European CE Marking For Medical Devices

EUROPEAN CE MARKING
FOR MEDICAL DEVICES
www.mavenprofserv.com
OVERVIEW
How is CE marking of medical devices useful for
manufacturers?
Who can apply for European CE marking of medical
devices?
European CE Marking as per EU MDR 2017/745
Regulation
How Maven can help with your European CE marking?
Maven is a regulatory consultancy providing one-stop solution for
the CE marking of your medical devices, providing overall support
with technical documentation, identification of external testing and
coordination with associate laboratory partners, generating UDI’s,
EUDAMED registration, appointment of EC REP (European Authorised
Representative) and coordination with notified body.
How is CE marking of medical devices useful
for manufacturers?
European CE marking is a prestigious mark for any medical
device to have and it assures customers of the product quality,
safety and efficacy.
CE marking a medical device allows access to the entire

European market and offer manufacturer significant business
reach. Along with Europe, there are many other countries that
accept CE marking as a concrete proof of product quality and
country registration process in those countries becomes very
easy and with significantly reduced timelines and scrutiny.
With increased competition it is very important that
manufacturers have competitive advantage over other medical
device manufacturers. Having a CE mark on their medical
device will enhance their reputation and increase customer
confidence on their medical device.
Customers and end-users these days have become aware and

are concerned about what medical device is being used on
them or on their patients and having a CE marked medical
device gives them assurance of device safety.
Who can apply for European CE marking of
medical devices?
Any medical device manufacturer based within or outside the EU
region can apply for CE marking of a medical device(s). For the
manufacturers based in the EU region, it is mandatory to follow the
law of the land and comply with the EU regulation. Manufacturers
based outside the EU region can choose if they are looking to sell in
European countries or many other countries that accept CE marking
and accordingly decide to choose CE marking.
Can I apply for CE marking if I subcontract my manufacturing
activities to an OEM?
If you subcontract manufacturing to an Original Equipment
Manufacturer (OEM), you can always apply for CE marking as a legal
manufacturer.
Can I apply for CE marking if I am a medical device distributor?

Yes, a distributor can apply for CE marking as a legal manufacturer
under the EU Medical Device Regulation (MDR) if they take on the
responsibilities of the legal manufacturer. as stated in article 16 of EU
MDR Cases in which obligations of manufacturers apply to importers,
distributors or other persons
European CE Marking as per EU MDR 2017/745
Regulation
The CE marking process as per EU MDR Regulation is
significantly different than what has been in practice under the
MDD directive. The EU MDR demands for the right approach with
more focus on product safety and efficacy to ensure patient
safety.
The ideal steps to begin any CE marking process are as below:
Check If your device falls under the definition of a medical device

as provided by EU 2017/745 implementing regulation.
If this device qualifies as a medical device the next step would be
to classify the device as per classification rules mentioned in the
EU MDR (Annex). You can also use technical file with relevant
technical, administrative and product related information. Follow
the General Safety and Performance Checklist (GSPR) and
identify applicable standards, MDCG documents and generate the
required evidence.
Check if the risk assessment files and the clinical evaluation of the
product is adequate to demonstrate performance and safety and
shows acceptable level of compliance as per EU regulations.
Internally assess the documents for any gaps and if required
outsource the gap analysis of your documents to Maven to ensure
compliance before submission to the notified body.
For manufacturers based outside of the EU region, it is mandatory
to appoint a European Authorised Representative and retain the
same till the certification validity.
Contact a UDI issuing agency like HIBCC, to assign the basic UDI-
DI for your product category and UDI-DI for your products.
Register your manufacturing organisation on the EUDAMED portal
and obtain manufacturers Single Registration Number (SRN).
Find the appropriate notified body that is eligible to assess your
product type. You can find the same in their list of NANDO codes.
Make the application to them and get the assessment timelines and
audit details. Please note Class I devices that do not have a
measuring function (Class Im), or are not re-usable (Class I) or are
not sterile surgical instruments (Class Is) don’t require notified body
intervention and can carry on with self-declaration of conformity
(DOC).
Affix CE mark on your products (After notified body issues a CE
certificate/after self-declaration for Class I devices.
Continually update relevant technical documents through Post
Market Surveillance data.
An annual surveillance audit takes place every year after the
certification audit to ensure continued compliance till the validity
of the certificate i.e. 5 years.
How Maven can help with your European CE
marking?
Though CE marking can be done by following the above mentioned
steps, what makes the process complicated for manufacturer interpret
is
The appropriate interpretation of the EU MDR regulation. The
Regulation doesn’t have a straight forward conclusion on what is
applicable or required but one has to co-relate different sections
on the regulation to conclude on what requirements are applicable
to their product making it extremely important to have a correct
approach of reading, understanding and concluding the
requirements.
Multiple MDCG guidelines. To understand the requirements of this
vast regulation, the EU commission has released hundreds of
MDCG guidelines that cover information regarding various sections
of the regulation and it can be overwhelming to have a hold of
these guidelines and identify and implement the appropriate ones.
Lack of previous exposure to notified body assessment. Many
manufacturers are new to the CE marking process and may
struggle in understanding the requirements put up by the notified
body and not be able to answer or address their
concerns/questions to the best of their knowledge, leading to
failure even after having systems and processes in place.
Here comes into picture, consultation services like ours that help
manufacturers through all the above mentioned drawbacks and
foster support for preparation of technical documents, performance
of the correct external testing, compiling the technical files as
notified body would like them, answer to notified body concerns and
provide audit support. Our services are customizable and can cater
to the need of medium and small scale manufacturers with and end-
to-end support or provide small customisable services to
multinationals that require support specific to clinical evaluations,
risk assessment or gap analysis.
Contact Us
https://mavenprofserv.com/european-ce-marking-
for-medical-devices/
business@mavenprofserv.com
enquiry@mavenprofserv.com

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EUROPEAN CE MARKING

FOR MEDICAL DEVICES

CE marking a medical device allows access to the entire

Customers and end-users these days have become aware and

Can I apply for CE marking if I am a medical device distributor?

Check If your device falls under the definition of a medical device

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