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GRADUATE SCHOOL OF BIOMEDICAL ENGINEERING

BIOM 9410 REGULATORY REQUIREMENTS OF MEDICAL TECHNOLOGY

BIOM 9410

REGULATORY REQUIREMENTS OF MEDICAL


TECHNOLOGY

Module 9

Medical Device Regulation in


the European Union (EU)

LEARNING OUTCOMES
At the end of this module, you should be able to

• Describe the regulatory process in the European Union (EU) including the
role and function of Competent Authorities and Notified Bodies.

• Describe the system for classifying medical devices in the EU

• Determine the appropriate regulatory path for a range of medical devices in


the EU

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INTRODUCTION

Refer again to the Medical Device Product Development and Marketing Map
presented in Module 1. Interspersed along the timeline are stages where regulatory
bodies are involved in the review and assessment of the product development and
marketing of medical devices. Module 8 reviewed the functions of the FDA in the
regulation of medical devices in the USA. This module explores the regulatory
function in the European Union.

Originally, the European Union (EU) was a group of 15 member nations: Austria,
Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg,
The Netherlands, Portugal, Spain, Sweden and the United Kingdom. In May 2004,
ten additional countries, Cyprus, the Czech Republic, Estonia, Hungary, Latvia,
Lithuania, Malta, Poland, the Slovak Republic, joined the EU bringing the total
members to 25 countries. Bulgaria and Romania joined in 2007.

The main principles of the EU are the liberalisation of trade between its member
states, the realisation of a joint monetary unit and the development of a more
concrete economic cooperation in general and the development of joint defence and
safety policies. Harmonisation is a term used to describe the merging of the
philosophies and systems of the 27 member states. More information about the EU
can be found at http://europa.eu/.

The member countries of the EU collectively account for a large proportion of the
worldwide medical technology market and approval of a company’s medical device in
the EU is an important step toward the worldwide success of the device.

In this module, we will be accessing information primarily from the website of the
Medicines and Healthcare products Regulatory Agency (MHRA) in the United
Kingdom. http://www.mhra.gov.uk/home/groups/comms-
ic/documents/websiteresources/con2031677.pdf The URL in the module will take
you to the page where the MHRA offers documents providing guidance on the
various aspects of the regulations. There is a range of PDF files available on this
page all of which are named. Follow the directions in the text to locate each relevant
PDF file. Students from previous years have also found the Irish Medicines Board
Medical Devices website useful for information and its address is
http://www.hpra.ie/homepage/medical-devices

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THE EU MEDICAL DEVICES DIRECTIVES

A Directive is a legal instrument developed and passed by the European Union as a


whole and is then transposed into individual national laws by each of the member
States. As the EU cannot pass laws for each member state, the directive is passed
by the member states as a group and then each state passes a law in its own system
that enacts that directive in that state. For example, in the UK, one of the directives
relating to medical devices is enacted in The Medical Devices Regulations 1994 of
the Consumer Protection Act 1994. Harmonisation is thus achieved by having
equivalent laws in each Member State.

The Directives benefit medical device manufacturers by harmonising controls within


a single system and thus avoiding the need for manufacturers to comply with 15
different sets of rules. Purchasers and users can also be assured that devices
manufactured in the EU meet common standards of performance and safety.

For the purposes of the Directives, a medical device is defined as “any instrument,
apparatus, appliance material or other article, whether used alone or in combination,
including the software necessary for its proper application intended by the
manufacturer to be used on human beings for the purpose of:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease


• Diagnosis, monitoring, treatment or 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.

In the European Union, a series of three Directives regulate the safety and marketing
of medical devices. The Directives consist of Articles (very broad principles) and
Annexes (more specific requirements). They rely on Harmonised Standards such as
those drawn up by CEN (European Committee for Standardisation) and CENELEC
(European Committee for Electrotechnical Standardisation) to give technical detail.

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See the full text of the Directives at EUR-Lex (http://eur-lex.europa.eu/en/index.htm).

The Active Implantable Medical Devices Directive (90/385/EEC) covers all


powered implants that are left in the human body eg pacemakers and implantable
defibrillators.

The Medical Device Directive (93/42/EEC) covers all medical devices except active
implantable devices and in vitro diagnostic medical devices eg bandages, tongue
depressors, hip prostheses, X-ray equipment, ECG monitors and heart valves.

In Vitro Diagnostic Medical Device Directive (98/79/EC) covers all reagents, in


vitro diagnostic (IVD kits) and instruments etc. Implementing regulations came into
force on 7 June, 2000 and include a transitional period until 7 December 2003 after
which date manufacturers must comply.

KEY COMPONENTS OF THE DIRECTIVES


The main aim of regulatory submissions in the EU is for the manufacturer of a
medical device to be granted the right to place the CE Mark on the device. If the
device is CE Marked, it means that the device satisfies the relevant essential
requirements and is fit for its intended purpose as specified by the manufacturer.
You will have seen the CE mark on many products eg toys and mobile phones and
the process by which each product attains its CE mark can be dramatically different.
For example, the processes to obtain a CE mark for a pacemaker are far more
complex, time consuming and costly that those required to CE mark a set of wooden
blocks for a toddler. The fact that a CE mark is on a product, means only that the
requirements for that product have been met by the manufacturer. For more detail
about the CE Marking of medical devices, refer to https://www.gov.uk/medical-
devices-conformity-assessment-and-the-ce-mark

The degree of regulatory control which applies to a medical device is proportional to


the degree of risk that the device poses to the patient. The Directives describe the
Device classification procedures used by manufacturers to classify each device
and therefore define the regulatory requirements for that device. For more
information on device classification, http://ec.europa.eu/health/medical-
devices/files/meddev/2_4_1_rev_9_classification_en.pdf

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The Competent Authority is the body responsible for implementing the


requirements of the Directives in each member state. Each state’s Competent
Authority ensures that manufacturers comply with the Regulations, evaluates
adverse incident reports and carries out pre-clinical assessment of devices. The
Competent Authority for the UK is the Medicines and Healthcare products Regulatory
Agency (MHRA) and its website has a wide range of information on the directives
and regulatory matters in the EU at http://www.mhra.gov.uk/.

The Notified Body is an independent certification organisation that checks that


manufacturers of medium and high risk medical devices have followed the
requirements. For more details on the role of the competent authority, see
https://www.gov.uk/government/publications/notified-bodies-for-medical-devices

Conformity assessment is the process that the manufacturer is required to perform


to satisfy the relevant essential requirements and prove that it is fit for its intended
purpose. For more information on conformity assessment, see
https://www.gov.uk/medical-devices-conformity-assessment-and-the-ce-mark

THE CE MARK
By affixing the CE Mark to a medical device, the manufacturer is satisfied that his
product conforms with the relevant Essential Requirements in the Directives and that
it is fit for its intended purpose. More details about the CE Mark can be found at
https://www.gov.uk/medical-devices-conformity-assessment-and-the-ce-mark

THE COMPETENT AUTHORITY


The Competent Authority is the body that has the authority to act on behalf of a
Member State to ensure that the requirements of the medical devices Directives are
carried out in that particular Member State. Most Competent Authorities are
government organizations. For example, the Competent Authority in the UK is the
Secretary of State for Health who has delegated responsibility for the day to day
running of the Authority to The Medical Devices Directorate.

The role of The Competent Authority is determined by the Directives and consequent
national Regulations. Its primary aim is to ensure that all medical devices sold in the
Member State meet the Essential Requirements laid down in the Directives and in so

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doing, do not compromise the health and safety of patients, users and, where
appropriate, any other persons.

The general responsibilities of each Competent Authority include:

• negotiating the Directives on behalf of the government of the Member State,

• putting in place the necessary laws to give effect to the Directives,

• liaising and consulting with interested parties within government and the
healthcare industry,

• participating in EU Working Groups,

• publicising the provisions of the Directives and issuing appropriate guidance


to device users and manufacturers,

• advising on the Medical Devices Directives such as appropriate Conformity


Assessment routes and classification of devices and

• monitoring the effect of the Regulations and their burdens on business.

Specific tasks of the Competent Authority include:

• enforcing the Regulations in the member state

• liaising with the EC Commission if it considers that harmonised standards do


not meet the Essential Requirements

• membership of Standing Committees set up to provide opinions, advice and


guidance to Member States

• withdraw unsafe devices from the market

• resolving disputes between Notified Bodies and manufacturers

• ensuring adverse incidents are reported

• maintaining registers of Class I medical devices, custom made devices and


procedure packs

• handling all applications for clinical investigations

• designating Notified Bodies to carry out conformity assessment procedures

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The Competent Authority must ensure that

• all devices carrying the CE Mark meet the Essential Requirements


• devices not meeting the Essential Requirements are not allowed to carry the
CE Mark and
• except for devices marketed under transitional arrangements, only devices
carrying the CE Mark are placed on the market

THE NOTIFIED BODY


A Notified Body (NB) is

• A certification organisation which the Competent Authority of a Member


State designates to carry out one or more of the conformity assessment
procedures described in the annexes of the Directives.

• audit manufacturer’s production quality assurance system


• audit final testing and inspection
• by examination and testing of sample products
• examination of design dossiers (Class III only)

• An independent private sector third party

• authorised and audited by Competent Authority of the Member State

• authorized to conduct “third party” certification of compliance against the


Essential Requirements

Manufacturers are free to use any Notified Body in the EC capable of carrying out
the desired conformity assessment procedure. The responsibilities of a NB are:

• Where a manufacturer has chosen to follow the full quality assurance


route, the Notified Body will carry out an assessment of the manufacturer’s
quality assurance system. If the manufacturer is required to produce a
design dossier, the Notified Body will examine and evaluate it.
• Where a manufacturer has chosen to follow the type-examination route,
the Notified Body may use harmonised European standards to assess that
the essential requirements have been met. If necessary, the Notified Body
may devise its own means of assessing compliance with the essential
requirements.

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DEVICE CLASSIFICATION
The Medical Devices Directive which covers most devices established a four-part
classification system for medical devices. Annex IX of the Medical Devices Directive
(93/42/EEC) covers a vast range of products from first-aid bandages and walking
frames to CT scanners and non-active implants. The classification system is based
on matching the level of control on the device with the degree of risk inherent in the
device, the device’s degree of invasiveness and the length of time the device is in
contact with the body. Devices are categorised into four classes using 18 Rules:
• Rules 1 to 4 are for non-invasive devices
• Rules 5 to 8 are for invasive devices
• Rules 9 to 12 are additional Rules applicable to active devices
• Rules 13 to 18 are miscellaneous Rules for products which merit a higher
classification than they might otherwise be assigned.

Class I
• low risk
• most non-invasive products (some exceptions, see Class IIa)
• certain products that are invasive with respect to natural body orifices -
transient use
• reusable surgical instruments

Class IIa
• intermediate risk
• generally short term use
• non-invasive devices
• that channel and store blood for administration into the body
• connected to an active medical device in Class IIa or above
• some wound dressings
• surgically invasive with respect to natural body orifices - short term use
• surgically invasive devices - transient or short term use
• some active devices
• supplying energy or substances (not potentially dangerous)
• supplying energy or monitoring vital signs (non-critical care)
• administering/removing medicines/body substances (not potentially
hazardous)

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Class IIb
• intermediate risk
• non-invasive devices
• for body fluid modification
• some wound dressings
• invasive with respect to natural body orifices - long term use
• surgically invasive devices - long term use (general - see Class III)
• active devices
• supplying energy or substances (potentially dangerous)
• supplying energy or monitoring vital signs (critical care)
• emitting ionising radiation
• administering/removing medicines/body substances (potentially
hazardous)

Class III
• high risk
• invasive devices
• surgically invasive devices
• contacting heart and central circulatory system
• having a biological effect
• wholly or partly absorbed
• that undergo chemical change in the body (except teeth)
• that administer medicines
• devices incorporating medicinal products

EXERCISE
Work through the EU regulatory system with the same devices you used in the US
system to determine the class and regulatory pathway for each device. Make sure
that you cover all the topics available and read these in conjunction with the
summary notes on the major topics provided in this module.
• Cardiovascular surgical instruments
• Implantable pacemaker and
• Infusion pump

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ESSENTIAL REQUIREMENTS
The basic legal requirement for a medical device is compliance with the Essential
Requirements (Annex I of the MDD and Annex 1 of the AIMDD). The Essential
Requirements are presented as General Requirements and Requirements regarding
Design and Construction. The General Requirements are written in general terms
such as “devices must be designed and manufactured in such a way that … their use
does not compromise the clinical condition or safety of patients.” Requirements
regarding Design and Construction are more detailed and cover categories including
safety principles, packaging, biocompatibility, labelling and sterility, risk mitigation,
materials and electrical safety. A summary of the Essential requirements follows.

Essential Requirement 1
The device must be safe and any risks must be acceptable in relation to the benefits
offered by the device

Essential Requirement 2
The device must be designed in accordance with the latest knowledge eg as defined
in Standards. There must exist a risk mitigation strategy. Firstly, minimize risk by
design and secondly, use protection or alarm measures when risk cannot be
eliminated. Document residual risk.

Essential Requirements 3 and 4


The device must perform in accordance with the manufacturer’s specification. The
safety and performance must be maintained throughout the lifetime of the device.

Essential Requirements 5 and 6


The safety and performance of the device must not be affected by reasonable
conditions of transport and storage. Any side effects must be acceptable in relation
to the benefits offered.

Essential Requirements 7 to 14
• chemical, physical and biological properties
• infection and microbial contamination
• construction and environmental properties
• devices with a measuring function
• protection against radiation
• requirements for medical devices connected to or equipped with an energy
source
• information supplied by the manufacturer
• clinical

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CONFORMITY ASSESSMENT
The methods manufacturers use to demonstrate that devices comply with the
requirements of the Medical Devices Directives vary depending on which Directive
applies and on whether a device is classified as low, medium or high risk. These
methods known as conformity assessment procedures are set out in the annexes to
the Directives.

To demonstrate conformity, the device must first comply with the Essential
Requirements. The available routes of conformity assessment are them defined by
the class of medical device. Once the class is known, the procedures described in
Annexes II to VII of the MDD are followed. There is usually a choice given on paths
to follow and a summary of procedures available for each device class follows:

Class I devices:
• Manufacturer must review the rules to ensure the device is Class I
• Manufacturer declares conformity with the provisions of the Directive
including compliance with Essential Requirements (Annex VII)
• Manufacturer maintains sufficient technical documentation to permit
review if required
• Manufacturer must register the device with the Competent Authority
• Manufacturer must implement and maintain corrective action and
vigilance procedures
• Sterile and measuring devices are subjected to a limited degree of
intervention by a Notified Body. Intervention is limited to the sterility and
measuring aspects of the device (Annex IV, V or VI).

Class IIa devices


• Manufacturer declares conformity with the provisions of the Directive
including compliance with Essential Requirements (Annex VII)
• This declaration must be backed up with conformity assessment by a
Notified Body. This assessment may consist of:
• Audit of the production quality assurance system (Annex V) or
• Audit of product quality assurance - final inspection and testing
(Annex VI) or
• Examination and testing of sample products (Annex IV).

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Class IIb devices


• Notified Body carries out conformity assessment procedure consisting of:
• Full QA System review - an audit of the full quality assurance system
(covering every phase of the manufacture of a device from design
through to shipping – feasibility, design including written definition of
the device, design verification including creating prototypes, mass
production, full market release) (Annex II) or
• Type-testing or type examination (Notified Body reviews
documentation on a device and physically tests a prototype of the
device to determine if it meets certain standards) (Annex III) plus
some form of production audit to ensure consistency of product quality
– Product Verification (a sample from every batch is tested) (Annex
IV) or Production Quality Assurance including inspection and QA
techniques (Annex V) or Product Quality Assurance (inspection and
testing final products only) (Annex VI) or
• Sample examination

Class III devices


• As for Class IIb plus
• If the Full QA System review route is chosen, a design dossier must be
submitted to the Notified Body. Dossier may include specifications and
performance data as claimed, an explanation of how the product meets
the essential requirements for safety, risk analysis including risk control
methods, electrical/mechanical/chemical data including drawings, design
verification documents and clinical investigation data.
• If the Type Examination route is chosen, product quality assurance
(Annex VI) is not an option.

Active Implantable Medical Devices


• As for Class III devices plus
• If the Type Examination route is chosen, only options are Product
Verification using statistical verification (Annex 4) or Production Quality
Assurance including inspection and QA techniques (Annex 5).

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THE MEDICAL DEVICE DIRECTIVE (93/42/EEC)


The MD Directive includes 23 Articles and 12 Annexes and covers all medical
devices except active implantable devices and in vitro diagnostic medical devices eg
first aid bandages, tongue depressors, hip prostheses, X-ray equipment, ECG
monitors and heart valves.

The MDD:

• specifies “essential requirements” in Annex 1 which must be met by a


manufacturer before any device can be placed on the market including controls
covering the safety, performance, specification, design, manufacture and
packaging of devices,

• specifies requirements for assessment of clinical investigation protocols (Article


15) and the evaluation of any adverse incidents that occur (Article 10),

• introduces a system of classifying devices in Article 9 and Annex IX and


applies a level of control which is matched to the degree of risk inherent in the
device (Article 11 and Annexes II, III, IV, V, VI, VII and VIII),

• empowers a Competent Authority to identify and designate “notified bodies”


(Article 16 and Annex XI) who check and verify that devices meet the essential
requirements,

• requires that all medical devices must bear the CE Marking of conformity
(Article 17) when they are placed on the market. For sterile and “measuring”
devices, the CE Marking must be accompanied by the identification number of
the notified body that has acted under the relevant conformity assessment
procedure.

THE ACTIVE IMPLANTABLE MEDICAL DEVICE DIRECTIVE (90/385/EEC)


The AIMD Directive includes 17 Articles and 9 Annexes and covers all powered
implants that are left in the human body eg pacemakers and implantable
defibrillators. The AIMDD is similar to the MDD with the exception that the
classification system does not apply. All AIM devices are categorised together and
conformity assessment may be undertaken using the quality assurance route (Annex
2) or the EC type-examination 1 (Annex 3).

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THE IN VITRO DIAGNOSTIC MEDICAL DEVICE DIRECTIVE (98/79/EC)


An IVD is “any medical device which is a reagent, reagent product, calibrator, control
material, kit, instrument, apparatus, equipment 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 state, or
• Concerning a congenital abnormality, or
• To determine the safety and compatibility with potential recipients, or
• To monitor therapeutic measure.

IVDs include laboratory analysers, reagents, diagnostic kits and the like. For the
purposes of the IVDMDD, they are grouped into four categories according to the
risks associated with relative dangers to public health and/or patient treatment by an
IVD failing to perform as intended:
• General
• Self-testing
• Annex II List B – which includes test kits for rubella, toxoplasmosis and
phenylketonuria test kits as well as self test kits for blood glucose
• Annex II List A – which includes test kits for HIV, HTLV and hepatitis and some
blood grouping products including those used to test donated blood.

Once again the level of control is proportionate to the risk associated:


• General – manufacturer self-declares conformity with essential requirements of
the Directive.
• Self-testing – in addition to self-declaration, manufacturer submits details of the
device design to a Notified Body who assesses the design in terms of its
suitability for non-professional users.
• Annex II devices – manufacturer’s systems must be verified by a Notified Body
either via audit of the QA system (including design dossier review for List A
products) or type-testing and production audit or sample examination. For all
List A and some List B products, common technical specifications (CTSs) will
be developed to establish the performance characteristics of the device and be
used to demonstrate conformity with the Directive. List A products also require
batch release by the Notified Body.

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All IVDs must be CE marked before they are placed on the market.

AMENDMENTS TO THE EUROPEAN MEDICAL DEVICE DIRECTIVES


(2007/47/EC)
Late in 2007, The European Commission officially adopted a new Directive
(2007/47/EC) that amended parts of the Medical Devices Directive (93/42/EEC), the
Active Implantable Medical Devices Directive (90/385/EEC) and the Biocidal
Products Directive (98/8/EC). The existing Medical Device and Active Implantable
Medical Devices Directives remained in force and were amended by this new
Directive. All EU member states were asked to transpose this Directive into their
national law by December, 2008 and the new Directive was mandatory as of 21st
March, 2010. Here is a brief overview of major changes courtesy of Emergo Group.

1. Clinical data required for ALL devices, including Class I


The new Directive imposed more stringent requirements as to what constitutes
"clinical evidence" and mandated stronger enforcement by authorities. The definition
of "clinical data" was included and the Essential Requirements includes a
requirement for Clinical Evaluation according to Annex X, which was significantly
amended.

2. Records must be retained for 5+ years


Records must be maintained for inspection by Competent Authorities for the useful
life of the product or 5 years from date of manufacture, whichever is greater. For
implantable devices, records need to be kept for 15 years from the time the last
product was manufactured.

3. Class I (Sterile and Measuring) devices may now choose Annex II


Class I Sterile and Measuring devices have more flexibility to select a route to
compliance as they are given the option to select a full quality assurance conformity
assessment module.

4. Outsourced design and manufacturing must be more closely monitored


If the design or manufacturing of a device is done by a third party, you must
demonstrate that you have adequate controls in place to ensure the continued
efficient operation of the supplier's quality system.

5. Closer inspection of design documentation

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Notified Bodies are required to perform an inspection of design documentation for a


representative sample of devices using industry standard statistical techniques and
commensurate with the risk of the device.

6. Appointment of an Authorized Representative (AR) explicitly noted


The AR has a mandate to act, and be contacted, in lieu of the manufacturer in terms
of meeting the obligations by the Directives for all classes of devices.

7. Software is now clearly defined as an active medical device


It does not matter whether the software is integral with the device or is a standalone
product. Software validation is also an Essential Requirement.

8. Custom devices now subject to post market surveillance


Custom devices require a post-market surveillance system that is reportable to
Competent Authorities.

9. Instructions for Use (IFU) must now be revision controlled


Where appropriate, the new Directive states that the date of issue or latest revision
of the IFU must be clearly indicated.

10. Borderline products


Whether a product is classified as a medicinal product or device is now determined
by the Primary Mode of Action rather than by the Intended Use.

11. Definition of central circulatory system has been expanded


Now includes the vessels, aortic arch (arcus aortae) and descending aorta (aorta
descendens) to the aortic bifurcation (bifurcatio aortae). Devices are Class III.

12. Definition of continuous use has been expanded


Now includes situations where a device, upon discontinuation or removal, is replaced
immediately by the same or with an identical device. This impacts the classification
of certain devices.

13. European databank


Data related to clinical investigations is now collected for the European databank and
shared among Competent Authorities. The databank also includes information on
registration, Authorized Representative, certificates and vigilance data. The data
must be submitted in a standardized format. The Directive states that the databank
must be operational by September 2012.

14. Human tissue

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Devices that incorporate human tissue, blood or plasma fall within the scope of
Directive 2001/83/EC and are considered Class III.

UPDATE ON EUROPEAN MDD CHANGES EFFECTIVE MARCH 2010.


In May 2009, the EC released an interpretative document of Directive 2007/47/EC,
providing clarification on certain issues within the Directive. The document is
attached to this module and you should read it and understand the implications.

In summary, it is seen that the major changes made by Directive 2007/47/EC are

• All medical devices, regardless of class, require full clinical evidence to be


documented before placing on the market.

• Annex IX definition of Active Medical Device has been amended to expressly


include software. This will result in the reclassification of a number of devices
previously regarded as Class I, particularly involving diagnostic software,
which are now considered active devices for diagnosis and classified as IIa
under classification rules.

• Software validation requirements have been clarified with new Essential


Requirement 12.1a requiring software to be validated according to the state
of the art.

• A revised definition at Article 1 5(c) expressly states that the test of whether a
product is a drug or device will be the primary mode of action rather than the
manufacturer’s stated Intended Purpose. This may result in the shift of a
number of borderline products from regulation as devices to regulation as
medicines.

• The Directive has been updated to expressly require implementation of


postmarket systems, irrespective of device class or means of conformity
assessment.

SUMMARY
1. In the European Union, a series of three Directives describe regulation of the
safety and marketing of medical devices.

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2. The main aim of regulatory submissions in the EU is for the manufacturer of a


medical device to be granted the right to place the CE Mark on the device.
3. The degree of regulatory control which applies to a medical device is proportional
to the degree of risk that the device poses to the patient. The four part Device
classification procedures used by manufacturers are described in the Directives.
4. A Competent Authority is the body responsible for implementing the requirements
of the Directives in each member state.
5. A Notified Body is an independent certification organisation that checks that
manufacturers of medium and high risk medical devices have complied with
requirements.
6. Conformity assessment is the process performed by the manufacturer to satisfy
the relevant essential requirements and prove that the device is fit for its intended
purpose.
7. Postmarket surveillance by the manufacturer is a requirement of the EU system.

EXERCISE
Access the following articles from the UNSW electronic library and read other articles
relating to medical device regulatory approvals in the EU and USA. Summarise and
compare the major attributes of the regulatory systems in these two jurisdictions and
the activities in place to harmonise the two systems.

Eidenberger, Reiner. Medical device registration, agreements on mutual recognition


– a step forward to global harmonization? Radiation Physics and Chemistry; 2000;
57(3-6):539-542.

Wilmshurst. The Regulation of Medical Devices. BMJ; 2011; 342:d2822.

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