDR Application Procedure

TÜV SÜD has developed an online service registration form to allow us to systematically process your request. If you would like to request MDR services from TÜV SÜD, please use this form to register your interest.

Based on the product classification, the manufacturer must apply for an applicable conformity assessment procedure.

Step-by-step information for each of the conformity assessment procedures (using the relevant Annex) is highlighted below. The graphics also provide an overview of the procedures for different device classes and types as well as relevant surveillance activities. Specific device types require additional assessments, which are listed in the tables below.

English and/or German are the only acceptable languages for the submission of documentation and any related correspondence.

The certification costs are based on hourly rates and take into account factors such as the size of company, sites, number and complexity of devices, etc.

The standard fees for the conformity assessment activities delivered by TÜV SÜD Product Service GmbH are as follows:

*Depending on the location of the manufacturer and possibility to include local experts or auditors in the conformity assessment procedure, prices may vary, and fees may be invoiced in local currency.

TÜV SÜD Product Service GmbH takes into account the interests of SMEs by basing its entire fee structure mainly on effort-related criteria rather than fixed steps, thus enabling SMEs in particular for a precise and individual cost calculation based on the effort involved in each individual case.

conformity assessment procedures under MDR

TÜV SÜD Product Service GmbH provides conformity assessment services according to MDR Annex IX, Annex X and Annex XI Part A or Part B as described below, and according to the notification details officially published in the EU NANDO Information System. Manufacturers can select an appropriate conformity assessment procedure depending on the risk class of the device. Depending on the applicable conformity assessment procedures, the MDR certification can result in either one or more combined types of EU Certificates (five different types available). These certificates can be valid for no longer than five years. On renewal application by the manufacturer, the validity of the certificate may be renewed for further maximum year periods, based on an assessment according to Annex VII, 4.11 on Re-certification.

General overview on certification process

The certification process under MDR Annex VII includes various phases of a five-year certification cycle: Initial certification (Pre-application activities to Certification), Changes and modifications, Surveillance activities and post certification monitoring, and Renewal. After renewal, another new five-year certification cycle starts again with Changes and modifications, and Surveillance activities and post certification monitoring until next renewal. All conformity assessment procedures (MDR Annex IX, X, XI Part A or Part B) under MDR follows the same steps. However, the content of application and conformity activities vary depending on the conformity assessment routes which are determined by the class of device and the specific characteristics of the device concerned.

Our Service Description provides a detailed overview of the individual conformity assessment procedure according MDR Annex IX, X, XI Part A or XI Part B.

Download the MDR Service Description (NB 0123)

specific procedures within the MDR

Audits on clinical aspects

Auditing clinical processes is an integral part of our QMS audits for all medical device manufacturers. Clinical processes shall be audited as part of every QMS audit and is a part of the conformity assessment activities for medical device manufacturers. Under MDR, clinical processes such as clinical evaluation, pre-clinical evaluation and clinical investigations where applicable are covered during QMS audits. Audits on clinical aspects are performed by an authorized and qualified auditor.

Periodic Safety Update Report (PSUR) – Article 86

Summary of Safety and Clinical Performance (SSCP) – Article 32