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“Seminar om de nye regler for certificering”

Welfare Tech, MEDQURE IVS, GS1 and InfoCura

Copyright © 2016 , All rights reserved to MEDQURE IVS.

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Introduction

Micael Johansson, Senior Quality/Regulatory consultant and partner MEDQURE.

25 years in regulatory/quality/development.

Background:

- Test house/Notified Body (Intertek)

- Product development of Critical care ventilator/anesthesia work station (MAQUET)

- Senior consultancy (Various start-ups and international companies)

Email : micael.johansson@nimio.se / mj@medqure.eu

Tele: +46-73 070 10 44

www.medqure.eu , MEDQURE IVS, Kristian and Micael on Linked-in

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What is MEDQURE

• Course provider for medical device companies •New player •No memberships fee •Open and company specific courses •New concept; networking, training, share experience

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Agenda

• Introduktion: begreber og generelle forventninger • What is CE-marking • Why does a product need to be CE-marked • Which directives exist and which are applicable for medical devices • Intro to the medical device directives, MDD, IVD and AIMD • SW/Apps as medical device (short)

• Er I parate til den nye forordning om CE-mærkning? • Background • What applies already now • In brief content of new regulations (draft) • Recommended Actions & ‛To do list‛ • Impact

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Background – why CE-marking?

• Safe products onto the market • Be able to sell all over Europe • Harmonize product responsibilty

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CE-marking and ”New Approach”

Based on some basic principles

• Directives/regulations shall be limited to regulate basic safety and health/environment aspects.

• Technical/detailed requirements shall be in the form of harmonized standards.

• Product is manufactured/developed according to harmonized standards are presumed to meet the basic safety and health aspects.

• Standards shall not be mandatory.

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Conformité Europèene (CE)

• Proof to the concerned authority that the product meets the applicable directives/laws and regulations for the specific product.

• Not all products need CE

• Scope

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Conformité Europèene (CE)

0413, 0043, 0123 etc

Notified Body

‘notified body’ means a conformity assessment body designated in accordance with the regulation;

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Conformité Europèene (CE)

• Declaration of Conformity (by manufacturer)

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Conformité Europèene (CE)

• EC certificate (by Notified Body)

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Directive vs law vs regulation

• EU directive conforms to national law and regulation (föreskrift/förordning) in each country.

Directive

Law

Regulation

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EU-directives

Area Swedish authority

• Low voltage directive (2014/35/EU ) Elsäkerhetsverket

• Electromagnetic compatibility (2014/30/EU) Elsäkerhetsverket

• Toys (2009/48/EC ) Konsumentverket

• Personal protective equipment (PPE) (89/686/EEC) Arbetsmiljöverket/Konsumentverket

• Pressure Equipment (PED) (2014/68/EU) Arbetsmiljöverket

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Area Swedish authority

• Machinery directive (2006/42/EG) Arbetsmiljöverket

• Waste Electric and Electronic Equipment (2002/96/EG) WEE Naturvårdsverket

• Restriction of use of certain Hazardous Substances (2002/95/EG )*, Kemikalieinspektionen

ROHS 2

• Registration, Evaluation, Authorisation and Restriction Kemikalieinspektionen of Chemical substances, (1907/2006/EG), REACH

*ROHS required for Medical Devices 2014 (2016 in vitro diagnostic medical devices)

EU-directives

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Area Swedish authority

• Radio Equipment Directive (RED) 2014/53/EU Post- och Telestyrelsen

• Measuring instruments (MID)(2004/22/EG) SWEDAC

• Battery directive (2006/66/EG) Naturvårdsverket

EU-directives

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EU-directives, Medical

Area Swedish authority

• Medical Device Directive (MDD, 93/42/EEC) Läkemedelsverket

• Active Implant Medical Device Directive , (AIMDD, 90/385/EEC) Läkemedelsverket

• In-vitro diagnostic Device Directive (IVDD, 98/79/EEC) Läkemedelsverket

• Notifed Body, as Intertek/SP in Sweden and Presafe in Denmark, are the authorities ‛prolonged arm‛

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Directive, MDD

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Scope MDD

medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

— diagnosis, prevention, monitoring, treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

— investigation, replacement or modification of the anatomy or of a physiological process,

— control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means

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Directive, AIMD

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Directive, IVDD

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Software/App vs ”Real device”

• No difference, ‚Intended use‛ essential

• Embedded or stand alone?

• Embedded together with device

• Consider where to ‛put onto the market‛

• Other regulations will apply

• As for all devices, specific requirement/standards for SW

• Tricky with health apps

• Often accessory

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Examples of software that is medical device

• Apps that transfers data from the body: for example, Temperature, pulse, pulse / oxygen combination, different types of ECG, (data input from e.g. a sensor or entered manually)

• Blood Glucose Meters app

• Supports drug treatment by "coaching" the patient

Software/App vs ”Real device”

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New regulations for Medical devices

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Disclaimer

•Presentation is based on current information, draft

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New regulations for medical devices

Council Directive 90/385/EEC on active implantable medical devices (AIMDD)

Council Directive 93/42/EEC on medical devices (MDD)

Council Directive 98/79/EEC on in vitro diagnostic medical devices (IVDD)

Regulation for medical devices

Regulation for in-vitro diagnostic medical devices

No directive and no national law!

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New regulations – why?

EU’s framework is not up-to-date with either current technology or scientific development

o IVD not updated since 1998

o Home healthcare

o eHealth and mHealth

o Drug/device – combinations

o Nanotechnology

o Etc.

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o Different EU member countries interpret and implement existing requirements in different ways…..

New regulations – why?

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o Poor traceability for products

o Insufficient access to important information – transparency necessary!

New regulations – why?

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• Avoid scandals such as PIP……. or ?

New regulations – why?

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Notified bodies undergo an inspection procedure, joint assessment

- Several notified bodies have lost their license/part of a license to operate

- Extremely tough assessments with participants from commissions and authorities with high expertise

- Several deviations to handle

- NB are recruiting

Applicable parts of the new regulation

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- 2500 certificates need re-certification

- Usually need a lot of work for these certificates/technical files ....

- New/start-up companies want Notified Bodies services

- Tougher reviews of technical files and audits

- Notified Bodies are fully booked

Applicable parts of the new regulation

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• Increased market control

• Increased coordination between NB and authority

• Unannounced audits / inspections

Applicable parts of the new regulation

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Drafted changes

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Scope, Aesthetic or other non-medical purpose

Certain groups of products for which the manufacturer claims only an aesthetic or another non-medical purpose but which are similar to medical devices in terms of functioning and risks profile should be covered by this Regulation. In order for manufacturers to be able to demonstrate conformity of such products, the Commission should adopt common specifications at least on application of risk management and, where necessary clinical evaluation regarding safety applicable to those products. These common specifications should be developed specifically for a group of products without a medical purpose and should not be used for conformity assessment of the analogous devices with a medical purpose.

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New classification, ”reusable surgical instruments”

• Notified body also necessary for ‚reusable surgical instruments‛

• Same level as Class I sterile and for measurement devices

• ‚Reusable surgical instrument’ means an instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device and which are intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out. ‚

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EUDAMED?

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Person responsible for regulatory compliance

•Person responsible for regulatory compliance

Manufacturers shall have available within their organization, at least one qualified person responsible for regulatory compliance who possesses expert knowledge in the field of medical devices.

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The expert knowledge shall be demonstrated by either of the following qualifications:

• (a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an a course of study recognized as equivalent course of study, in natural sciences, by the Member State concerned, in medicine, pharmacy, engineering or another relevant scientific discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to medical devices;

• (b) five years of professional experience in regulatory affairs or related to devices including experience in quality management systems relating to medical devices

Person responsible for regulatory compliance

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MEDDEV

Today's existing interpretative documents; MEDDEV:

•The plan is that all existing MEDDEV will be incorporated into the legislation

•New MEDDEV will probably be worked out afterwards

In general enhanced level, such as clinical evaluation

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• Invasive devices

•Active implantable medical devices, Class III

• Surgical meshes, Class III

•Breast implants, Class III

• Spinal disc replacement implants, Class III

•Active devices

• SW own classification

• Special rules

•Nanomaterial (Class IIa, IIb and III)

Classification, 22 rules instead of 18, MDR

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5.2a. Rule 10a Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes, is in class IIa, except if such decisions have an impact that may directly or indirectly cause: - the death or an irreversible deterioration of the state of health, in which case it is in class III; - a serious deterioration of the state of health or a surgical intervention, in which case it is in class IIb. Software intended to monitor physiological processes is in class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, in which case it is in class IIb. All other software is in class I.

Classification, software

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‚For class III implantable medical devices and Class IIb active medical devices intended to administer and/or remove a medicinal product experts panels should be requested, notwithstanding certain exemptions, to scrutinise the preliminary assessment conducted by notified bodies…..‛

Classification, MDR

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Classification, MDR

Article 8 requires, ‚General obligations‛

Proportionate to the risk class and the type of device, manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this regulation in the most effective manner.

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• In vitro diagnostic medical devices are classified into four risk classes:

•A (low risk), B, C and D (high risk)

• Many companies will be required to set up a QMS

• Scrutiny panel may apply for class D

Classification, IVDR

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Classification IVDR

Class Examples Assessment

A Products for general laboratory use, buffer solutions, washing solutions, and general culture media and histological stains

Self certification Sterile, NB is needed.

B Self-detection of pregnancy, for fertility testing, or determining cholesterol level, detection of glucose and bacteria in urine

NB control of quality management system

C Detecting the presence of a sexually transmitted agent , screening, diagnosis, or staging of cancer. Devices intended for self-testing.

Class B + technical documentation

D HIV, Syphilis, Ebola blood testing

Class C + type examination. Scrutiny panel in some cases

R I

S K

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General safety and performance requirements

MDD and IVD Annex I

• Annex I; Essential Requirements

Becomes….

• Annex I ‚General safety and performance requirements‛

§19 instead of §13 and more detailed requirements…

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Clinical evaluation

• In general higher requirements on the evaluation report and PMCF (post market clinical follow-up)

• High risk device to scutiny panel

• Clinical data for Class III is a must!

•How to get data?

•How to handle variants, MDR not written for that?

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Clinical evaluation

• MEDDEV 2.7/1 rev 4

• Current interpretation for Notified bodies

• More focus on equivalence with other products

• Usability proof necessary

• More focus on PMS/PMCF

• Higher requirements on competence for person doing evaluation

• TGA (Australia)/Health Canada/PMDA (Japan)/CFDA (China) raise the bars towards the MEDDEV

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Technical Documentation (MDR) Annex II

The technical documentation to be drawn up by the manufacturer shall include in particular the

following elements:

1. Device description and specification, including variants and accessories

2. Information supplied by the manufacturer

3. Design and manufacturing information

4. General safety and performance requirements

5. Risk/benefit analysis and risk management

6. Product verification and validation (incl. pre-clinical and clinical data)

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• Extended, clearer scope for the medical device regulations - new products are coming in. Also non-medical devices

• Revised classification, especially IVDR

• In general enhanced requirements

• More extensive review of NB quality system and Technical file

• Clearer rights and obligations (responsibility) for the manufacturers, importers and distributors

• Extended Eudamed database - more information available

Summary, new regulations

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• Better traceability through the entire value chain

• Stricter requirements for clinical data

• Better coordination between authorities

Summary, new regulations

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Higher costs in all areas

- EUDAMED, scrutiny panel, assessements for authority

- Increased competence and documentation requirements for Notified Body

- UDI / Requirements for QA / RA skills / Increased documentation requirements for companies

Summary, new regulations

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What could this cost?

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With permission from: Dr. Susana de Azevedo Wäsch , Gestlich Head of Global Regulatory Affairs

Class III implants

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Draft agreed (june) and finalization is in progress:

- December 2016

- MDD 3 year transition

- IVD 5 year transition

- UDI different transition periods

Summary, new regulations, when?

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Planning – To do List- for new MDR/IVDR

• Select appropriate NB

• Increase internal/external training

• Evaluate resources, right competence etc

• Evaluate time to market

• Enhanced lead/review times

• Internal work

• Evaluate additional cost

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Planning – To do List- for new MDR/IVDR

• Perform gap analysis

• Plan for PMCF and clinical evaluations

• Update/raise SOP and templates

• Update technical documentation

• Communicate to investors and stakeholders

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Impact for manufacturers

• All departments, marketing/sales, finance, HR, logistics, development, production, regulatory/quality – all!

• Suppliers

• Authorized representatives

• Investors

• Companies outside EU who want access to the market

• ‛Non-medical‛ device companies must comply

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Questions?

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