EU MDR

REGULATORY PERSPECTIVE OF
MEDICAL DEVICE (2017 EU/MD)
BY-ROHIT

INTRODUCTION
 ‘medical device’ means any instrument, apparatus, appliance, 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, treatment or alleviation of
disease,
-Diagnosis, monitoring, treatment, alleviation of, an injury or 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.

CLASSIFICATION RULES
(EU/MDD 2017 ANNEX-VIII/CHAPTER 8)
 DURATION OF USE
Transient continuous use for less than 60 minutes.
Short term continuous use for between 60 minutes and 30 days.
Long term continuous use for more than 30 days.
 Rules for non-invasive MD
 All non-invasive devices are classified as class I, except
 All non-invasive devices intended for channeling blood, body liquids,
cells or tissues, liquids or gases for the purpose of eventual infusion,
administration or introduction into the body are classified as class IIa.
-Except for blood bags; blood bags are classified as class IIb.

CONTINUE…
 All non-invasive devices for modifying the biological or chemical
composition of human tissues or cells, blood, other body liquids or
other liquids intended for implantation or administration into the body
are classified as class IIb except those are for filtration and exchanges of
gas, in which case they are classified as class IIa.
 Class IIa if any device is principally intended to manage the
microenvironment of wound.
-Adhesives for topical use

 All non-invasive devices which come into contact with injured skin or
mucous membrane are
Class I if they are intended to be used as a mechanical barrier, for
compression or for absorption of exudates.
Class IIb if they are intended to be used principally for injuries to skin which
have breached the dermis or mucous membrane and can only heal by
secondary intent.
-If nanoparticle or drug Class III

RULES FOR INVASIVE MD
• All invasive devices except surgically invasive device with respect to body
orifices, other than surgically invasive devices
- Class I if transient use.
- Class IIa if they are intended for short-term and IIb if long term use.
• Surgically invasive devices- class IIa unless,
-Control, diagnose, monitor or correct a defect of the heart through direct
contact with those parts of the body, then they are classified as class III.
-are reusable surgical instruments, in which case they are classified as class I

 Administer medicinal products by means of a delivery system
(Hazardous manner), Class IIb
-have a biological effect or are wholly or mainly absorbed in that case they
are classified as class Iib
 Implantable devices and long-term surgically invasive classified as class
IIb but implanted at outer orifice of body Ex. Teeth implant-Iia
 Implantable devices or their accessories, in which cases they are
classified as class III are breast implants.
 All invasive devices with respect to body orifices, other than surgically
invasive devices, which are intended to administer medicinal products by
inhalation are classified as class IIa

THE MEDICAL DEVICE CLASSIFICATION
(EU MDR 2017/745 ANNEX VIII)
 Class I: Wheelchair, otoscope, stethoscope, scalpel, plaster.
 Class I (Special): It can be the same products as listed on class I but with
special aspect.
 Measuring function-Thermometer
 Delivered Sterile-Bed pans
 Reprocessed to be reused -scalpel
 Class IIa: Syringe which delivers a medicine, Teeth implant, X-Ray Device,
Contact lenses.
 Class IIb: Blood bag, implantable plate, screws and haemodialysis system
 Class III: Drug coated stent, spinal disc cage, breast implants, pacemaker,
Artificial valve, CNS chips.

REGULATORY PROCESS FOR MEDICAL
DEVICES IN EUROPEAN UNION
 Step1- Determine which EU Medical Device Directive applies to the
device for certification: MDR [( 93/42/EEC – Medical Devices
Directive (MDD) or 90/385/EEC - Active Implantable Medical Devices
Directive (AIMDD) or 79/98/EEC IVD)]
 Step 2- Determine classification of device using Annex VIII of the
Medical Devices Directive (MDD): Class I (non-sterile, non-
measuring), Class I (sterile, measuring), Class II a, Class II b or
Class III/AIMD. Active implantable medical devices are typically
subject to the same regulatory requirements as Class III devices.

 Step 3 - For all devices except Class I, implement Quality Management
System (QMS) in accordance with Annex II or V of the MDD. For Class I,
a QMS is not formally required, though not likely to be audited by a
Notified Body (NB).

QMS
The quality management system shall address at least the following
aspects:
 A strategy for regulatory compliance, including compliance with
conformity assessment procedures and procedures for management of
modifications to the devices covered by the system.
 Identification of applicable general safety and performance requirements
 Responsibility of the management;
 Resource management: including selection and control of suppliers and
sub-contractors;
 Risk management as set out in in Section 3 of Annex I.
 Clinical evaluation in accordance with Article 61 and Annex XIV, including
PMCF
 Product realization, including planning, design, development, production
and service provision;

 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;
 Implementation and maintenance of a post-market surveillance
system, in accordance with Article 83
 Handling communication with competent authorities, notified bodies,
other economic operators, customers and/or other stakeholders;
 Processes for reporting of serious incidents and field safety corrective
actions in the context of vigilance.
 Management of corrective and preventive actions and processes for
monitoring and measurement of output, data analysis and product
improvement.

NOTIFIED BODY (NB)
 Right and duty to carry out unannounced on-site audits and to conduct
physical or laboratory tests on devices to ensure continuous compliance
by manufacturers after receipt of the original certification.
 Carry out the conformity assessment activities with the highest degree of
professional integrity and the requisite technical and scientific
competence in the specific fields(Annex IX and XI).
 The proper functioning of notified bodies is crucial for ensuring a high level of
health and safety protection and citizens' confidence in the system.
 The technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the authority responsible for
notified bodies.
 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.

 Step 4 - For Classes II b, prepare a Technical File which provides detailed
information on medical device, and demonstrates compliance with
93/42/EEC. For Class III/AIMD devices.

TECHNICAL DOCUMENTATION
 Device description and specification-
Product or trade name and a general description of the device including its
intended purpose and intended users
 Reference to previous and similar generations of the device
 Labeling and the instructions for use in the languages accepted in the
Member States
 Design and manufacturing information
 General safety and performance requirements-
The method or methods used to demonstrate conformity with each
applicable general safety and performance requirement, precise identity of
the controlled documents offering evidence of conformity with each
harmonized standard,

 Benefit-risk analysis and risk management (sections 1 and 8 of Annex I,)
-the solutions adopted and the results of the risk management
 Product verification and validation
- Results and critical analyses of all verifications and validation tests and/or
studies undertaken to demonstrate conformity of the device
 Pre-clinical and clinical data
- Results of tests, such as engineering, laboratory, simulated use and animal
tests, and evaluation of published literature applicable to the device
- Detailed information regarding test design, complete test or study protocols,
methods of data analysis

o Biocompatibility of the device including the identification of all materials in
direct or indirect contact with the patient or user;
- Physical, chemical and microbiological characterization
 Stability, including shelf life
 The clinical evaluation report and its updates and the clinical evaluation
 Additional information required in specific cases
- Where a device is manufactured utilizing tissues or cells of human or
animal origin
- In the case of devices that are composed of substances or combinations of
substances (PK data for drug device)

 Step 5 – Appoint an European Authorized Representative (EAR Rep)
located in Europe. The AR Rep should be qualified to handle regulatory
issues

AUTHORIZED REPRESENTATIVE
 Manufacturer of a device is not established in a Member State, manufacturer
designates a sole authorized representative
 Task perform by AR are:-
 Confirm the appropriate conformity assessment procedure and immediately
inform the manufacturer about complaints from physician
 Keep available a copy of the technical documentation
 Verify that the manufacturer has complied with the registration obligations
laid down in Articles 27 and 29
 Forward to the manufacturer any request by a competent authority of the
Member State
 Co-operate with the competent authorities on any preventive or corrective
action taken to eliminate or mitigate the risks posed by devices.

 Step 6 – For all devices except Class I, QMS and Technical File must
be audited by a Notified Body.
 Step 7 – 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.

CE (EUROPEAN CONFORMITY) MARKING
 Devices, considered to be in conformity with the requirements of this
Regulation shall bear the CE marking of conformity, as presented in Annex V
(Except custom made device and clinical use or Investigational device)
 The CE marking shall be affixed visibly, legibly and indelibly to the device.
• Check which directives are applicable for device
• Determine the class and choose conformity
assessment procedure
• Prepare technical documentation, implement QMS
• Prepare CER
• Prepare declaration of conformity and submitted to
Notified body for certification
• Apply CE mark and market the product
• Implement post-market surveillance
Emergo Services

Step 8 – Prepare a Declaration of Conformity, a legally binding document
prepared by the manufacturer stating that the device is in compliance with the
applicable Directive.
Step 9 – All Class I devices must be registered with the Competent Authority.
Step 10 – Must perform 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 your CE Marking certificate. CER must perform updates and PMS
activities.

POST-MARKET SURVEILLANCE
 Post-market surveillance’ means all activities carried out by manufacturers in
cooperation with other economic operators to institute and keep up to date a
systematic procedure to proactively collect and review experience gained
from devices they place on the market
 Data gathered by the manufacturer's post-market surveillance:-
-Information concerning serious incidents, including information field safety
corrective actions.
-Records referring to non-serious incidents and data on any undesirable
side-effects and publicly available information about similar medical
devices
-Information from trend reporting
-Information, including feedbacks and complaints, provided by users
distributors and importers

MAJOR CHANGES
 Notified bodies (NB), manufacturers and importers will have to be
registered (MDR certificate)
 Installation of a scrutiny procedure for NBs (Class IIb and III devices)
 Technical documentation (Annex II) must be updated continuously
 Labeling requirements (Sterile Barrier Labeling, Absorbable device, e IFU)
 Clinical investigation
 A Unique Device Identification (UDI) will be required
 The EUDAMED Database will be extended:
-Access to competent authorities, manufacturers, Notified Bodies and the
public and Display of certificates, vigilance reports, clinical investigations,
and PMCFs(Post Market Clinical Follow up) .
https://ec.europa.eu/health/md_eudamed/overview_en

CER CONTENT
•Section A: Administrative particulars (notified body, manufacturer, product
and clinical evaluation report reference)
•Section B: Reviewers involved in the notified body assessment of the clinical
evaluation
•Section C: Device description,
•Section D: Clinical literature review
•Section E: Clinical investigations and related documentation
•Section F: PMS, PMCF and the plan for updates
•Section G: IFU, SSCP, labelling and other information supplied with the device
•Section H: Summary of all available data and conclusions
•Overall Conclusions

1.EC International (Slovakia) – 2265 (MDR
scope)
2.BSI (Netherlands) – 2797 (MDR scope)
3.BSI (UK) – 0086 (MDR scope)
4.CE Certiso (Hungary) – 2409 (MDR
scope)
5.DARE!!! Services (Netherlands) –
1912 (MDR scope)
6.DEKRA Certification (Germany) –
0124 (MDR scope)
7.DEKRA Certification (Netherlands) –
0344 (MDR scope)

GENERAL OBLIGATIONS OF MANUFACTURERS
 Manufacturers shall ensure that they have been designed and manufactured
in accordance with the requirements of this Regulation
 Manufacturers shall establish, document, implement and maintain a system
for risk management as described in Section 3 of Annex I.
 Manufacturers shall conduct a clinical evaluation in accordance with the
requirements set out in Article 61 and Annex XIV
 Keep up to date technical documentation and copies.
 After compliance with the applicable requirements affix the CE marking of
conformity in accordance with Article 20.
 keep up to date and continually improve a quality management system
that shall ensure compliance with this Regulation in the effective manner

CONTINUE.
 Manufacturers of devices shall implement and keep up to date the post-
market surveillance system in accordance with Article 83.
 Manufacturers who consider or have reason to believe that a device which
they have placed on the market or put into service is not in conformity with
this Regulation shall immediately take the necessary corrective action
to bring that device into conformity, to withdraw it or to recall it, as
appropriate.
 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

CERTIFICATES ISSUED BY A NOTIFIED
BODY
 Certificates shall be drawn up in one of the official languages of the
Union.
 The name and address of the manufacturer included in the certificate
shall be the same as that registered in the electronic system
 certificates shall include the identification of the devices or groups of
devices, the risk classification, and, for class IIb devices

CONTENT OF CERTIFICATE
 Name, address and identification number of the notified body;
 Name and address of the manufacture
 Unique number identifying the certificate, if already issued, the SRN of
the manufacturer
 Date of issue and expiry
 Reference to this Regulation and Annex in accordance with which
the conformity assessment has been carried out.
o Conclusions of the notified body's
o Legally binding signature of the notified body

EU MDR

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