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Medical Device Regulations:
European Union


• Medical devices are products or equipment intended generally for a medical use and

are regulated at Member State level.

• The Medical Devices Regulation (Regulation (EU) 2017/745) applies since 26 May
2021, following a four-year transition period.

• The EMA is body of the European Union whose responsibility is to protect human
and animal health through the evaluation and supervision of medical products for
human or animal use

• Medical devices in the EU have to undergo a conformity assessment to demonstrate
that they meet legal requirements to ensure they are safe and perform as intended.

• EU Member States can designate accredited notified bodies to conduct conformity
assessments. 2


• The conformity assessment usually involves an audit of the manufacturer’s quality
system and, depending on the type of device, a review of technical documentation

from the manufacturer on the safety and performance of the device.
• To market a medical device in Eu it should have a CE mark.

• Manufacturers can place a CE (Conformité Européenne) mark on a medical device
once it has passed a conformity assessment.

• Manufacturers of drugs and medical devices who want to sell their product to a
country in the EU only submit one single marketing authorization application to
the EMA.

• The documentation shall be written in English, French or German. 3


Medical Device (EU):
means any instrument, apparatus, appliance, software, implant, reagent, material
or other article intended by the manufacturer to be used, alone or in combination,
for human beings for one or more of the following specific medical purposes:
✓diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation

of disease, disability
✓investigation, replacement or modification of the anatomy or of a physiological or

pathological process or state,
✓providing information by means of in vitro examination of specimens derived

from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological,
immunological or metabolic means, in or on the human body, but which may be
assisted in its function by such means.
products specifically intended for the cleaning, disinfection or sterilization of
devices. 4


• In the European Union classification is almost similar to that of the US FDA system

• The classification is in accordance with the rules specified in the annexure IX of medical
device directive

• Criteria of classification : Duration of contact, Invasiveness of contact, Active principle
of device

Class Description Examples

I Devices are those with minimal risk of Wheelchairs, Simple Wound dressings,
harm Stethoscopes, ECG electrodes, syringes.

IIa Devices are those with relatively low Contact lenses, ECG machines, Electronic
risk to humans BP monitors.

IIb Devices pose a relatively high risk of Bare Metal Stents (BMS), External
harm to the human body Defibrillator, Urethral stents.

III Devices are deemed the highest risk Joint replacements Drug-Eluting Stents (DES)
of harm to patients and endanger the Pacemakers, Spinal needles
patient’s life or involve electricity to
function 5


Class Sub class Risk Example Detail

I. Reusable surgical This group covers
Nonsterile Low instrument, non-sterile low-risk devices,

gloves and the conformity
procedures are
carried out by

Sterile, Low Sterile dressings (non-
With A medicated), Sterile
Measuring gloves, Volumetric urine
Function bag 6


The intervention of a
II. IIa Medium Ventilators,

orthopaedic Notified body is

implants, compulsory at the

radiotherapy production stage


IIb Higher Inspection by a
Notified body is

III. Highest Prosthetic joints, This group covers the
coronary stent most critical devices

which explicit
authorization with
regard to conformity
is required before
commercialization 7


Regulatory Approval Process
Determine which EU Medical Device Directive applies to the device for

93/42/EEC – Medical Devices Directive (MDD) or 90/385/EEC – Active Implantable

Medical Devices Directive (AIMDD)

Determine classification of device
Active implantable medical devices are typically subject to the same regulatory

requirements as Class III devices. 8


Implement Quality Management System (QMS) in accordance with Annex II or V of the

For Class I, a QMS is not formally required.

For Classes I, IIa, IIb, prepare a Technical File which provides detailed information on
medical device, and demonstrates compliance with 93/42/EEC.

For Class III/AIMD devices, prepare a Design Dossier. 9


Appoint an Authorized Representative (EC Rep) located in Europe. The EC Rep should
be qualified to handle regulatory issues.

Place EC REP name and address on Instructions for Use or outer packaging or device

For all devices except Class I, QMS and Technical File or Design Dossier must be
audited by a Notified Body, a third party accredited by European authorities to audit

medical device companies and products.

For all devices except Class I, manufacturer will be issued a European CE Marking
Certificate for device and an ISO 13485 certificate for facility following successful

completion of Notified Body audit. 10


ISO13485 certification must be renewed every year. CE Marking certificates are typically
valid for 3 years.

Prepare a Declaration of Conformity, a legally binding document prepared by the
manufacturer stating that the device is in compliance with the applicable Directive.

Manufacturers may now affix the CE Marking.

All Class I devices must be registered with the Competent Authority where EC REP is

Some EU member states require additional registration of Class IIa, IIb or III devices
which are placed on their markets. 11


For Class I, CE Certificates do not expire. CER (clinical evaluation report) updates
must be performed and PMS activities.

For all other classes, manufacturer will be audited each year by a Notified Body to
ensure on-going compliance with 93/42/EEC or 90/385/EEC.

Failure to pass the audit will invalidate the CE Marking certificate. 12


Medical Device Directives
The Medical Device Directive is intended to harmonise the laws relating to medical
devices within the European Union. The MD Directive is a ‘New Approach’ Directive for a
manufacturer to legally place a medical device in the European market.
Eg of MDD:- Orthopedic implants, heart valves, medical software.

MDD 93/42/EEC shall NOT apply to
• Invitro diagnostic devices – Directives 98/79/EC 27 October 1998

• Active implantable devices – Directive 90/385/EEC 26 May 2021

• Medicinal products – Directive 2001/83/EC November 2001

• Cosmetic products – Directive 76/768/EEC 27 September 1976

• Transplants or tissues or cells of human origin

• Transplants or tissues or cells of animal origin


Active Medical Device

It means any medical device relying for its functioning on a source
of electrical energy or any source of power other than that
directly generated by the human body or gravity.

Active Implantable Medical Device

It means any active medical device which is intended to be totally
or partially introduced, surgically or medically, into the human
body or by medical intervention into a natural orifice , for
diagnostic or therapeutic purpose and which is intended to
remain after the procedure. 14


Active Implantable Medical Devices (AIMD)
Directives 90/385/EEC

• Since 25 May 2017, new regulations have applied to medical devices and active implantable
devices marketed in the EU. The new EU Medical Device Regulation, (MDR (EU) 2017/745) will
replace the EU directives on active implantable medical devices (90/385/EEC) after May 2021.

About AIMD

• AIMDs include devices as :- pacemakers, defibrillators, infusion pumps, ventricular assist systems
and devices, cochlear implants and neurostimulators.

• As AIMDs are designed to remain in direct contact with the body for extended periods, they are
subjected to rigorous standards and requirements to protect the health and safety of patients. 15


Regulatory requirement for AIMD

• Directive 90/385/EEC of the European Union (EU) specifies the essential requirements
manufacturers and importers must meet to apply the CE Mark and legally market or sell AIMDs in
the EU.

• To demonstrate compliance with the requirements of the AIMD Directive, a manufacturer must

➢ Technical documentation in order to properly evaluate their device.

➢ Quality management system that complies with the Directive’s requirements.

Quality system

The manufacturer shall make an application for evaluation of his quality system to a notified body.

The application shall include:

1. All the appropriate items of information for the category of products manufactured.

2. The quality-system documentation.

3. An undertaking to fulfil the obligations arising from the quality system as approved.

4. An undertaking to maintain the approved quality system in such a way that it remains adequate
and efficacious. 16


What is In Vitro Diagnosis Medical Device

It means 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
1. Concerning a physiological or pathological state, or
2. Concerning a congenital abnormality, or to determine the safety and

compatibility with potential recipients,
3. To monitor therapeutic measures

Intended for Diagnosis, Screening, Monitoring, prediction,
determination 17


Examples of in vitro diagnostic medical devices are:
• Hepatitis or HIV tests
• Clinical chemistry
• Coagulation test systems
• Urine test strips
• Pregnancy tests
• Blood sugar monitoring
systems for diabetics 18


In Vitro Diagnostic Medical Devices (IVDD)
Directive 98/79/EC

• In vitro diagnostic medical devices (IVDDs) are subject to the European Directive

98/79/EC (IVDD). A subgroup of medical products, their market access, use, and

market surveillance is regulated. The IVDD is implemented in the national laws of

the member states. 19


CE Certification
What is CE Marking

CE marking is the medical device manufacturer’s claim
that a product meets the essential requirements of all
relevant European Medical Device Directives. The
Directives outline the safety and performance
requirements for medical devices in the European Union

Manufacturers play a crucial role in ensuring that products placed on the extended
single market of the European Economic Area (EEA) are safe. They are responsible for
checking that their products meet EU safety, health, and environmental protection
requirements. It is the manufacturer’s responsibility to carry out the conformity
assessment, set up the technical file, issue the EU declaration of conformity, and affix
the CE marking to a product. Only then can this product be traded on the EEA market. 20


Agencies involved in CE marking process

❖Manufacturers Competent Authorities are
entities enforcing Medical Device

❖Competent Authorities Directives at the national level in
each EU member state.

❖Notified Bodies
❖Authorized Representatives

Notified Bodies are authorized to
audit manufacturers’ quality
systems and test/review devices
for compliance with applicable EU
Directives and standards. 21


6 steps to affix a CE marking, manufacturer should follow

1 Identify the applicable directive(s) and harmonized standards.

2 Verify product specific requirements.

3 Identify whether an independent conformity assessment (by a notified body) is

4 Test the product and check its conformity.

5 Draw up and keep available the required technical documentation.

Affix the CE marking and draw up the EU Declaration of

Conformity. 22


➢ UDI:
• Unique Device Identification system (‘UDI system’) allow the

identification and facilitate the traceability of devices
• Comprises of-
a) UDI device identifier (‘UDI-DI’)- specific to manufacturer and a

b) UDI production identifier (‘UDI-PI’)- unit of device production and if

applicable the packaged devices 23