EU - MDR

7 March 2019|COMPLIANCE, EU-MDR, MDR, GTS

Introduction to EU-MDR
Before BREXIT European union comprises of 28 countries and the EU Economic
Corridor also counts Iceland, Liechtenstein and Norway and through bilateral
treaties, Switzerland and Turkey. It is the largest single market with a wealthy, aging
population of over 500 million consumers.
European Union and EU Common Economic Corridor was also created for the free
movement of goods which is one of the cornerstones of this treaty.
Once a new product enters in any member country, by default the product will be
circulated in all the member states of EU. The 2016 version of the Blue Guide on the
implementation of EU products lists three conditions that must be met for goods to
move freely

1. Essential requirements for the products involved must be defined.

2. Methods must be established to describe how product compliance with the

requirements is addressed.

3. Mechanisms to supervise and control the actions of all Economic Operators

and others involved in the manufacturing and distribution of the products must
be created

The IVDR and the predecessor IVDD of the Medical Devices Regulation (MDR) (EU)
2017/745 – the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC,
and the Medical Devices Directive (MDD) 93/42/EEC - do just that.
These directives defined Essential Requirements and introduced harmonized
standards, helping to demonstrate conformity to the Essential Requirements. The
directives also defined conformity assessment procedures and organized market
surveillance functions by Competent Authorities (CAs) and Notified Bodies (NBs).
These directives, introduced in early 1992, have worked well and helped create the
single market for medical devices in Europe.
However, the directives had some inherent weaknesses and the changes in
technology and medical science demanded changes in legislation. These
shortcomings challenged national member states and the interpretation of the
directives was not consistent across all national governments. The IVDR and the
predecessor IVDD Directive 2007/47/EC modified the MDD and AIMDD in an
attempt to address these concerns but this amendment did not achieve all goals.

Main Themes of the Regulation

Compared to the MDD, the MDR promotes a shift from the pre-approval stage (i.e.,
the path to CE Marking) to a life-cycle approach. This approach is similar to the life-
cycle view advocated by the US Food and Drug Administration (FDA) and advanced
by many international standards. The life-cycle approach is illustrated by the
incorporation of European guidance (MEDDEVs) into the regulation. Guidance on
authorized representation, clinical evaluation, vigilance, and post-market clinical
follow-up have been integrated into the MDR.
As the MEDDEVs are not legally binding, this change reduces the flexibility in
interpretation by industry as well as the authorities and NBs. The current MEDDEVs
do not apply to the MDR, although many elements from the MEDDEVs have been
incorporated in the Regulations. The Regulations do not rule out the use of guidance
documents by the authorities. It is likely, although not formally confirmed, that the
European Commission would support guidance documents being published through
the vehicle of MDCG Working Groups. The compliance of all devices with Essential
Requirements has to be reassessed, with reference made to current standards and
state of the art. This means there will be no grandfathering.
However, devices with valid certificates issued under the current directives can still
be placed on the market until May 2024, provided no significant change in design or
intended purpose is made. According to the current document, NBs would be placed
under a strict regimen of supervision, although it remains unclear whether intended
sanctions against an NB that violates MDR requirements could be implemented
against the will of a member state.
The qualification requirements for auditing and reviewing NB staff have steeply
increased. Much greater emphasis will be placed on clinical data and clinical
evaluations. Equivalence, currently commonly used to justify references to studies
done with other devices, will be more rigorously interpreted. This will be a far more
challenging way to demonstrate clinical safety or performance for medical devices.

What is the European Medical

Device Regulation - in Short...

The European Medical Device Regulation (EU MDR) ensures high standards of
quality and safety for medical devices being produced in or supplied into Europe. It is
to have a fundamental revision in 2017 to better identify medical devices products
and improve transparency through standard data, technological advances and the
establishment of an EU database (Eudamed). Similar to the FDA’s UDI, EU MDR will
establish a robust, transparent, predictable and sustainable regulatory framework for
medical devices to ensure a high level of health and safety whilst supporting
innovation.

EU MDR is relevant to any organization producing or supplying medical device

products to Europe.

ITS BENEFITS

Until now, different European countries have interpreted and implemented the
directive in different ways. By revising the directive EU MDR will enforce:
- Stricter pre-market control of high-risk devices at an EU level
- The inclusion of certain aesthetic products which present the same characteristics
and risk profile as equivalent medical devices
- A new risk classification system for diagnostic medical devices based on
international guidance
- Improved transparency through the establishment of a comprehensive EU
database of medical devices (EuDaMed)
- Device traceability through the supply chain from its manufacturer through to the
final user
- An EU-wide requirement for an 'implant card' to be provided to patients containing
information about implanted medical devices
- the reinforcement of the rules on clinical data and clinical studies on devices
- Manufacturers to collect data about the real-life use of their devices
- Improved coordination between EU Member States

EU Member states and Geography

EU Countries List
EU MDR’s IMPACT ON LABELING:

The new EU MDR/IVDR regulation puts labeling in a prominent position. It is critical

for regulatory, labeling and operational professionals to gain a clear understanding of
the impact of the new regulations on labeling.

1) What are the most important MDR implementation and compliance

deadlines for manufacturers?
This is a complex question. For Class I medical devices there is a hard deadline at
the date of application, expected in May or June 2020, but early compliance is
allowed. Higher-risk devices may only switch to MDR certification once their Notified
Bodies (NBs) have been designated for the MDR. This is not expected to happen
before the end of 2018. “Old” Medical Device Directive (MDD) certificates may be
used until they expire. One can continue to use the current MDD certificates,
provided they have not expired, for four years after the date of application (May or
June 2024).

2) Will unexpired CE Mark certificates be accepted during/after MDR

implementation?

Yes. Unless suspended or withdrawn, all MDD certificates will remain valid until they
expire, or until four years after the date of application (May or June 2024), whichever
comes first. Certificates issued under MDD Annex IV or Active Implantable Medical
Device Directive (AIMDD) Annex 4, however, will remain valid until they expire or two
years after the date of application (May or June 2022), whichever comes first. There
are some conditions for using this "grace period;" no significant changes are allowed,
the device needs to remain compliant with the current MDD, and new MDR vigilance
and post-market surveillance requirements must be applied.

3) Will the MDR change how we oversee our critical suppliers?

The MDR includes provisions for unannounced audits, although so did the MDD.
However, now, NBs must perform unannounced audits at least once every five
years. Critical suppliers should be integrated into manufacturers’ quality systems.
This also means that any risks related to the production of a device must be
identified and mitigated; an example of this is organizing a second, back-up source
for a critical component of your device.

4) How will the MDR affect European market authorization for Class I non-
sterile/non-measuring devices/non reusable instruments?

Whereas manufacturers of such devices must currently notify relevant Competent

Authorities, they will be required under the MDR to enter data about their devices
into the Eudamed database themselves. Such manufacturers will also have to set up
quality management systems, although registrar certification of these quality systems
will not be required. Clinical data requirements will also increase under the MDR.

5) What will the MDR mean for own-brand labeling (OBL) of some devices?

Every manufacturer must have access to full technical documentation according to

the MDR. This would require that OBL manufacturers hand over those files, which
may not be easily done. It is expected that in practice this requirement will put an
end to OBL manufacturing as we know it under the MDD.

6) Will there be more stringent NB requirements for clinical evaluation reports

(CERs) under the MDR?

Yes, MEDDEV 2.7/1 Rev. 4 is a big step in the direction of the MDR requirements in
this area. However, MDR goes further: Clinical evaluation is a permanent process
that must be covered by plans and reports. NBs will assess plans, procedures and
results documented in CERs and other evidence.

7) How will the MDR change Post Market Clinical Follow-up (PMCF)
requirements?

The PMCF is a “continuous process to update the clinical evaluation (Annex XIV,
Part B).” This process will mainly drive the clinical performance evaluation, and must
be based on real-life data. The results must be taken into account for clinical
evaluation and risk management.
8) Does the MDR introduce or specify any Unique Device Identification (UDI)
rules for the European market?

Each device will have to be assigned a UDI. A manufacturer must obtain a UDI code
from a UDI supplier, upload device-specific data into Eudamed and then link the UDI
to that data set. After that, the UDI must be placed on the device label before
distribution can occur.
9) Are there any changes MDR brings in terms of device equivalency
requirements?
Equivalent devices need to be equivalent with respect to technical, biological and
clinical properties to such extent that it can be demonstrated that there is no clinically
relevant difference (this has not changed from MEDDEV 2.7/1). The manufacturer
must also be able to demonstrate equivalence by having access to equivalent device
data, and the MDR even requires a contract between the manufacturer and the
equivalent device manufacturer to access the technical documentation of that
device. This will in practice mean that equivalence can only be claimed to devices for
which a manufacturer has access to technical documentation. So, this will in practice
limit the use of equivalence to devices in the same families, or to equal devices in
other generations.

10) This looks like a lot of work. Where do I start?

Indeed, this IS a lot of work and you should contact Pinnacle Software Technologies
Limited at the earliest. The first step is to make a transition plan for each of your
devices and for your organization as a whole.
Your Pharmaceutical, Medical Device manufacturing company can be EU-MDR
compliant with your existing SAP ERP and SAP GTS systems – HOW? Contact us
at https://pinnaclesoftwaretechnologies.com/contact-us