MDR Conformity Assessment Procedure

 Conformity assessment is a procedure which demonstrates that device in compliance with MDR.

Notified body (NB) is a conformity assessment body that performs third-party conformity assessment activities including calibration, testing, certification and inspection.

Every manufacturer needs to undertake an assessment of the conformity of that device.

Conformity assessment Annexes are listed below,

1.ANNEX IX CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION

v  CHAPTER I QUALITY MANAGEMENT SYSTEM(QMS)

v  CHAPTER II ASSESSMENT OF THE TECHNICAL DOCUMENTATION(TD)

v  CHAPTER III ADMINISTRATIVE PROVISIONS (Record Retention)

EU Quality management system certificate , EU technical documentation assessment certificate

2.ANNEX X CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION

Product based EU type-examination certificate

3.ANNEX XI CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION.

v  PART A PRODUCTION QUALITY ASSURANCE

EU Quality assurance certificate

v  PART B PRODUCT VERIFICATION

EU Product verification certificate

Note: There is no equivalent MDD Annex VI Product Quality Assurance conformity assessment route is available in MDR.

Manufacturer can select conformity assessment route based on device class. MDR CHAPTER V CLASSIFICATION AND CONFORMITY ASSESSMENT, Article 52 of SECTION 2 Conformity assessment explains the various conformity assessment routes as given below.

Class III:

1.     Option 1: Annex IX.

2.     Option 2: Annex X + Annex XI Part A Production quality assurance

3.     Option 2: Annex X + Annex XI Part B Product verification

The above options are applicable for Class III implants/Non-Implants, Devices incorporating a medicinal substance, Tissues or cells of human/animal origin or their derivatives, Rule 21 (Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body)

Special Cases:

·       Class III Implantable devices shall follow Clinical Evaluation Consultation Procedure (Article 54):CER scientific opinion from expert panel

·       Devices incorporating a medicinal substance: Medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC): Scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA (European Medicine Agency). If the device incorporates a human blood or plasma derivative or a substance that, if used separately, may be a medicinal product falling exclusively within the scope of the Annex to Regulation (EC) No 726/2004, the notified body shall seek the opinion of the EMA.

·       Tissues or cells of human origin or their derivatives: Scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2004/23/EC (‘human tissues and cells competent authority’) on the aspects relating to the donation, procurement and testing of tissues or cells of human origin or their derivatives.

·       Tissues or cells of animal origin or their derivatives: Notified body shall apply the relevant requirements laid down in the Regulation (EU) No 722/2012.

·       Rule 21 (Devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body): Scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA.

 

Class IIb:

·       Option 1: Chapters I QMS and III of Annex IX + Assessment of the technical documentation (TD). Class IIb-WET & Rule 12-TD assessment for at least one representative device per generic device group. Class IIb-Non-WET-TD assessment for every device.

1.     Option 2: Annex X + Annex XI Part A Production quality assurance

2.     Option 2: Annex X + Annex XI Part B Product verification

Special Cases:

·       Class IIb Rule 12 active devices shall follow Clinical Evaluation Consultation Procedure (Article 54):CER scientific opinion from expert panel

 

Class IIa:Implants /Non Implants:

1.     Option 1: Annexes II and III Technical documentation+ Chapters I QMS and III of Annex IX

2.     Option 2: Annexes II and III Technical documentation+ Annex XI Part A Production quality assurance

3.     Option 3: Annexes II and III Technical documentation+ Annex XI Part B Product verification

In general, all three options assessment of the technical documentation(TD) for at least one representative device for each category of devices.

Class Im/Is/Ir:

1.     Option 1: Annexes II and III Technical documentation+ Chapters I QMS and III of Annex IX *

2.     Option 2: Annexes II and III Technical documentation+ Annex XI Part A Production quality assurance*

* involvement of the notified body in those procedures shall be limited:

v  Class Is:  Aspects relating to establishing, securing and maintaining sterile conditions

v  Class Im: Aspects relating to the conformity of the devices with the metrological requirements

v  Class Ir: Aspects relating to the reuse of the device, cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.

Class I:

1.     Class I device shall have TD as per Annexes II and III.

2.     Self-certification without involving any Notified body

Custom made devices except Class III Implants:

Annex XIII +Section 8 of Annex IX: Document experience gained in the post-production phase, including from PMCF

Custom made Class III Implants:

1.     Option 1:  Annex XIII + Chapters I of Annex IX QMS

2.     Option 2: Annex XIII + Annex XI Part A Production quality assurance

Investigational devices shall be subject to the requirements set out in Articles 62 to 81.

Click below link to know more about IVDR Conformity Assessment Procedure :https://meddev-info.blogspot.com/2021/04/ivdr-conformity-assessment-procedure.html

Source:

1.REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

2.BSI whitepaper on Medical device clinical investigations – What’s new under the MDR?