EU MEDICAL DEVICE REGULATION (MDR)

For Internal Use Only

FREQUENTLY ASKED QUESTIONS

What is MDR?
The European Union Medical Device Regulation, EU-MDR 2017/745, or MDR,
is a new set of regulations that governs the production and distribution of
medical devices in Europe, including medical gloves and masks. Compliance
with the regulation is mandatory for companies that want to sell medical
devices in the European marketplace. The MDR replaces the previous
European Council Directive 93/42/EEC, or MDD.

Why is the MDR being introduced?

The European Council introduced the MDR for several reasons. One is a wish
to restore confidence in the regulatory oversight system following several
scandals involving companies that marketed unsafe medical devices under
the MDD. The Council also wanted to create a single approach to medical
device regulation that would be common across all EU member states, rather
than continue to allow for differences in interpretation and application
across Europe. Finally, the Council wanted to keep pace with scientific and
technological developments such as modern software or devices that collect
health data. The new MDR will ensure high standards of quality and safety
for medical devices being produced in or supplied to Europe. It will do this
by establishing a robust, transparent, predictable and sustainable regulatory
framework that supports innovation while ensuring better protection of public
health and patient safety.

How is the MDR different than the MDD?

While the old MDD was a “directive” that served as a manual for medical
device manufacturers who wanted to get a CE marking, the MDR is a
“regulation” that more broadly aims to enhance safety for people across
Europe. It introduces new responsibilities for economic operators across
the medical device supply chain and requires each to verify that a previous
operator is compliant. The MDR also introduces new requirements in areas
such as clinical evaluation, post-market surveillance, and labelling, as well
as new systems that make tracing medical devices easier. As a regulation, the
MDR is legally binding and enforced across all member states with less room
for differences in interpretation or enforcement.
What devices are covered by the MDR?
The MDR defines “medical device” as any instrument, apparatus, appliance, software, implant, reagent, material or other
article intended by the manufacturer to be used, alone or in combination, for human beings. A full definition can be found
in Article 2(1) of the MDR. It is worth noting that a product need not be designed for medical use to be considered a medical
device. For example, non-corrective contact lenses, equipment for liposuction and equipment intended for brain stimulation
are all considered medical devices according to the definition in the MDR.

Who are the economic operators in the medical device supply chain?
The economic operators in the medical device supply chain are defined in the MDR as follows:

Manufacturer Importer
A natural or legal person who manufactures or Any natural or legal person established
fully refurbishes a device or has a device designed, within the Union that places a device from
manufactured or fully refurbished, and markets that a third country on the EU market.
device under its name or trademark.

Authorised Representative Distributor

Any natural or legal person established within the EU Any natural or legal person in the supply
who has received and accepted a written mandate from chain, other than the manufacturer
a manufacturer, located outside the EU, to act on the or the importer, that makes a device
manufacturer’s behalf in relation to specified tasks with available on the market, up until the
regard to the latter’s MDR obligation. point of putting into service.

What are the responsibilities under MDR for each operator in the supply chain?
The MDR elevates the responsibilities of each economic operator in the supply chain, and requires they verify that previous
operators have properly complied with relevant MDR requirements. Some examples of important responsibilities for each
economic operator are marked in teal in the below table. Those that are new responsibilities for an economic operator are
noted by the word “NEW”.

Authorised
Responsibility Manufacturer Importer Distributor
Representative

EUDAMED Registration NEW NEW NEW

Product Compliance NEW NEW

Conformity after Handling, Storage & Distribution NEW NEW

Management of Nonconformities NEW NEW

Vigilance Reporting, Including Recalls NEW NEW

Correct Labelling / Unique Device Identification NEW NEW NEW

Complaint Management NEW NEW

Post Market Surveillance NEW

Person Responsible for Regulatory Compliance NEW NEW

Sufficient Financial Coverage in Case of Liability NEW NEW

How will MDR ensure devices can be traced across their IMPORTANT MDR DATES
lifecycle, throughout the supply chain?
Under the MDR, all medical devices will be required to have a Unique
Device Identification label (UDI). This information must be visible on EU MEDICAL DEVICE
either the product itself, or the product package or label. The UDI is REGULATION (MDR)
intended to improve the traceability of medical devices throughout
the supply chain by connecting all the information about each medical
device through a digital information repository called EUDAMED. MDR
requires that a UDI label be directly attached to a medical device or to 2017
its packaging.

When will the MDR go into effect?

The final MDR document was published in May 2017, and the regulations
will come into force in May 2021. During the transition period, devices 2018
may be placed on the market under either AIMDD/MDD or EU MDR.
Medical device companies can receive compliance certification from
Notified Bodies up to the effective date of May 26, 2021, and these
certificates will remain valid for five years from the date of issuance, March 2019
allowing for a smooth transition period. Devices that are legally placed 2019 Transition to ISO 13485:2016
must be completed
on the market before the effective date of May 26, 2021 can be sold until
five years after the MDR takes effect – May 27, 2025.

How will the MDR impact medical glove and mask

manufacturers like Ansell? 2020
Once the new MDR goes into effect in May of 2021, all previous
“directives” will no longer exist or be applicable. All medical glove
and face mask manufacturers must be able to prove they have a
quality management system and technical documentation to show May 2021
the products meet the General Safety and Performance Requirements 2021 MDR date of application

and therefore comply with MDR by May 2021 if they intend to sell
gloves and face masks in the European Union. Ansell already has
a certified quality management system and all technical files have
been updated, ensuring we are fully compliant with this requirement. March 2022
MDR also requires that glove and mask manufacturers follow certain 2022 EC certificates of conformity issued
before May 27, 2017 expire.
new requirements with regards to document storage, post-market
surveillance, and risk assessments of new and existing medical gloves,
as well as a Person Responsible for Regulatory Compliance.

Have the language requirements for labels and 2023

instructions changed compared to the current MDD?
Yes. The MDD’s passive Article 4 (4) which states that “Member States
may require…” the information accompanying the device in national
language(s), has been replaced by the EU MDR’s active Article 10
(11) which states “Manufacturers shall ensure…” the information
2024
accompanying the device is in national language(s). Furthermore, the
new EU MDR Annex I (23.1) also requires the information accompanying
the device to be made available via the manufacturer’s website.
March 2025
Devices certified under the
2025 MDD can no longer be sold
or distributed.
How do I know what Economic Operator I am considered to be under the new MDR?
Ansell can help you understand which Economic Operator you are. One tool we have developed to simplify this process is our
decision tree below. Ask yourself each question and follow the flow chart to see which economic operator you are based on a
few key questions.

Am I buying the medical device for

my own use?

YES NO
You are a User

Am I buying medical devices that are marked with

my own brand/ company name/ private label mentioned

YES NO

Is only my brand/ company name/ Am I modifying the product (including packaging, documents)
private label mentioned? without agreement of the manufacturer or is the change/
modification not foreseen in the Technical Documentation
of the Manufacturer?
YES NO

YES NO
Is the Manufacturer based in the EU

You are a
MANUFACTURER Is the Manufacturer based in the EU
YES NO
You are a
MANUFACTURER
YES NO

You are a You are an

DISTRIBUTOR IMPORTER Am I buying from an Economic
Operator (Importer/ Distributor)
inside the EU? You are a
DISTRIBUTOR

YES NO

You are a You are an

DISTRIBUTOR IMPORTER

Are you an Importer or an Authorised Representative?

Is the Manufacturer based in the EU

YES NO

Do you have an agreement with the Manufacturer to Represent them in the EU

You are a
DISTRIBUTOR
NO YES

You are an You are an

IMPORTER EU Authorised Rep*

*An EU Authorised Representative will have a separate agreement with the Manufacturer to represent them and deal with any enquires from any Competent
Authorities. They still can be an Importer and Distributor and will also need to comply with the obligations set out for them.
How will the new MDR impact me as an importer I have my own private label gloves / masks.
or distributor of medical gloves and masks? How will MDR impact me?
Under MDR, there are new requirements related to post-market Under the previous MDD requirements, many small, private
importation and distribution activities of medical devices in the label manufacturers were not required to have technical
European market. MDR states that each economic operator in documentation available in their facilities, so long as it was
the medical supply chain must verify that a previous economic available at the OEM manufacturer. Under the new MDR,
operator has complied with the MDR requirements. Thus, however, all private label manufacturers will be known as
importers and distributors must ensure independently that, prior “Virtual Manufacturers” and therefore will have the same
to placing a medical device on the market, the manufacturer, responsibilities as stipulated for actual device manufacturers.
importer and the device itself meet the stipulated regulatory This means they must have a full quality management system,
requirements. The device label must include the importer’s ensure devices are fully compliant with proper labels and UDI,
name and address and must be registered in EUDAMED. handle complaints, conduct post market surveillance, and
As a manufacturer, Ansell will be fully compliant with MDR manage many other responsibilities previously required only
requirements by May 2021. of the actual product manufacturer. Under the MDR, virtual
manufacturers risk being non-compliant if they do not have
a Person Responsible for Regulatory Compliance and other
required systems in place.

Is my fulfillment partner now considered to be a

distributor?
Under the MDD, fulfillment partners had few regulatory
responsibilities. Under MDR, these same fulfillment partners
may now be considered distributors if they do anything
beyond clearance, sorting and delivery of medical gloves,
masks and other devices. This means that if they perform
tasks such as storing gloves, packaging gloves, relabeling
gloves packages, or handling customer returns, they will
likely be considered a distributor and therefore must have a
quality management system and meet the obligations of a
distributor as stipulated by the MDR. They must be compliant
with the MDR as of May 2021.
What happens if Companies are not Compliant MDD over to the MDR. While the process is taking place, we will
still be able to place product onto the Market under our existing
to the MDR?
MDD CE Certificate until it expires - as stated in the MDR. There
Competent Authorities will be conducting Marketing will be no disruption in supplying our customers with surgical
Surveillance activities where they will be looking at products gloves.
to confirm that devices on the market are compliant to the
MDR. If found not to be the possible penalties include market Ansell customers are always guaranteed to receive gloves and
recalls, cancellation of CE certificates, bans of all goods in masks that are fully compliant with all applicable EU laws and
the EU supplied by the manufacturer, distributor or importer, regulations – including MDR.
or prosecution – which could carry unlimited fines and even
imprisonment. Remember, under the new MDR, all Economic Can Ansell help me ensure my business in
Operators have a legal responsibility to ensure the devices
compliant with MDR?
they manage are compliant with MDR and safe.
Yes. Ansell is eager to help its customers ensure compliance
Will Ansell be compliant with MDR? with new MDR. If your company is unable to manage MDR
requirements regarding quality management, complaint or
Ansell Healthcare Europe has been working to ensure financial coverage in the event of liability, let us help.
compliance with the new MDR for several years and will be fully
compliant with MDR as of May 2021 for all Class I Products. We have global regulatory expertise, an enhanced quality
We are well prepared to supply our customers and distributor management system and product requirements in place, the
partners with any technical information or documentation they ability to manage the complexities associated with MDR and
may need as they prepare to meet MDR transition deadlines. a strong financial position as a global leader in healthy and
safety solutions. Contact our Director of Regulatory Affairs,
For surgical gloves, our Notified Body, BSI Netherlands, has Samantha Marshall, at [email protected] to
been designated as a MDR Notified Body. We will be working discuss how we can put our expertise to work for you.
with them to transition our existing CE Certificates under the

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