LNE/G-MED North America, Inc MDR Common changes, Timeline for - - PowerPoint PPT Presentation

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LNE/G-MED North America, Inc

MDR Common changes, Timeline for changes and the Impact on manufacturers.

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Speaker

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Agenda

• Introduction
• Origin of MDR
• Goal of MDR
• Summary of the main changes in the regulation
• Expected timeline for the changes to be

implemented

• How manufacturers can prepare
• Tips and conclusion

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Introduction

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• The MDR proposal started back in 2008 when the EU

commission triggered a consultation on the community’s existing requirements covering medical devices.

Origin of MDR

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Origin of MDR

The plan was 1st released by the commission in 2012 to modify the EU’s medical device regulatory framework along with a proposed regulation replacing:

• EU’s current medical device directive

(93/42/EEC)

• EU’s directive on active implantable medical

device (90/385/EEC)

• In Vitro Diagnostic directive (98/79/EC)

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Goal of MDR

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Goal of MDR

• This regulation aims to ensure the smooth functioning of the

internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small-and medium-sized enterprises that are active in this sector.

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• This regulation sets high standards of quality and safety for

medical devices in order to meet common safety concerns as regards such products.

Goal of MDR

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• f notified

bodies Conformity assessment procedures Clinical investigations & evaluation Vigilance and market surveillance

Goal of MDR

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Summary of main changes in the regulation

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• 1. Wider, clearer scope of the products covered:

The scope of the products will become broader to include:

• Medical devices which may not have the intended

medical purpose

• Devices for the purpose of prognosis of the a disease or

any other health condition

Summary of main changes in the regulation

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• 2. Changes in the clinical investigation for medical devices as part of

the requirements of the clinical evaluation:

• The MDR will put in place a European regimen for clinical

investigations that will replace the diversity of member state regulation in the EU.

• It will introduce many new concepts relating to clinical evaluation and

clinical investigation, as well as a mandatory PMCF and Periodic Safety Update Reports (PSURs).

Summary of main changes in the regulation

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class IIa class IIb class III

PSUR

Devices

• 2. Changes in the clinical investigation for medical devices as

part of the requirements of the clinical evaluation:

Summary of main changes in the regulation

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PSUR shall set out:

• The conclusions of the benefit-risk determination
• The main findings of the PMCF
• The volume of sales of the device and an estimate evaluation
• f the size and other characteristics of the population using

the device and, where practicable, the usage frequency of the device.

• 2. Changes in the clinical investigation for medical devices as

part of the requirements of the clinical evaluation:

Summary of main changes in the regulation

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Class IIb and III Class IIa

1

2

PSUR Update Years

Summary of main changes in the regulation

• 2. Changes in the clinical investigation for medical devices as

part of the requirements of the clinical evaluation:

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The notified body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSURs and the evaluation by the notified body shall be made available to competent authorities through that electronic system up on request.

• 2. Changes in the clinical investigation for medical devices as

part of the requirements of the clinical evaluation:

Summary of main changes in the regulation

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Please note that with the new rules; the manufacturers will need to perform: Gap analysis to identify gaps in clinical evidence under new rules for devices currently on the market and perform the required update since the compliance to current MEDDEV’s without an update to the clinical strategy and performing the gap analysis will not be sufficient.

Summary of main changes in the regulation

• 2. Changes in the clinical investigation for medical devices as

part of the requirements of the clinical evaluation:

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This will require:

• A thorough review of the manufacturer’s clinical strategy

and PMCF plans.

• Manufacturers to conduct clinical performance along with

providing evidence of safety and performance in accordance to the risk associated with the device

• Collect post –market clinical data.
• 2. Changes in the clinical investigation for medical devices as

part of the requirements of the clinical evaluation:

Summary of main changes in the regulation

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• 3. Unique device identification (UDI):

In order to improve the ability of the authorities and manufacturer to trace the specific devices through the supply chain and to smooth the recall process of medical devices that have been found to present a safety risk, the MDR mandates the use of unique device identification (UDI) mechanisms.

Summary of main changes in the regulation

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The UDI system should apply to all devices placed on the market except custom-made devices.

• 3. Unique device identification (UDI):

Summary of main changes in the regulation

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• 4. Creation of European Database on Medical Devices (Eudamed).

Summary of main changes in the regulation

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The purpose is to integrate different electronic systems to collate and process information regarding devices on the market and the relevant economic operators, certain aspects of conformity assessment, notified bodies, certificates, clinical investigations, vigilance and market surveillance.

• 4. Creation of European Database on Medical Devices (Eudamed).

Summary of main changes in the regulation

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The European database on medical devices (Eudamed) will:

• Enhance overall transparency,
• Provide better access to information for the public and

healthcare professionals,

• Avoid multiple reporting requirements.
• 4. Creation of European Database on Medical Devices (Eudamed).

Summary of main changes in the regulation

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• 5. Classification and conformity assessment:

There will be an impact on the classification for certain medical devices; reclassification of the medical devices to a higher risk class is possible.

Summary of main changes in the regulation

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The review of the lower risk devices will be highly enforced

• n clinical evaluation so the manufacturer should:
• Revisit the content of the current technical file as there

will be an impact on the existing quality systems and to take into account the changes in the conformity assessment rules,

• The regulation will feature new essential safety and

performance requirements.

• 5. Classification and conformity assessment:

Summary of main changes in the regulation

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• 6. Impact on the post market clinical follow up (PMCF):
• This process will mainly drive the clinical performance

evaluation, and must be based on real-life data. Its results must be taken into account for clinical evaluation and risk management.

• The manufacturer will need to review their current PMS

and vigilance procedures with evaluation linked to the review of the risk management and clinical evaluation.

Summary of main changes in the regulation

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The PMCF plan shall include at least:

• The general methods and procedures of the PMCF,
• The specific methods and procedures of PMCF,
• A rationale for the appropriateness of the methods and procedures

referred to in the points above,

• Specific objectives to be addressed by the PMCF,
• An evaluation of the clinical data relating to equivalent or similar

devices,

• A detailed and adequately justified time schedule for PMCF activities.
• 6. Impact on the post market clinical follow up (PMCF):

Summary of main changes in the regulation

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• The field of intervention will be increased following the

MDR; unannounced audits, along with product sample checks and product testing will strengthen the EU’s enforcement regime.

• Annual safety and performance reporting by device

manufacturers will also be required in many cases.

• 6. Impact on the post market clinical follow up (PMCF):

Summary of main changes in the regulation

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• 7. Specifications:
• Common specifications' (CS) means a set of technical and/or clinical

requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or

• system. Where:
• No harmonized standards exist,
• Relevant harmonized standards are not sufficient,
• There is a need to address public health concerns, by means of

implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements.

Summary of main changes in the regulation

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• 8. Person responsible for regulatory compliance:
• At least one person must be assigned within the
• rganization that should be responsible for all aspects of

compliance with the requirements of the MDR.

• The qualifications of this individual must be documented

and be available up on request.

Summary of main changes in the regulation

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Expected timeline for the changes to be implemented

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• The timeline for the changes is dependent upon the

successful conclusion of consultations between the EU commission, the EU Parliament and the EU council.

• The final publication for both EU medical device and in Vitro

Diagnostic regulations expected to be released no later than May 2017.

Expected timeline for the changes to be implemented

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How manufacturers can prepare

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How manufacturers can prepare:

• It’s recommended that the manufacturer should be proactive

by starting to consult their notified body in order to build a plan and evaluate the impact on the manufacturer with gap analysis to identify all changes per the regulation.

• Early preparation and action from the manufacturer is the

best way to assure smooth transition to the new requirements.

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• The manufacturer should stay up to date with the MDR

changes and with the whole process.

• It is expected from the manufacturer to be proactive by

building a plan and evaluating the impact on its organization with gap analysis to identify all changes per the regulation.

How manufacturers can prepare:

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Tips and conclusion

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1- Manufacturers will need carefully to review the new rules for each device group and define a strategy to comply with the new requirements, they need to start developing a transition plan for their devices currently on the market to be re-certified under the new rules, 2- Technical files will need to be revisited, additional clinical evidence must be generated and declarations

• f conformity must be amended (Annex I)

Tips and conclusion

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Tips and conclusion

3- The manufactures must be aware of some topics per the transition period:

• Transitional period duration,
• When CE certificates issued under the current Directives

will expire.

?

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4- Manufacturers must check if their device(s) fall(s) under the new Medical Devices Regulation, 5- Manufacturers must check if a re-classification is needed

Tips and conclusion

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6- Manufacturers must follow the new Conformity Route Assessment options and requirements, including Annex I, 7- Manufacturing should start discussing with both the Competent Authority and the Notified Body about the changes,

Tips and conclusion

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LNE/G-MED North America, Inc

Thank you!

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LNE/G-MED North America, Inc The IVD Regulation Changes and Timelines

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Speaker

Sheena Bond

Lead Auditor ISO 13485, ISO 9001, CMDR, MDD, IVDD IVD specialist at GMED NA Technical documentation and design dossier assessor. Annex II, List A and List B products

LNE / G-MED North America, Inc.

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Agenda

• Where are we now and how did

we get here?

• Major Changes to consider.
• Next step for the manufacturer

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The Formal process

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Directives vs. Regulations

• Directives

A "directive" is a legislative act that sets out a goal that all EU countries must achieve through national

• transpositions. However, it is up to the individual

countries to decide how.

• Regulations

A "regulation" is a binding legislative act. It must be applied in its entirety across the EU.

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Major Changes from the Directive

• IVD – Definition & Scope
• UDI
• IVD Classification System
• Provisions on conformity assessment
• Clinical Data
• Vigilance and Market Surveillance

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IVD - Definition

• 'in vitro diagnostic medical device’ means any medical device which is a reagent,

reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: – concerning a physiological or pathological process or state; – concerning congenital physical or mental impairments; – concerning the predisposition to a medical condition or a disease; – to determine the safety and compatibility with potential recipients; – to predict treatment response or reactions; – to define or monitor therapeutic measures.

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IVD - Scope

• high-risk devices manufactured and used within a single

health institution, which are subject to most of the requirements set out in the proposal;

• tests providing information about the predisposition to a

medical condition or a disease (e.g. genetic tests) and tests providing information to predict treatment response or reactions (e.g. companion diagnostics), which are considered as in vitro diagnostic medical devices;

• medical software, which is explicitly mentioned in the

definition of IVDs..

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Unique Device Identifier System

• System related to identification and traceability of devices
• UDI-DI
• UDI-PI
• Appropriate Labels
• Storage of the UDI by economic operators, health institutions

and healthcare professionals

• Designated Entities – UDI operating system
• The UDI shall be used for reporting serious incidents and field

safety corrective actions

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IVD– Current Classification

• Classification of IVD products is based on positive listing (List A and B of

Annex II) and use for self testing

• Criteria for listing devices in list A and list B are associated with

– risk in blood transfusion / transplantation – prevention of AIDS and certain types of hepatitis – protection for newborns – minimizing long term damages due to certain illnesses

• All devices listed in Annex II and intended for self-testing (use by lay-

person) require participation of a Notified Body in Conformity Assessment

• All other IVD products do not require a Conformity Assessment under

participation of a Notified Body

• New classification is based on (former) GHTF classification Rules

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IVDR - Classification

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IVDR - Classification

Class D (Blood screening) – Classification Rule 1 Devices intended to be used to detect the presence of, or exposure to,

• a transmissible agent in blood, blood components, cells, tissues
• r organs, or in any of their derivatives
• a transmissible agent that causes a life-threatening disease with

a high or currently undefined risk of propagation

• determining the infectious load of a life-threatening disease

where monitoring is critical in the process of patient management

• Blood grouping ABO, Rhesus, Kell, Kidd and Duffy systems

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IVDR - Classification Class C – Rule 2

Devices intended to be used for

• blood grouping, or tissue typing to ensure the

immuno compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration

• except when intended to determine the previously

mentioned Class D blood grouping devices

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IVDR - Classification

Class C – Rule 3

Devices intended for

• detecting the presence of, or exposure to, a sexually transmitted agent;
• detecting the presence in cerebrospinal fluid or blood of an infectious

agent with a risk of limited propagation;

• detecting the presence of an infectious agent, if there is a significant risk

that an erroneous result would cause death or severe disability to the individual or fetus, or to the individual's offspring;

• pre-natal screening of women in order to determine their immune status

towards transmissible agents;

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IVDR - Classification

Class C – Rule 3 cont.

• for determining infective disease status or immune status, where there is

a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring;

• to be used as companion diagnostics;
• to be used for disease staging, where there is a risk that an erroneous

result would lead to a patient management decision resulting in a life- threatening situation for the patient or for the patient's offspring;

• to be used in screening, diagnosis, or staging of cancer;
• for human genetic testing;

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IVDR - Classification Class C – Rule 3 cont.

• for monitoring of levels of medicinal products, substances or biological

components, when there is a risk that an erroneous result will lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring;

• for management of patients suffering from a life-threatening disease or

condition;

• for screening for congenital disorders in the embryo or foetus;
• for screening for congenital disorders in new-born babies where failure to

detect and treat such disorders could lead to life-threatening situations or severe disabilities.

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IVDR - Classification

Class C – Rule 4

• Devices intended for self-testing with the exception
• f:

Class B – Rule 4

• detection of pregnancy, for fertility testing and for

determining cholesterol level, and devices for the detection of glucose, erythrocytes, leucocytes and bacteria in urine, which are classified as class B

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IVDR - Classification

Rule 4 Devices intended for near-patient testing are classified in their own right.

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IVD - Classification

Class B Rule 6

• Devices not covered by the above-mentioned

classification rules are classified as class B. Class B Rule 7

• Devices which are controls without a quantitative or

qualitative assigned value are classified as class B.

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IVD - Classification

Class A

• Products for general laboratory use/ accessories

which possess no critical characteristics

• Reagents, other articles with specific characteristics.
• Instruments intended specifically for use in IVD

procedures.

• Specimen receptacles.

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‐ ‐

‐

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Clinical Evidence Requirements

Clinical evidence will have to be collected for all IVD devices.

• Clinical data
• Performance evaluation

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Performance Evaluation

• Scientific Validity
• Analytical performance
• Clinical performance

Annually updated for Class C & D

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Clinical performance

• Clinical trial equivalent
• All IVD’s
• Single Member state application
• Clinical performance study plan and report

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Clinical Evidence References

• Regulation - Chapter VI Clinical evidence,

performance evaluation and performance studies

• https://lne-america.com/library/news/clinical-

evidence-requirements-of-in-vitro-diagnostic-devices

• http://webinars.lne.eu/medical/clinical-

performance-EU-IVD-Regulation/

• Dr. Julien Sénac

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Post-Market Surveillance

• Benefit-risk determination /risk management
• Design and manufacturing information, Labeling
• Performance evaluation
• Summary of safety and performance
• Preventive, corrective or field safety corrective

action;

• Usability, performance and safety
• Other devices PMS
• Trending

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Post-Market Surveillance

• PMS Plan
• PMS Report (Class A and B)
• Periodic safety update report (Class C and D)

– benefit-risk determination – PMPF – sales, estimate of the size and other characteristics ,usage frequency

• Class D – Notified body submission
• Class C – available to the notified body

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Vigilance

• Incident Reporting
• Trending
• Electronic system on vigilance and post-market

surveillance

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Eudamed

• Transparency
• Information access
• Single reporting
• Single database

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Next Steps

• No Grandfathering
• Transition for IVD will end in 2022
• Ensure correct classification of product
• Choose a conformity assessment
• Contact your notified body

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LNE/G-MED North America, Inc

Thank you! Any questions? https://lne-america.com/contact