EU Glossary

Question 1

Abridged Application

Answer 1

An application for marketing authorisation that, based
upon demonstrating essential similarity or by detailed references to published scientific literature, does not contain the results of pharmacological and toxicological tests or the results of clinical trials.

Question 2

Accessory

Answer 2

An article that while not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the device’s use intended by the device manufacturer.

Question 3

Acquis Communautaire

Answer 3

Usually referred to as the Acquis, the collection of European laws to which all EU Member States must adhere.

Question 4

Active Implantable Medical Device

Answer 4

Intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.

Question 5

Active Implantable Medical Devices Directive

Answer 5

(AIMDD) First EU medical device legislation; sets general
requirements relating to the design, construction and
CE-Marking of these devices and their accessories.

Question 6

Authorised Representative

Answer 6

A natural or legal person established in the EU who, explicitly designated by a non-European manufacturer, acts on the manufacturer’s behalf in carrying out certain tasks required in the applicable directives.

Question 7

Batch Recall

Answer 7

The action of withdrawing a batch from the distribution
chain and users. A batch recall may be partial, in that the
batch is withdrawn only from selected distributors or users.

Question 8

Blue Box

Answer 8

The location where country-specific text usually is usually placed on packaging materials and leaflets for medicinal
products approved via the Centralised Procedure.

Question 9

CAMD

Answer 9

Competent Authorities for Medical Devices

Question 10

CE Marking

Answer 10

European Conformity, Conformité Européenne, marking.
Mandatory European marking for products falling under
one of the New Approach directives (including medical
devices) to indicate conformity with the essential health
and safety requirements.

Question 11

Clinical Investigation Plan

Answer 11

(CIP) Document stating a clinical investigation’s rationale,
objectives, design and proposed analysis, methodology,
monitoring, conduct and recordkeeping.

Question 12

Combination Product

Answer 12

Product that shares the attributes of two product categories

such as medical devices and medicinal products.

Question 13

Common Technical Specifications

Answer 13

(CTS) A set of requirements published in the Official

Journal of the European Union and currently applicable only to the Annex II List A IVD products.

Question 14

Competent Authority

Answer 14

For medical devices, the organisation authorised by a
Member State’s government to act on its behalf to ensure all
medical devices meet the Essential Requirements laid down
in the medical device directives.

Question 15

Compliance and Enforcement Group

Answer 15

(COEN) Focuses on the scope and better coordination of
enforcement activities by Member States, and considers how
communications and cooperation between Member States
can be made more effective and efficient.

Question 16

Conformity Assessment

Answer 16

The systematic examination of evidence generated and
procedures undertaken by the manufacturer, under requirements
established by the regulatory authority, to ensure
a medical device is safe and performs as intended by the
manufacturer and, therefore, conforms to the Essential
Principles of Safety and Performance for Medical Devices.

Question 17

CTA

Answer 17

Clinical Trial Application

Question 18

CTD

Answer 18

Common Technical Document

Question 19

Custom-Made Device

Answer 19

Any device specifically made in accordance with the written
prescription of a duly qualified medical practitioner or any
other person authorised by virtue of professional qualifications
to do so that gives, under the prescriber’s responsibility,
specific design characteristics and intended for the sole use
of a particular patient.

Question 20

Declaration of Conformity

Answer 20

A document whereby the manufacturer ensures either
the product safety component satisfies the Essential
Requirements of the applicable directives, or the product
is in conformity with the type for which a type-examination
certificate has been issued and satisfies the Essential
Requirements of the applicable directives. This declaration
is issued after completion of all relevant conformity assessment
procedures and must, in any case, be drawn up before
the product is placed on the market; as a general rule, it
accompanies the product bearing the CE marking.

Question 21

Direct Healthcare Professional Communication

Answer 21

(DHCP) A letter sent directly to individual healthcare
professionals by a marketing authorisation holder or a regulatory
authority, containing information or advice regarding
the use of a medicine.

Question 22

Directive

Answer 22

An EC decision binding on EC institutions and Member
States that must be transposed into national legislation.
However, the way in which it is implemented is left to the
discretion of individual Member States.

Question 23

Distributor

Answer 23

Any natural or legal person in the supply chain, other than
the manufacturer or importer, who makes a product available
on the market.

Question 24

ECTR

Answer 24

European Clinical Trial Regulation

Question 25

Essential Requirements

Answer 25

Technical requirements defined in each New Approach
directive (usually Annex 1) with which a product must
comply to qualify for CE Marking.

Question 26

EU Legal Representative

Answer 26

(EU-LR) An individual, company, institution, or organisation
authorised to act on behalf of the sponsor of a clinical
trial when the sponsor is not legally established in the EU.
The Legal Representative must be based in the EU or the
EEA, which includes Iceland and Norway (Article 15 of
Dir 2001/20/EC).

Question 27

European Economic Area

Answer 27

(EEA) A free-trade area, in all but agriculture, comprising
the EU Member States plus Iceland, Liechtenstein and
Norway. Previously called the European Economic Space.

Question 28

European Standard

Answer 28

(EN) Standards harmonised across the EU whose use, in
theory, is voluntary. They address product health or safety
aspects, as well as such other characteristics as durability,
appearance, quality levels or even cultural preferences. These
standards may be test methods or measurement guides.

Question 29

European Union

Answer 29

(EU) Political body comprising 28 Members States established
by the 1993 Treaty of Maastricht. It is the de facto
successor to the European Economic Community founded
in 1957 by the Treaty of Rome.

Question 30

Field Safety Corrective Action

Answer 30

(FSCA) An action taken by a manufacturer to reduce the
risk of death or serious deterioration in the state of health
associated with the use of a medical device already placed
on the market.

Question 31

Field Safety Notice

Answer 31

(FSN) A communication from a manufacturer or its representative
to customers and/or users in relation to a Field
Safety Corrective Action.

Question 32

General Safety and Performance Requirements

Answer 32

(GSPRs) Under the new EU Medical Device Regulations
and EU In Vitro Device Regulations, the set of requirements
stipulating the safety principles for medical device design
and manufacture to ensure patient, user and third party’s
health and safety are protected

Question 33

Helsinki Procedure

Answer 33

Used by a national Competent Authority to request other
national Competent Authorities to provide an opinion on
a specific borderline or classification issue.

Question 34

ICH

Answer 34

International Council on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for
Human Use

Question 35

In Vitro Diagnostic Devices Directive (IVDD)

Answer 35

Covers devices used in vitro to examine specimens derived
from the human body, including reagents, instruments and
specimen receptacles.

Question 36

Importer

Answer 36

Any natural or legal person established within the
Community who places a product from a third country on
the Community market.

Question 37

ISO

Answer 37

International Organization for Standardization

Question 38

Joint Audit Programme

Answer 38

(JAP) Validates and verifies the implementation of relevant
EU directives’ provisions into national laws; manufacturers’
authorisation and licensing systems; GMP compliance
certification; administration of inspections; inspectorate;
resources; complaints; rapid alerts including laboratory
support, enforcement and internal quality assurance. The
JAP covers all EEA GMP inspectorates for human and
veterinary medicinal products.

Question 39

MA

Answer 39

Marketing Authorisation

Question 40

MAA

Answer 40

Marketing Authorisation Application

Question 41

MAH

Answer 41

Marketing Authorisation Holder

Question 42

MAID

Answer 42

Manufacturer, Authorised Representative, Importer and
Distributor (medical devices). The economic operators
covered by the new supply chain regime under the IVDD.

Question 43

Marketing Authorisation

Answer 43

(MA) Authorisation to place a medicinal product on
the market in a Member State issued by its Competent
Authority or by EMA for the EU market.

Question 44

Marketing Authorisation Application

Answer 44

(MAA) The application submitted to a Member State(s)
for a Decentralised or Mutual Recognition Procedure or to
EMA for the Centralised Procedure seeking permission to
place a new product on the market.

Question 45

Marketing Authorisation Holder

Answer 45

(MAH) The person or company holding the marketing
authorisation for placing a medicinal product on the market and responsible for marketing the product. The MAH must
be established in the EEA.

Question 46

Medical Devices Directive

Answer 46

(MDD) The Medical Devices Directive (Directive 93/42/
EEC) sets general requirements relating to the design and
construction of medical devices and their accessories.

Question 47

Medical Device Expert Group

Answer 47

(MDEG) A group of Member State, industry and other
stakeholder representatives in the medical device area for
implementing the directive. This is the umbrella group
for other working groups in the field and coordinates and
oversees their activities.

Question 48

Member State

Answer 48

An EU member nation. EFTA States have adopted the
complete Acquis Communautaire on medicinal products
and consequently are parties to Community procedures;
therefore, for the purposes of this book, the term Member
State also shall include EFTA countries.

Question 49

Mutual Recognition Procedure

Answer 49

Applicable to most conventional medicinal products, the
Mutual Recognition Procedure is based on extending
national marketing authorisations to one or more additional
Member States. Applicants may select the Reference
Member State to conduct the assessment and applicable
Concerned Member States where the product would be put
on the market if approved.

Question 50

New Approach Directives

Answer 50

The European Council’s Decision of 7 May 1985 established
a “New Approach” for technical harmonisation and
standardisation to remove technical trade obstacles within
the EU. The New Approach serves inter alia as the basis for
the European Council medical device directives issued thus
far with the object of removing existing trade obstacles and
achieving high unified security standards.

Question 51

Notice to Applicants

Answer 51

(NTA) Procedures for marketing authorisation, regulatory
guidelines and application dossier presentation and content
for medicinal products for human use (Volume 2) and veterinary
medicinal products (Volume 6). The NTA has no
legal force.

Question 52

Notified Body

Answer 52

Certification organisation (e.g., independent testing house,
laboratory or product certifier) authorised by the relevant
Member State’s Competent Authority to perform conformity
assessment procedures specified in the medical devices
directives.

Question 53

Notified Bodies Operations Group

Answer 53

(NBOG) Contributes to improving the overall performance
of Notified Bodies in the medical devices sector primarily by
identifying and promulgating examples of best practice to
be adopted by both Notified Bodies and those organisations
responsible for their designation and control.

Question 54

Official Journal

Answer 54

(OJ) Official Journal of the European Union. Contains details
of all EU legislation, as well as draft legislation, information,
notices and advertisements for public works and supplies
contracts.

Question 55

Parallel Consultation

Answer 55

The European Medicines Agency (EMA) offers consultations
in parallel with the European Network for Health
Technology Assessment (EUnetHTA) as of July 2017. This
aims to allow medicine developers to obtain feedback from
regulators and health technology assessment (HTA) bodies
on their evidence-generation plans to support decisionmaking
on Marketing Authorisation and reimbursement
of new medicines at the same time.

Question 56

Qualified Person

Answer 56

A person at the Marketing Authorisation Holder’s disposal
responsible for ensuring the quality of each medicinal
product is in accordance with the marketing authorisation’s
requirements.

Question 57

Regulation

Answer 57

A legal act entirely and directly binding on Member
States. Unlike a directive, it does not require transposition
into national law and its provisions can come into force
immediately.

Question 58

Risk Management Plan

Answer 58

(RMP) A set of pharmacovigilance activities and interventions
designed to identify, characterise, prevent or minimise
risks relating to a medicinal product, including the assessment
of the effectiveness of those interventions.

Question 59

Sunset Clause

Answer 59

The cessation of a medicinal product’s marketing authorisation,
if the product is not placed on the market within
three years of the authorisation being granted, or where a
medicinal product previously placed on the market is no
longer present on the market for three consecutive years.

Question 60

Type I Variation

Answer 60

Any of the “minor” documentation variations listed in
Annex I of Regulations (EEC) 1084/2003 (formerly
541/95) and (EEC) 1085/2003 (542/95) to an approved
marketing authorisation. A Type IA or Type IB variation
notification must be filed with EMA for any such change.
Type IAIN requires immediate notification.

Question 61

Type II Variation

Answer 61

Any change to an approved MA’s documentation that is not
a Type IA or Type IB Variation and is not regarded as an
extension to the MA.