MDR Capabilities

By Team Elexes jennifer@elexes.com

 What we will cover in this call?
What is MDR?
Key highlights of MDR
Our history with MDR projects
Other services related to MDR
What is MDR?
"Medical Device Regulation" (MDR) refers to
a set of regulations and rules set by the
European Union governing the manufacture,
distribution, and sale of medical devices in
the European Union (EU). The specific
regulation being referred to is the European
Union Medical Device Regulation (EU MDR),
which came into effect on May 26, 2021,
replacing the previous EU Medical Device
Directive (MDD).
 The New 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

Registration of Economic Operators with EUDAMED
General Safety and Performance Requirements replaces Essential Requirements
MDR 2017/745 is four times longer and contains five more annexes than MDD
 MDD v/s MDR

2
1 3
Moderate Changes
Major Changes Classification rules Minor Changes
Requirements of
Unique Device Stakeholders in the
Clinical evaluation,
Identification System lifecycle of the medical
clinical investigation,
Classes of medical device
and post-marker
devices Person responsible for
surveillance system
regulatory compliance
 Details of the EU MDR Transition
Extension
On 15 March 2023, the European Union extended the EU MDR transition periods 26 May
2024 to

26 May 2026 for class III implantable custom-made devices

31 December 2027 for class III and implantable class IIb devices
31 December 2028 for non-implantable class IIb and lower-risk devices
31 December 2028 for class I devices that are a higher class under the MDR
 Details of the EU MDR Transition
Extension
The EU also removed its 12-month “sell-off” provision so non-transitioning medical
devices that comply with the EU MDD may now be supplied in the EU, after May 2025,
until the stock is depleted.
MDD-notified bodies will not re-issue MDD certificates with extended expiry dates.
Rather, the EU MDR unilaterally extends the validity of current MDD certificates if
certain criteria are met.
To qualify for the EU MDR transition extension, manufacturers must:

Apply for MDR certification with an MDR-notified body by 26 May 2024 and
before their MDD certificate expires, and
Have a contract in place with an MDR-notified body before 26 September 2024.
 Expanded Scope Risk-Based Classification
Key The EU MDR broadens the scope of
medical devices to include a wider
The regulation introduces a more detailed
and comprehensive risk classification

Highlights range of products.

It also includes some products that

system for medical devices. This
classification system determines the level of
scrutiny and conformity assessment
were previously not explicitly regulated procedures required for each device.
as medical devices.

Unique Device
Identification (UDI)
The EU MDR mandates the use of a UDI system to
enhance the traceability of medical devices
throughout their lifecycle. This includes the
assignment of a unique identifier to each device
and its packaging.
Clinical Evaluation and
Clinical Investigations
Stricter requirements are imposed on
clinical evaluation and clinical
investigations. Manufacturers must
provide more comprehensive clinical
data to demonstrate the safety and
performance of their devices.
Increased Post-Market
Surveillance
The regulation places greater emphasis
on post-market surveillance, including
the need for continuous monitoring of
devices in the market, reporting of
adverse events, and the submission of
periodic safety update reports (PSURs).
Key Notified Bodies
Notified bodies, which are responsible
Transparency and
Information Sharing

Highlights for assessing the conformity of The EU MDR promotes transparency by

medical devices, face stricter
requirements for designation and
oversight. They play a critical role in
the certification process.
providing patients, healthcare professionals,
and regulatory authorities with more
comprehensive information about medical
devices. This includes requirements for
labeling and public access to certain data.

EUDAMED Database
Clinical Evidence and
The European Database on Medical Devices
(EUDAMED) was established to collect and share Performance Studies
information on medical devices, including
Manufacturers are required to conduct
registration data, clinical investigation results,
performance studies for certain devices
and adverse event reports.
and provide more extensive clinical
evidence to support their claims of
safety and effectiveness.
Economic Operator
Responsibilities
The roles and responsibilities of
economic operators in the medical
device supply chain (manufacturers,
authorized representatives, importers,
distributors) are clearly defined, and
they face increased obligations.
Penalties and
Enforcement
The regulation includes provisions for penalties
and measures to address non-compliance with
the EU MDR, aiming to ensure stricter
enforcement.
Case Study 1
Navigating the EU MDR Transition

Our client, a leading manufacturer of Portable skin cancer detection

devices, wanted to transition from EU Medical Device Directive (MDD)
to EU Medical Device Regulation (MDR).

Objective
Ensure compliance with EU MDR before the deadline
Seamlessly transition existing products to meet MDR requirements
Revamp technical documentation and Quality Management
System (QMS) as per EU MDR requirements
Case Study 1
Solution
Our team offered end-to-end assistance, providing the following solutions:

Conducted a comprehensive gap

analysis to identify areas of non-
compliance
Assisted in updating and aligning technical documentation and
QMS processes with EU MDR requirements. This includes:
Collaborated closely with the client
to develop a tailored compliance
Updating Product documentation
roadmap
Performing standard gap assessment and see if any testing
required
Provided training to client staff on Updating QMS procedures and records as per EU MDR
MDR-related changes requirements
Ensuring the client has appointed PRRC and EU representative
Performing Internal Audits against EU Updating PMS-related records, such as PSUR, PMCF Plan
MDR requirements and EN ISO 13485 Revising Clinical Evaluation Report
Assisting during Management
Review Meeting

Assisted during External Audit with

the Notified Body (TUV SUD)
Case Study 1
Results

Achieved EU MDR compliance ahead of the deadline

Streamlined technical documentation, ensuring adherence to MDR standards
Enhanced the client's QMS elements for greater efficiency and compliance with EU MDR
Minimized disruption to the client's production and distribution

Key Takeaways

Thorough preparation and proactive planning are essential for a smooth transition
Collaboration and clear communication between teams is critical
Compliance with EU MDR leads to enhanced product safety and quality
Case Study 2
EU MDR Compliance Training Success Story
Our client, a prominent medical device
manufacturer, faced the daunting challenge of
understanding and implementing the complex
requirements of the EU Medical Device Regulation
(MDR).

Objective
Equip the client's team with awareness of EU MDR requirements on
the following:

Post-market surveillance (PMS) processes

Adverse Event Reporting
QMS requirements

Train on the assessment of changes in accordance with EU MDR.

Case Study 2
Solution
Our team provided a tailored training program covering all aspects of EU MDR
requirements:

Implementation

Conducted customized training sessions for the client's staff, addressing

PMS, Adverse Event Reporting, Economic Operators, QMS requirements, and
Change Assessment.
Offered practical examples to
reinforce learning.
Delivered ongoing support and consultation to answer questions and
provide guidance during implementation.
Case Study 2
Results

The client's team gained a deep understanding of EU MDR requirements, fostering

compliance confidence

Clear roles and responsibilities of Economic Operators were defined and integrated into
the client's operations

Key Takeaways

Comprehensive training is pivotal to EU MDR compliance

Practical exercises and ongoing support solidifying knowledge and
implementation
 Devices we have worked with
S.No Device Category MDD or MDR?

1 Catheter MDR

Wireless Wheelchair head controller and

2 MDR
head mouse

3 Therapeutic laser device MDD. MDR (WIP)

Therapeutic device for the primary Axillary

hyperhidrosis (excessive underarm
4 MDR
sweating) in adults using microwave
energy

5 Hemodialysis System MDR

6 Skin cancer detection non-invasive device MDR

7 EKG monitor MDR

8 AI-based Breast Screening MDD

 Other services relevant to MDR
Gap Analysis for MDR Compliance
Support during EUDAMED Registration for legacy devices

Interacting with NBs to obtain quotes and schedule audits (DQS)

Draft of following in line with EU MDR requirements -

Technical Documentation Training on the following:

GSPR
PMS Plan Responsibilities of economic operators
PMCF Plan EU MDR General requirements
CER PMS requirements
Labels Adverse event report requirements
eIFU requirements Change assessment
QMS procedures
Notified Bodies we’ve worked with
Thank You