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The EU’s Medical

Device Regulation
Staying up-to-date
with the new requirements

The EU’s medical device regulation The expected changes and their impact
Medical device manufacturers seeking market access The MDR differs in several important ways from the
to the European Union (EU) will soon face major changes EU’s current directives for medical devices and active
in the EU’s decades-old regulatory framework. The EU’s implantable medical devices. Changes in the regulation
Medical Device Regulation (MDR) was officially published include expansion of the scope of products covered, more
on 5 May 2017 and came into force on 25 May 2017. rigorous requirements for clinical evaluation including
The MDR will replace the EU’s current Medical Device changes to clinical investigations, mandatory unique device
Directive (93/42/EEC) and the EU’s Directive on active identification (UDI) mechanisms, and increased post-market
implantable medical devices (90/385/EEC). oversight by EU Notified Bodies.

Background Specific details on these and other changes, along with

The origins of the MDR date back to 2008, when the their anticipated impact include:
EU Commission initiated a public consultation on the
Community’s existing requirements covering medical Product scope expansion – The definition of medical
devices. This consultation produced more than 200 devices and active implantable medical devices
comments and proposals for change from a wide variety covered under the MDR is expected to be significantly
of stakeholders. As a result, the Commission released expanded to include devices that may not have a
in 2012 its plan to restructure the EU’s medical device medical intended purpose, such as coloured contact
regulatory framework, along with a regulation that would lenses and cosmetic implant devices and materials.
replace existing directives for medical devices and active Also for inclusion within the scope of the regulation
implantable medical devices. are devices designed for the purpose of “prediction” of
a disease or other health condition.

TÜV SÜD
 Reclassification of devices according to risk, is expected to be expanded to provide more efficient
contact duration and invasiveness – The MDR will access to information on approved medical devices.
require device manufacturers to review the updated
classification rules and update their technical Rigorous post-market oversight – The MDR will grant
documentation accordingly by considering the fact Notified Bodies increased post-market surveillance
that class III and implantable devices will have higher authority. Unannounced audits, along with product
clinical requirements and a regular scrutiny process. sample checks and product testing will strengthen
It is expected that device manufacturers will also be the EU’s enforcement regime and help to reduce risks
required to collect and retain post-market clinical data from unsafe devices. Annual safety and performance
as part of the ongoing assessment of potential safety reporting by device manufacturers will also be
risks. These changes will result in a dramatic increase required in many cases.
in the time and resources needed by manufacturers
to conduct the required studies and to maintain S
 pecifications – The MDR will give the EU Commission
post-market documentation. or expert panels the authority to publish Common
Specifications. These Common Specifications would
More rigorous clinical evidence for class III and exist in parallel to the Harmonised Standards and will
implantable medical devices – Manufacturers will be seen as State of the Art, and would be considered
need to conduct clinical investigations in case they as part of the evaluation process by Notified Bodies.
do not have sufficient clinical evidence to support
the claims done on both safety and performance of a No “grandfathering” provisions – Under the MDR,
dedicated device. all currently approved devices must be recertified
in accordance with the new requirements.
Systematic clinical evaluation of Class IIa and Class Manufacturers with currently approved devices will
IIb medical devices – Manufacturers will need to have three years to demonstrate compliance with
re-prepare their clinical evaluations by considering the the MDR’s new requirements. Exemptions are under
new wording of the regulation on when an equivalence negotiation right now.
approach and under which circumstances it is possible
to justify not conducting a clinical investigation.

Identification of “qualified person” – Device

manufacturers will be required to identify at least one
person within their organisation who is ultimately
responsible for all aspects of compliance with the
requirements of the new MDR. The organisation must
document the specific qualifications of this individual
relative to the required tasks. Further, qualifications
of responsible persons will be subject to review by
Notified Bodies to ensure requisite knowledge and skill.

Implementation of unique device identification –

The MDR mandates the use of unique device
identification (UDI) mechanisms. This requirement
is expected to increase the ability of manufacturers
and authorities to trace specific devices through the
supply chain, and to facilitate the prompt and efficient
recall of medical devices that have been found to
present a safety risk. To support this effort, the
European Databank on Medical Devices (Eudamed)
The MDR timeline TÜV SÜD is the world’s largest EU Notified Body for
The MDR was officially published on 5 May 2017 and all types of medical devices covered by EU directives
came into force on 25 May 2017. Manufacturers of and regulations. We are also a leading global
currently approved medical devices will have a transition management certification body for quality management
time of three years until 26 May 2020 to meet the systems, including management systems applicable
requirements of the MDR. in the manufacture of medical devices. This unique
combination of experience makes TÜV SÜD ideally suited
It is important to note that, as an EU regulation, the MDR to address the needs of medical device manufacturers
will have the force of law throughout the EU after the seeking to achieve or maintain compliance with medical
date of application. This approach will eliminate country- device requirements in the EU and other major markets
by-country interpretations of the requirements permitted around the world.
under current directives, and is also likely to speed up
the actual effective date of the MDR’s requirements Why choose TÜV SÜD?
across the EU. TÜV SÜD offers a complete range of testing, auditing
and certification services to manufacturers of medical
How you can prepare? devices, helping them to manage risks and to protect and
The complex development process for medical devices, promote the health and safety of patients. Our global
combined with the changes, are likely to make the network of more than 500 dedicated medical health
transition a complicated and time consuming process for services professionals include scientists and physicians
most device manufacturers. recognised as authorities in their respective fields.
These capabilities make TÜV SÜD the preferred single
Because of these complexities, medical device source for worldwide compliance with medical device
manufacturers are well-advised to stay current on the regulations.
progress of the MDR through the regulatory approval
process, as well as additional changes that may impact Choose certainty. Add value.
them. In addition, since a large number of medical TÜV SÜD is a premium quality, safety and sustainability
devices are expected to require Notified Body review company that specialises in testing, inspection, auditing
and approval, delays in the review and approval process and certifications. Represented in over 1000 locations
by Notified Body should be expected. Manufacturers worldwide, we hold accreditations in Europe, the
of currently approved devices are therefore advised to Americas, the Middle East, Asia and Africa. By delivering
evaluate potential compliance issues and to develop a services to our customers, we add tangible value to
plan to address them promptly. Advanced preparation businesses, consumers and the environment.
and early action will be key to ensuring a smooth
transition to the new requirements. Related services

How we can help? TÜV SÜD provides the following related services:
TÜV SÜD is closely following developments related Global approval of medical devices (foreign
to the MDR, and will regularly provide updated affairs)
information to our clients through various resources ISO 9001 – Quality management system
such as webinars, whitepapers, information factsheets certification
etc. These and other resources are designed to help ISO 13485 – Quality management system
medical device manufacturers stay fully informed about certification for medical devices
the anticipated changes, and to provide assistance in Medical device market assessment and
achieving compliance with the new requirements. certification
Medical device testing
What is a medical device? the person himself or a third party deputizing for this
A medical device means any instrument, apparatus, person. Manufacturers outside of the EU require, in
appliance, software, implant, reagent, material or other addition, a representative within the EU.
article intended by the manufacturer to be used, alone
or in combination, for human beings for one or more Classification of medical devices by their
defined specific medical purposes. risk potential
Annex VIII of the directive stipulates the classification
Who is a manufacturer? of the devices according to its risk potential, in
The directive defines a manufacturer as a natural classes I (low), IIa, IIb and III (high). Depending on
or legal person who is responsible for the design, the classification of the product, the conformity
manufacture, packaging and labeling of a medical assessment procedures apply. The directive includes
device with regards to marketing in his own name, 22 classification rules covering duration of use, level of
regardless of whether these actions are performed by invasiveness, location of use and energy supply.

Conformity assessment diagram

Annex I: Essential Safety and Performance Requirements

All other Explanation
custom-
made Annex IX, Chapter I:
Annex II and III: Technical Documentation Quality Management System,
audit by Notified Body
Implantable
III, Class III Annex IX, Chapter II:
implantable IIb IIa, IIb I* III, IIb I custom-made Assessment of the Technical
Documentation by Notified Body

Annex IX, Section 6,

specific procedures
Annex IX Annex IX Annex IX Annex X Annex IX Annex XIII
Type Examination Chapter I Procedure Annex X, Section 6,
Chapter I Chapter I Chapter I Audit of for specific procedures
Audit of Audit of Audit of If applicable: the quality custom- Annex X:
the quality the quality the quality X (6) management made EC type testing
management management management system devices
system system system Annex XI, Part A:
EC certificate Production Quality Assurance
+ + Limited
to the Annex XI, Part B:
Chapter II Chapter II aspects of: Product Verification
Assessment Assessment Class I*:
of the of the - Sterility Class I devices that are sterile or
Technical Technical - Measuring do have a measuring function or
Documentation Documentation, function Annex XI Annex XI are surgical reusable instruments
sample basis - Reusability Part A Part B
+ Implantable Class IIb:
+ Production Product Some implantable Class IIb
If applicable: Quality Verification devices are exempted from this
Paragraph 5.x If applicable: Assurance (every rule
Paragraph 5.x device)
Assessment of Technical
Documentation for Class IIa or
EC certificate EC certificate EC certificate EC certificate EC certificate EC certificate Class IIb according to Annex IX
or Annex XI:

- Sample base Class IIa:

Device category
DoC DoC DoC DoC Statement - Sample base for Class IIb:
Generic device group

Scrutiny for implantable Class III and active

2017 © TÜV SÜD AG | V-M/MHS/19.1/en/SG

Class IIb devices for administering/removing

medicinal products from/to the body only

TÜV SÜD AG Westendstr. 199, 80686 Munich, Germany

+49 89 5791-0 [email protected] www.tuv-sud.com/medicaldevice