QA Regulatory forum: Classification and Risk assessment according to MDR Date : T h e r e s e. A l b i n s s o m e d q t e c h.

Transcription

1 QA Regulatory forum: Classification and Risk assessment according to MDR Date : THERESE ALBINSSON T h e r e s e. A l b i n s s o m e d q t e c h. s e

2 MedQtech AB MedQtech AB is a consultant business within the medical device industry. We support and help our customers in the fields of quality and regulatory compliance. My background: Over 15 years within Medical Device Industry Support in ISO Certification, Support in Medical Device CE-marketing process Regulatory strategy support Compliance MDD/MDR IVDD/IVDR Facilitation of Risk Management, ISO 14971, Internal audits, supplier audits

3 IVDR In vitro Diagnostics Classification and risk based rules

4 Risk based rules IVD IVDR Annex II list A Class D R I S K Annex II list B Class C Class B R I S K Other Class A

5 Ref. MDR & IVDR EU Conference 2017

6 Article 47 Classification of devices Devices shall be divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks. Class A, Low individual risk and low risk to public health Class B, Moderate individual risk and/or low risk to public health Class A Self-certify ( if sterile IVDs need assessment by NB) Ref. IVDR, Article 48 Class C, High individual risk and/or medium risk for public health Class D, High individual risk and high risk for public health Class C & D Require Quality Management System surveillance of Notified body Ref. IVDR, Article 48, Annex IX Class B, C & D EU technical documentation assessment certificate by Notified Body Ref. IVDR, Article 48, Annex IX

7 IVDR - ANNEX VIII Classification Rules Rule 1 Rule 2 Rule 3 Rule 4 Rule 5 Rule 6 Rule 7 Blood screening High risk diseases Blood grouping High risk dissades Infection diseases Cancer testing Companion diagnostics Geneteic testing. Self testing High risk near patient test Blood gases Blood glucose General laboratory use Non-critical accessories Buffer solutions Instruments None of the other rulse Unassayed conrols High risk blood groups Self test for non-critical conditions Class D Class C Class D Class C Class C Class B Class A Class B Class B

8 Class A May self-certify, but Class A sterile IVDs require an assessment by the NB of the sterile aspects according to Annex IX (or Annex XI). Class B Require quality systems (Annex IX except Chapter II) NBs sampling at least one technical file per generic device group as part of on-site audits unless these devices are self-testing or near-patient testing, in which case the technical documentation of all devices need to be assessed. Class C Require either a full quality management system combined with a review of the technical documentation of at least one device per generic device group (Annex IX except Chapter II), or an EC type-examination (Annex X) together with production quality assurance or EC verification (Annex XI). Class D Requires the same procedure as Class C, plus batch verification and reference laboratory involvement (Annex IX). (Alternatively Annex X and Annex XI certification is possible.) Ref. IVDR, article 48,

9 MDR Medical Device Regulations Classification and risk based rules

10 Article 51 - Classification of Device Devices shall be divided into Classes I (Is, Im, Ir), IIa, IIb and III taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII. Class IIa Class IIb Class III Class Is, Im, Ir Partly Notified body Registered to competent authority Class I, Self-certify, register to competent authority Require Notified Body Review of technical documentation Audit of Quality Management System

11 ANNEX VIII Classification Rules MDR -> 22 rules Rules 1-4: Non-invasive devices Rules 5-8: Invasie devices Rules 9-13 : Active Devices Ruleas : Special rules MDD -> 18 rules Rules 1-4: Non-invasive devices Rules 5-8: Invasie devices Rules 9-12 : Active Devices Ruleas : Special rules 5 new rules, some changes in existing rules and new class Ir, one rules in MDD has been dissmissed (rule 18)

12 MDR - ANNEX VIII Classification Rules Rule 3 Rule 4 Rule 8 Rule 18 Rule 20 Rule 22 All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III. This rule applies also to the invasive devices that come into contact with injured mucous membrane. Rule 6 Reusable surgical instruments in Class I, But a new classification, Class Ir, applies Added exemption of implantable devices to be classified as class III Rule 11 New rule for classification of software. Class I, IIa, IIb, III State that nonviable tissue of human or animal cells will be considered Class III. Rule 19 New classifies nanomaterials depending on their potential for internal exposure. Class IIa, class IIb, Class III New Places devices intended for inhalation of medicinal substances in risk Classes IIa or IIb. Rule 21 New places devices composed of substances absorbed or dispersed in different classes based on their level of internal exposure. New places active therapeutic devices with an integrated diagnostic function, which provides data on patient management Class III

13 What to do??? Intended use Re-classify your product under the new IVDR/MDR Create a Classification document. Explain the rules/rationales and the class for your device Set your Regulatory Strategy based on the class of the product.