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“Changes in Europe, Medical Device Regulations ”

MEDQURECopyright © 2017 , All rights reserved to MEDQURE IVS.

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Introduction

Micael Johansson

• Intertek SEMKO 1991-2007

– 2002-2007, ”Team Leader Safety Testing Medical and Laboratory” och ”Key Account Manager Medical Area”

• KTH, Masters degree 1997-2002

• 2007- 2011 Regulatory Affairs Manager, Maquet Critical Care AB

– Member of TK 62, TK 329 and ISO TC/121/SC3/JWG1

• 2011- 2013 Etteplan Stockholm Med tech, Site Manager

– Member of TK62 and TK 66

• Symbioteq 2013-2015 Senior Regulatory and Quality consultant

• NIMIO/MEDQURE IVS 2015-

• Provides courses at MEDQURE Such as”Usability”, ”SW and apps” and ”CE-marking acc to MDD/MDR”, ”IEC 60601”, ”IEC 61010”.

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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, 1 year anniversary•No memberships fee•Open and company specific courses•Very experienced instructors•Present in Denmark, English courses….•www.medqure.eu

• Soon in Sweden!

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•CE-marking of medical devices•MDD, IVD and AIMD

•Background to new regulation•New MDR/IVDR•In brief content of new regulations•Recommendations and strategies

Agenda

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Directive, MDD, Medical Device(MDD 93/42/EEC), being revised….

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Directive, AIMD, Active Implant Medical Device(AIMDD, 90/385/EEC), being revised….

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Directive, IVDD, In-vitro Diagnostic Device(IVDD, 98/79/EEC), being revised….

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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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New regulations for Medical devices

MDR 2017/174IVDR 2017/17526th May 2017

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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

New regulations – why?

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• Avoid scandals such as PIP……. or ?

New regulations – why?

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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, 2017/174

Regulation for in-vitro diagnostic medical devices

2017/175

”Skip” directive and national law!

26th of May

Directive

Law

Regulation

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Today

1200 pages plus another 80 legal texts

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Major 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 in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is 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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Economical operators; distributor/importer/EC rep. Example

Distributors shall: 1. Register the company if locally required in the country2. Verify the DoC and CE-mark of the products3. Verify the labeling and IFU of the product4. Handle the products correctly during transport/storage5. Not place the device on the market if he has reason to believe that a device is not in

conformity with the Regulation6. Inform the authorities if device presents a serious risk or is a falsified device7. Keep track of and handle; complaints, NC, field actions, installed base8. Upon request by authorities, provide free samples of the device or, grant access to the

device. Etc etc

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Person responsible for regulatory compliance

•Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.

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The requisite expertise 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 a course of study recognised as equivalent by

the Member State concerned, in law, medicine, pharmacy, engineering or another

relevant scientific discipline, and at least one year of professional experience in

regulatory affairs or in quality management systems relating to medical devices;

(b) four years of professional experience in regulatory affairs or in quality management

systems relating to medical devices.

Person responsible for regulatory compliance

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The person responsible for regulatory compliance shall at least be responsible for ensuring

that:

(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;

(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

(c) the post-market surveillance obligations are complied with in accordance with

Article 10(10);

(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;

(e) in the case of investigational devices, the statement referred to in Section 4.1 of

Chapter II of Annex XV is issued.

Person responsible for regulatory compliance

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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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Rule 11Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:– death or an irreversible deterioration of a person's state of health, in which case it is in class III; or a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.All other software are classified as class I.

Classification, software

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Rule 19All devices incorporating or consisting of nanomaterial are classified as:– class III if they present a high or medium potential for internal exposure;– class IIb if they present a low potential for internal exposure; and– class IIa if they present a negligible potential for internal exposure.

Classification, MDR

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Classification, MDR

• The quality management system shall address at least the following aspects:

(a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;

(b) identification of applicable general safety and performance requirements and exploration of options to address those requirements;

(c) responsibility of the management;

(d) resource management, including selection and control of suppliers and sub-contractors;

(e) risk management as set out in in Section 3 of Annex I;

(f) clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;

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Classification, MDR

(g) product realisation, including planning, design, development, production and service provision;

(h) verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29;

(i) setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83;

(j) handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;

(k) processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;

(l) management of corrective and preventive actions and verification of their effectiveness;

(m) processes for monitoring and measurement of output, data analysis and product improvement.

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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 certificationSterile, NB is needed.

B Devices for the detection of pregnancy, for fertility testing and for determining cholesterol level, and devices for the detection of glucose, erythrocytes, leucocytes 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.

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 requirementsMDD and IVD Annex I

• Annex I; Essential Requirements

• Annex I “General safety and performance requirements”

MDR §23 instead of§13 and more detailed requirements…

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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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Technical Documentation (MDR) Annex III

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

• The post-market surveillance plan

• PSUR = periodic safety update report (class IIa, IIb, III)

• Post-market surveillance report (class I)

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MDR - Post market

Further detailed activities required in post-market phase.

• Detailed plan/process for how to handle post-market; methods, tools, threshold/indicators, CAPA etc etc

• PMCFU part of plan

• Report required

• Required to be part of technical file, Annex III

• For all classes

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Unique Device Identification System (UDI)

• Harmonized with US requirements.

• FDA september 2014

• Article 27 in new MDR

• Different systems (GS1, GSEP etc)

•

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Unique Device Identification System (UDI)

• System shall include:

• Product identification, specific for each manufacturer and product (In DoC)

• Device identification, identify the manufactured product. Typical data:

• Date of manufacturing

• Serialno/batchno

• Devices in package

• ”Use by”-date

• Label on device or packaging

• Several levels

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Unique Device Identification System (UDI)

EUDAMED

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Clinical evaluation

• MEDDEV 2.7/1 rev 4, MDD to MDR

• Current interpretation for Notified bodies

• More focus on equivalence with other products

• Data required from competitor

• 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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For class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product, notified bodies should, except in certain cases, be obliged to request expert panels to scrutinise their clinical evaluation assessment report..

Clinical evaluation, MDR

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Clinial evaluation, summary

• Further/suitable resources necessary

• Redesign/update routines

• More data necessary/clinical and competitor

• In general deeper analysis

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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/evaluations

Summary, new regulations

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Transition periods:

- MDD/AIMD to MDR 3 year

- IVD to IVDR 5 year

- UDI different transition periods

- MDD/MDR in parallel

- May 2020 extension to May 2024

Summary, new regulations, when?

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Recommendations – To do List- for new MDR/IVDR

• 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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Recommendations – 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 management, investors, internally, economical operators etc

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Strategies for new MDR/IVDR

• Select appropriate NB

• Still in action? Reduced scope? Fully booked. MDR or not?

• MDR vs MDD

• Old devices in MDD? (above class I)

• Class I devices

• Changes in classes, SW etc?

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Strategies for new MDR/IVDR

• UDI

• 4, 6 and 8 years implementation

• IT strategy

• Tools clinical data, UDI, EUDAMED etc

• Product development, traceability etc

• GDPR (General data protection regulation)

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Questions?

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