THERESE ALBINSSON [email protected] QA Regulatory forum: Classification and Risk assessment according to MDR Date : 05.04.2018
Jun 02, 2021
THERESE ALBINSSON
T h e r e s e . A l b i n s s o n @ m e d q t e c h . s e
QA Regulatory forum: Classification and Risk assessment according to MDRDate : 05.04.2018
MedQtech ABMedQtech AB is a consultant business within the medical device industry. We support and help ourcustomers in the fields of quality and regulatory compliance.
My background:
▪ Over 15 years within Medical Device Industry
▪ Support in ISO 13485 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
IVDR – In vitro Diagnostics
Classification and risk based rules
Risk based rulesRISK
Annex II list A
Annex II list B
Other
Class B
Class C
Class D
Class A
RISK
IVD IVDR
Ref. MDR & IVDR EU Conference 2017
Article 47 – Classification of devices
Class A,
Low individual risk and low risk to public health
Class B,
Moderate individual risk and/or low risk to public health
Class C,
High individual risk and/or medium risk for public health
Class D,
High individual risk and high risk for public health
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 C & D Require Quality Management System surveillance of Notified bodyRef. IVDR, Article 48, Annex IX
Class B, C & D EU technical documentation assessment certificate by Notified BodyRef. IVDR , Article 48 , Annex IXClass A
Self-certify ( if sterile IVDs need assessment by NB)Ref. IVDR, Article 48
Rule 1 Rule 2 Rule 3 Rule 4 Rule 5 Rule 6 Rule 7
Blood screening
High risk diseases
Class D
Blood grouping
High risk dissades
Class C Class D
High risk blood groups
Infection diseases
Cancer testingCompanion diagnostics
Geneteic testing
….
Class C Class C Class A Class B Class B
Self testing
High risk near patient test
Blood gasesBlood glucose
…
Class B
Self test for non-critical conditions
General laboratory use
Non-critical accessories
Buffer solutions
Instruments
None of the other rulse
Unassayed conrols
IVDR - ANNEX VIII – Classification Rules
Class D
Class C
Class A
Class B
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).
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.
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).
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,
MDR – Medical Device Regulations
Classification and risk based rules
Class I,
Self-certify, register to competent authority
Class Is, Im, Ir
Partly Notified body
Registered to competent authority
Class IIaClass IIb
Class III
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.
Require Notified Body Review of technical documentation Audit of Quality Management System
Article 51 - Classification of Device
ANNEX VIII – Classification Rules
MDR -> 22 rules
Rules 1-4: Non-invasive devices
Rules 5-8: Invasie devices
Rules 9-13 : Active Devices
Ruleas 14-22 : Special rules
MDD -> 18 rules
Rules 1-4: Non-invasive devices
Rules 5-8: Invasie devices
Rules 9-12 : Active Devices
Ruleas 12-18 : Special rules
5 new rules, some changes in existing rules and new class Ir, one rules in MDD has been dissmissed (rule 18)
Rule 3 Rule 4
Rule 6
Rule 8
Rule 11
Rule 18
Rule 19
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.
Reusable surgical instruments in
Class I, But a new
classification, Class Ir, applies
Added exemption of implantable
devices to be classified as
class III
New rule for classification of
software.
Class I, IIa, IIb, III
State that non-viable tissue of
human or animal cells will be
considered Class III.
Newclassifies nano-
materials depending on
their potential for internal exposure. Class IIa, class IIb,
Class III
MDR - ANNEX VIII – Classification RulesRule 20
NewPlaces devices intended for inhalation of
medicinal substances in
risk Classes IIa or IIb.
Rule 21
Newplaces devices composed of
substances absorbed or dispersed in
different classes based on their level
of internal exposure.
Rule 22
Newplaces active
therapeutic devices with an integrated
diagnostic function, which provides data
on patient management
Class III
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.