2. Introduction
● The Medical Device Regulation(MDR) 2017/745 was published on May 5, 2017,
replacing the two directives Medical Devices Directive (MDD) (93/42/EEC) and
90/385/WG Active Implantable Medical Device Directive (AIMDD).
● Manufacturers of medical devices of class I to class III are required to implement the
changes as per the new MDR 2017/745.
4. Major Differences
No Economic Operators
Such a definition did not exist in the
MDD
UDI
No such centralised labelling
requirements
Technical File
ERC compliance & non code
based classification
PRRC
Definition of EUAR as the
important personnel for
compliance but no PRRC
Economic Operators
Registration with the EUDAMED
UDI
Centralised labelling
requirements
Technical File
GSPR compliance & code based
classification
PRRC
Dedicated personnel for
compliance
MDR
Transition
MDD
compliance
MDR
compliance
5. What’s new in the MDR?
● Includes 123 Articles, 10 chapters, and 17 Annexes
● Reclassification of devices to a Higher Risk Class
● Non-medical and cosmetic devices (lenses, phototherapy devices, etc.) now come
under the regulation
● Implementation of Unique Device Identification (UDI)
● EUDAMED Registration
● In-depth clinical data, technical documentation, and labeling requirements
● Increased requirements for clinical evidence and PMS activities
● MDR 2017/745 is four times longer, and contains five more annexes than MDD
● General Safety and Performance Requirements replaces Essential requirements
● UDI for products of all classes
● Registration of Economic Operators with EUDAMED
6. New MDR 2017/745 Requirements
Classification
Revisit your classification to ensure no change in the classification and corresponding
regulatory requirements. If there is a change consider that in gap assessment
Qualified NB
Review the NBOG codes and have an understanding of the other applicable codes to
wisely select the NB who is eligible for conducting a review
Team and Timeline
Ensure there is a good blend of senior strategy oriented personnel and an execution
focussed team to adhere to the planned timeline
QMS and Tech File
Several implications on the existing QMS and the technical documentation must be
considered and planned for a complete compliance
Clinical requirements
Review the existing clinical data on file and evaluate what else is needed. Know the
SSCP, PSUR, and other pre and post market clinical obligation
First step for transition/ new
certification
A mandatory step for best ROI
A cost and time extensive
requirement
Follow all doc control
practices
Align on expectations
with all stakeholders
8. Timeline for Transition
2012
5th May
2017
25th May
2017
26th May
2020
26th May
2021
MDR proposal
by EU
Commision
EU MDR
published by EU
Commision
EU MDR
comes into
force
Date of
application
End of 3 - Years transitions
with Extension (1 Year
Extension due to Covid)
10. Strategy for MDR Transition
1. Plan
Identify what the transition means for your company and
check the transitions period as per device classification.
1. Do
Check classification as per MDR. Perform gap analysis and
begin preparing the relevant documentation.
1. Check
Check for new requirements and cross verify the requirements
across different guidances such as MDCG guidances.
1. Act
Implement the above steps and schedule the MDR audit.
13. Classification Rules as per the MDR
Per MDR 2017/745 there are 22 Rules as given in Annex VIII.
Classification Rules
Non - Invasive
Devices
Invasive Devices Active Devices Special Rules
Rule 1-4 Rule 5-8 Rule 9- 13 Rule 14-22
Added for Software
Medical Devices (Refer
MDCG 2019- 11)
Guidance on qualification and
classification of Software in
Regulations MDR/IVDR
Rule 11
14. Device Classification as per MDR
Medical devices are classified into following categories:
Class I - Low Risk
Class Is - Sterile
Class Im - Measuring
Class Ir - Reusable Surgical Instruments (newly added)
Class II-Moderate to High Risk
Class IIa - Moderate Risk
Class IIb - Moderate -High Risk
Class III - High Risk
Considering the intended purpose of the device and
their inherent risk.
Note: Software classification is newly added in MDR 2017/745
as per Rule 11.
16. Changes in the Conformity Assessment
● Annex VI (Product Quality Assurance) of MDD is removed in MDR 2017/745.
● Annex IV (EC verification) of MDD, is replaced by Annex XI, Part B in MDR.
● Sampling is not allowed in MDR 2017/745 and hence each and every product is to be
tested.
● Annex V (Product Quality Assurance) of MDD is replaced by Annex XI, Part A in
MDR.
17. Specific Requirements for Class III and Class
IIb Devices
In Article 54 and 55, there are some special requirements discussed regarding clinical
evaluation consultation and specific procedure (scrutiny) for certain Class IIb and Class III
medical devices.
The procedure is applicable for the following devices:
- Implantable Class III devices.
- Active Class IIb devices for administering/removing medicines
18. New Requirements for Declaration of Conformity
● Common Specifications
Common specifications used and in relation to which the conformity is declared should be added in the DoC.
● UDI-DI
The Basic UDI along with the product name, registered trade name, product code, catalogue number, etc. are to be
included in the DoC.
● Single Registration Number
SRN number of the manufacturer, and if applicable, the authorised representative, and registered place of business.
21. Requirements of Economic Operators
ISO 13485:2016, section 4.1.1
The organisation shall document the roles undertaken by the organization under the
applicable regulatory requirements.
NOTE: Roles undertaken by the organization can include manufacturer, authorized
representative, importer, or distributor.
22. Person Responsible for Regulatory Compliance
(PRRC)
Manufacturers shall have at least one person responsible within their organization for regulatory compliance.
Requisite Expertise of PRRC
● a diploma, certificate or other evidence of formal qualification and at least one year of professional
experience in regulatory affairs or in QMS relating to medical devices;
● four years of professional experience in regulatory affairs or in quality management systems relating to
medical devices.
23. Notified Bodies (NBs)
● Designated bodies by EU countries to conduct conformity assessment procedures as per the applicable
Regulations.
● Technical documentation and the manufacturers’ quality management systems are audited by the NBs.
● It is important that the manufacturers choose a suitable Notified body depending on the timeline and
expense involved in the process of certification.
List of certified NBs under MDR - NANDO MDR database.
25. ● It is a summary of the product documentation and all the product related elements put
together in a clear and concise manner.
● Major change in the technical documentation requirements is the GSPR, which
replaces the ERC.
● Comprehensiveness of the Technical Documentation for MDR has increased as
compared to MDD.
Technical Documentation
28. Post-Market Surveillance
● The goal behind the PMS is to introduce a continuous cycle of device improvement.
● PMS documentation consists of a PMS Plan and a Report.
● Manufacturers of Class I devices shall prepare a PMS Report (PMSR) summarizing
the results and conclusions of the analyses of the data gathered.
● Manufacturers of Class IIa, IIb, and Class III devices shall prepare a Periodic
Safety Update Report (PSUR).
29. Update Frequency for PMSR/PSUR
Classification PMSR/PSUR How or When Submitted Frequency of updation
Class 1 PMSR Only Upon request When Necessary
Class IIa PSUR During Notified Body assessment
review/during Audit
Every 2 years
Class IIb (Implantable
devices)
PSUR Through EUDAMED for Notified
body review
Every year
Class IIb (Non
Implantable Devices)
PSUR During Notified Body assessment
review/during Audit
Every year
Class III PSUR Through EUDAMED for Notified
body review
Every year
31. Clinical Evaluation
● Clinical Evaluation shall be conducted based on a methodological procedure.
● Both clinical evaluation and risk management should be inter-dependent and updated
regularly.
● The Clinical Evaluation consists of:
○ Clinical Evaluation Plan
It is the road map for conducting the clinical evaluation process.
○ Clinical Evaluation Report
Clinical evaluation report provides the conclusions of a clinical evaluation of the
medical device.
32. Post-Market Clinical Follow-Up (PMCF)
● A PMCF is a continuous process used to regularly update the clinical evaluation and shall be a
part of the manufacturer’s PMS plan.
● The PMCF file comprises of the following:
○ PMCF Plan
It is an important technical document that outlines a method for conducting Post-Market Clinical
Follow-up on a medical device
○ PMCF Report
It is a structured report that summarises the findings of PMCF activities conducted in relation to
a medical device
Note: The clinical evaluation and its documentation shall be updated throughout the lifetime of
the device with clinical data obtained from PMS and PMCF plans.
33. Summary of Safety and Clinical Performance
(SSCP)
● Shall be drawn up in case of a Class III and implantable devices or other
investigational or custom-made devices.
● It is to be made available via EUDAMED for the public.
● Information in the SSCP is drawn from the Technical Documentation.
● SSCP should be reviewed and updated as and when the PSUR and the PMCF are
updated, which is at least, annually
35. ● The UDI or “Unique Identification Number” is an important part of the new EU
MDR 2017/745 requirements.
● UDI is a requirement for the EUDAMED Database, and IT system developed for
monitoring the safety and performance of medical devices.
● GS1, HIBCC, and ICCBBA are some of the Issuing Agencies that provides UDI.
UDI (Unique Identification Number)
36. UDI (Unique Identification Number)
Sl. No. Requirements Device Class Implementation Year
1 UDI carriers to be placed on all the labels and all
levels of packaging.
All implantable devices, regardless of
class
2021
Class III 2021
Class IIa, IIb 2023
Class I 2025
2 UDI carriers to be placed on reusable devices. All implantable devices, regardless of
class
2023
Class III 2023
Class IIa, IIb 2025
Class I 2027
38. ● EUDAMED stands for European Database for Medical Devices.
● It is a web-based portal that contains the information on national competent
authorities and the European Commission.
● It was created with the purpose of strengthening market surveillance and
transparency.
● Actor registration of the EUDAMED is now open.
● It shall contain information such as Declaration of conformity, vigilance and
traceability systems and a lot more.
EUDAMED
39. QMS Requirements as per MDR - Article 10(9)
As per Article 10 (9), 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.”
● Process for product registration.
● Conformity assessment route based on the classification of the device (CE Mark).
● Notified body selection and management.
● Europe AR responsibilities and authorities.
● Language translation requirements.
● Changes to the product (significant changes) to be notified to the NB.
● Person responsible for Regulatory Compliance (PRRC), his/her qualifications and appointment for the same.
