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MDR conformity assessment procedures

MDR Application Procedure

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

The application forms requesting detailed information can be accessed here.

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 Germany are as follows:

Audit and QM System Assessment Services

Hourly Rate 

Audit

290€ 

Assessment of Change Notifications and Extensions for Quality Systems, MDR, IVDR

290€

Clinical Audit

290€ 

Technical Documentation Assessment Service

 

Technical Documentation Assessment Offsite

390€

Clinical Assessment

390€

 Technical Documentation Assessment Onsite for Class I* and Class II non-implantable

490€ 

conformity assessment procedures under MDR

Conformity assessment procedures under MDR

*Class III implantable devices, class III with incorporated medicinal product, class III utilising tissues or cells of human or animal origin, class IIb active devices intended to administer and/or remove a medicinal product

+Refer to the Nando website for the applicable products and procedures/annexes (update link once designation EU 2017/745 is available)

Annex IX

CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON THE ASSESSMENT OF TECHNICAL DOCUMENTATION

Chapter I: Quality Management System (QMS)

1. Application Management

  • Customer enquiry with application form
  • Non-binding quotation
  • Purchase order
  • Purchase order confirmation
2. Auditing (Full QMS)
  • Development of an audit programme
  • Customer submits company profile information
  • Documentation review (company profile information, QM documentation etc.)
  • Development of an audit plan
  • On-Site audit
  • Audit report

3. Technical Documentation (for classes IIa, IIb)
(Assessment of the technical documentation is performed before or during routine audits)

  • Customer submits technical documentation
  • Customer receives deficiency report (if applicable)
  • Customer addresses deficiencies
  • Final report released
4. Certification
  • QMS certificate(s) issued

Chapter II: Assessment of Technical Documentation (additional for classes III, IIb impl.)

1. Application Management
  • Customer enquiry with application form
  • Non-binding quotation
  • Purchase order
  • Purchase order confirmation

2. Technical Documentation Assessment

  • Customer submits technical documentation
  • Customer receives deficiency report (if applicable)
  • Customer addresses deficiencies
  • Final report released

3. Certification

  • Product certificate(s) issued

Annex X 

CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
 
1. Application Management
  • Customer enquiry with application form
  • Non-binding quotation
  • Purchase order
  • Purchase order confirmation

2. Assessment of Technical Documentation

  • Customer submits technical documentation
  • Customer receives deficiency report (if applicable)
  • Customer addresses deficiencies
  • Partial report

3. Testing

  • Generate test plan
  • Testing according to test plan
  • Partial technical report(s)

4. Certification

  • Final technical report
  • Type-examination certificate issued

5. Additionally required: conformity assessment according to Annex XI-A XI-B

annex XI

CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION

1. Annex XI (Conformity assessment based on product conformity verification)

  • Annex XI-A (solely for classes IIa, Is, Im, Irsi) 
  • Annex XI-B (solely for class IIa)
  • Annex XI-A (sections 6 and 7) in addition to Annex XI-B (for class IIa sterile)

2. Annex XI in addition to Annex X (Conformity assessment based on product conformity verification and type-examination)

  • Annex XI-A - in addition to Annex X (for classes III, IIb, IIb impl.) 
  • Annex XI-B - in addition to Annex X (for classes III, IIb, IIb impl.)

Part A Production Quality Assurance

1. Application Management

  • Customer enquiry with application form
  • Non-binding quotation
  • Purchase order
  • Purchase order confirmation

2. Auditing (Production QMS)

  • Generate audit programme
  • Customer submits company profile information
  • Documentation review (company profile information, QM documentation etc.)
  • Development of an audit plan
  • On-site audit
  • Audit report release

3. Technical Documentation (not applicable in cases where Annex XI is in addition to Annex X as this has already been assessed)

Please note: Assessment of the technical documentation is performed before or during the routine audits

  • Customer submits technical documentation
  • Customer receives deficiency report (if applicable)
  • Customer addresses deficiencies
  • Final report released

4. Certification

  • Production Quality Assurance certificate(s) issued

Part B Product Verification

5. Application Management

  • Customer enquiry with application form
  • Non-binding quotation
  • Purchase order
  • Purchase order confirmation 

6. Technical Documentation (class IIa only, others require Annex X)

  • Customer submits technical documentation
  • Customer receives deficiency report (if applicable)
  • Customer addresses deficiencies
  • Partial report release
7. Testing of each individual Device
  • Generate test plan
  • Testing according to test plan
  • Partial technical report(s)

8. Certification

  • Final technical report
  • Product verification certificate(s) issued

specific procedures within the MDR

 MDR procedures for specific device types

 

Periodic Safety Update Report (PSUR) – Article 86

 MDR periodic safety report update (PSUR) - Article 86

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

Summary of safety and clinical performance (SSCP) - Article 32 
 
 

 

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