MDR conformity assessment procedures

MDR Application Procedure

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

贰您 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.

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

批先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.

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 for the applicable products and procedures/annexes.

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. Technical Documentation
欧募 (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

• 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

• QMS certificate(s) issued

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

• 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 

• 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)

弄夯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

1. Application Management

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

2. Technical Documentation

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

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

4. Certification

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

specific procedures within the MDR

CLINICAL AUDITS

墓责Auditing clinical processes is an integral part of our QMS audits for all medical device manufacturers. The MDR has put even more emphasis on requirements related to clinical aspects. Consequently, focussed clinical audits are conducted as a risk-based surveillance activity within the regular conformity assessment process under the MDR. These clinical audits are targeted at medical device manufacturers of high-risk products (implants, class III and class IIb rule 12 devices) at least once every 3 years. In addition, and irrespective of the medical device class, clinical audits can be triggered in response to information that raises concern about the compliance and/or effectiveness of clinical processes of a medical device manufacturer. Clinical audits are performed by auditors, with specialised qualification and training in the field of clinical affairs.

Periodic Safety Update Report (PSUR) – Article 86

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