European Union Medical Device Directives

1. EU MDD
93/42/ECC
WITH RESPECTTO CLINICAL
RESEARCH
By- AARTIVATSA
MPHARMA, 1ST SEM (DRA)

2. TABLE OF CONTENT:
• Device Directives (CE Marking)
• Definitions
• MDD 93/42/ECC- Compliance
• MDD 93/42/ECC shall not apply to
• Articles
• Annexure(annex)

3. Device Directives (CE Marking):
• Medical Devices (MDD) – 93/42/EEC
• Active Implantable (AIMDD) - 90/385/EEC
• In-Vitro Diagnostics (IVDD) – 98/79/EC
Council Directive 2001/83/EC - Device is assembled by device is
placed on the market in such a way that the device and the medicinal
product form a single integral product which is intended exclusively for
use in the given combination and which is not reusable 3

4. Definitions
Medical Device- 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:
o diagnosis, prevention, monitoring, treatment or alleviation of disease,
o diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
o investigation, replacement or modification of the anatomy or of a physiological process,
o 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;

5. • Custom- mode Device- any device specifically made in accordance with a duly
qualified medical practitioner's written prescription which gives, under his
responsibility, specific design characteristics and is intended for the sole use of a
particular patient.
• Device intended for clinical investigation- any device intended for use by a duly
qualified medical practitioner when conducting investigations as referred to in
Section 2.1 of Annex X in an adequate human clinical environment.
• Manufacturer- The natural or legal person with responsibility for the design,
manufacture, packaging and labelling of a device before it is placed on the market
under his own name, regardless of whether these operations are carried out by
that person himself or on his behalf by a third party.
• Notified Body- An entity that has been accredited by a Member State to assess
whether a product to be placed on the EU market meets certain preordained
standards.

6. • Intended purpose- The use for which the device is intended according to the data
supplied by the manufacturer on the labelling, in the instructions and/or in
promotional materials.
• Placing on the market- The first making available in return for payment or free of
charge of a device other than a device intended for clinical investigation, with a
view to distribution and/or use on the Community market, regardless of whether it
is new or fully refurbished.
• Putting into service -The stage at which a device has been made available to the
final user as being ready for use on the Community market for the first time for its
intended purpose.

7. • Authorised representative- Any natural or legal person established in the
Community who, explicitly designated by the manufacturer, acts and may be
addressed by authorities and bodies in the Community instead of the
manufacturer with regard to the latter's obligations under this Directive.
• Clinical data- The safety and/or performance information that is generated from
the use of a device. Clinical data are sourced from: — clinical investigation(s) of the
device concerned; or — clinical investigation(s) or other studies reported in the
scientific literature, of a similar device for which equivalence to the device in
question can be demonstrated; or — published and/or unpublished reports on
other clinical experience of either the device in question or a similar device for
which equivalence to the device in question can be
1.Device subcategory A set of devices having common areas of intended use or
common technology.
2. Generic device group A set of devices having the same or similar intended uses or
commonality of technology allowing them to be classified in a generic manner not
reflecting specific characteristics.
3.Single use device A device intended to be used once only for a single patient.

8. MDD 93/42/ECC- Compliance:
• Scope of the Directive 93/42/EEC
• Classification
• Conformity Assessment Route
• Compliance to the Essential Requirements
• Harmonized standards
• Technical File
• Risk assessment
• Notified Body
• Authorized Representative and Competent Authority registration
• Vigilance system
• CE Marking
• Declaration of Conformity
• Adherence to the MDD requirements for conducting self inspection

9. MDD 93/42/EEC shall NOT apply to--
• invitro diagnostic devices;
• active implantable devices covered by Directive 90/385/EEC;
• medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls
under that Directive or this Directive, particular account shall be taken of the principal
mode of action of the product;
• cosmetic products covered by Directive 76/768/EEC (2);
• human blood, blood products, plasma or blood cells of human origin or to devices
which incorporate at the time of placing on the market such blood products, plasma or
cells, with the exception of devices referred to in paragraph 4a;
• transplants or tissues or cells of human origin nor to products incorporating or derived
from tissues or cells of human origin, with the exception of devices referred to in
paragraph 4a;
• transplants or tissues or cells of animal origin, unless a device is manufactured utilizing
animal tissue which is rendered non-viable or non-viable products derived from animal
tissue.

10. Articles
• Article 1 Definitions, scope
• Article 2 Placing on the market and putting into service
• Article 3 Essential requirements
• Article 4 Free movement, devices intended for special purposes
• Article 5 Reference to standards
• Article 6 & Article 7 Committee on Standards andTechnical Regulations
• Article 8 Safeguard clause
• Article 9 Classification
• Article 10 Information on incidents occurring following placing of devices on the market
• Article 11 Conformity assessment procedures
• Article 12 Particular procedure for systems and procedure packs and procedure for sterilization, Article 12a Reprocessing of medical
devices
• Article 13 Decisions with regard to classification and derogation clause
• Article 14 Registration of persons responsible for placing devices on the market; Article 14a European databank ,Article 14b Particular
health monitoring measures
• Article 15 Clinical investigation
• Article 16 Notified bodies
• Article 17 CE marking Article 18Wrongly affixed CE marking

11. Annex:
• Annex I: Essential requirements
a) General requirements
b) Requirements regarding design and construction.
• Annex II: EC Declaration of conformity
• Annex III: EC type examination
• Annex IV:EC verification
• AnnexV,VI,VII: EC Declaration of conformity
• AnnexVIII: Statement concerning devices for special purposes
• Annex IX: Classification criteria
a) Definition for the classification rules
b) Implementing rules
c) Classification
• Annex X: Clinical evaluation
a) General provisions
b) Clinical investigation
• Annex XI: Criteria to be met for the designation of notified bodies
• Annex XII: CE marking of conformity

12. Guidance Document:
 EU Commission INTERPRETATION OFTHE MEDICAL DEVICE DIRECTIVES
IN RELATIONTO MEDICAL DEVICE OWN BRAND LABELLERS
 MEDDEV (Medical Devices Info)
• Manuals (Borderline and Classification Expert Group)
• NB-MED
• GMDVS (EU Commission MEDDEV document regarding
• "Guidelines for Medical DeviceVigilance System“)

13. How device Classification is Determined
• Duration of contact:
< 60 minutes Transient
< 30 days Short term
>30 days Long term
Degree of invasiveness:
Application to body surface or into body orifice
Surgically invasive
Implantable

14. How Classification is Determined:
Degree of invasiveness
Duration of contact
• Transient Class I Low riskThermometers
• Short term Class IIa Medium risk Needles
• Long term Class IIb Medium risk Insulin pens
• Long term Class III High risk Implants
Class I non sterile and non measuring
Class I sterile and measuring

15. Conformity Assessment Routes
Annex II – EC Declaration of Conformity (Full Quality Assurance
System)
• Most comprehensive conformity assessment procedure
• Full quality system including the design phase for new devices or changes of
existing devices;
• EN ISO 13485 or use an equivalent quality system suitable
Class I (Sterile and Measuring), IIa, IIb and III manufacturers can choose to follow
Annex II and implement a full quality system that covers all classes of products.

16. Annex III - ECType Examination:
• Procedure for the product design which involves examination
• Third party testing of representative samples of the device and certification that
the device meets the applicable essential requirements of the MDD;
• ECType Examination is applicable only to class IIb and III devices
Class IIb and III manufacturers can elect to have a Notified Body do an audit using a
representative sample of the company’s production to ascertain compliance with
the directive. Used when Annex II is not the preferred route to compliance. Annex
IV,V orVI must be used in conjunction with Annex III.

17. Annex IV – ECVerification
• Comply applicable requirements as per MDD
• EN ISO 13485
• OtherTechnical Specifications
The Notified Body can sample up to 100% of the products, or may do statistical
batch testing. If batch testing is done and accepted by the Notified Body, all
products in the batch can bear the CE Marking. 20

18. AnnexV - EC Declaration of Conformity
(Production Quality Assurance)
• Excluding the design phase of new devices but including all other aspects of
conformity with the MDD
• Most suitable procedure for sterile class IIa devices
• EN ISO 13485.
This is much the same as Annex II but without design inspection. Often used by
companies that manufacturer Class I sterile/measuring and Class IIa, and those that
do not design their own products.

19. AnnexVI - EC Declaration of Conformity
(Product Quality Assurance)
• Devices whose relevant properties can be assessed in final inspection
• EN ISO 13485
• Not suitable for devices involving special manufacturing processes requiring
validation, like sterilization
• May not be used for the assessment of class III products.

20. AnnexVII - EC Declaration of Conformity
• Manufacturer himself declares the compliance of his devices with the MDD;
• Suitable for class I devices, and required for class IIa devices in combination with
one of the Annexes IV,V, orVI.
• Requires the manufacturer to compile aTechnical File and conduct a risk
assessment.

21. Essential Requirements
• General requirements
• Design & construction requirements
• Chemical, physical and biological properties
• Infection and microbial contamination
• Construction and environmental properties
• Information supplied by the manufacturer on the label and in the instructions for
use

22. Risk Management:
EN ISO 14971:2012 is used to:
• Identify the product and describe the intended use
• Characteristics which could affect safety
• Identify possible hazards
• Estimate the risk, and

23. Notified Body
• Third party organization appointed by a Member State to undertake prescribed
activities
• Commercial contracts with manufacturers
• Certifications

24. Authorized Representative
• Authorized Representative for Europe in the event the manufacturer is not
established within the EEA
• Listed on the label and/or packaging
• Name of the manufacturer and the device must be notified to the Competent
Authority
• Keeps theTechnical File available for review by Competent Authorities
• Plays an essential role in vigilance procedures and Post-market Surveillance

25. Post Marketing Surveillance
• Required for all devices
• Review of market, field data, complaints, investigation, corrective actions
• Systematic records kept
Vigilance, MEDDEV 2.12.1, Rev. 5
The manufacturer must:
• Institute and keep up to date a systematic procedure to review experience gained
from devices in the post- production phase and;
• Implement appropriate means to apply any necessary corrective actions

26. C E Marking
• Implies conformance with all European Directives
• Inspection Authorities
• Preempts all other marks for same requirements
• Not a quality mark!
• Measurement
• Affixing
• Labeling

27. Declaration of Conformity