Starting in early 2020, medical devices seeking CE Marking certification in Europe must comply with the new Medical Device Regulation (MDR). This will require appointing personnel responsible for regulatory compliance, classifying the device, appointing an Authorized Representative located in the EU, including labeling with this information, and obtaining a Single Registration Number. Manufacturers must also prepare technical documentation, implement a quality management system, and undergo annual audits by a Notified Body to maintain certification.

1. Europe
© 2016 Emergo – Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 11/2016. EmergoGroup.com/europe
Starting in early 2020, medical devices must comply with the Medical Device Regulation (MDR)
in order to obtain CE Marking certification.
Appoint a “Person Responsible” for regulatory compliance.
Determine classification of your device using Annex VII (Classification Criteria) of the MDR.
Appoint an Authorized Representative (EC REP) located in the EU who is qualified to handle regulatory issues.
Place your EC REP name and address on device label. Obtain a Single Registration Number from EUDAMED.
Prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating
that the device is in compliance with the MDR. You may now affix the CE Marking.
Register the device and its Unique Device Identifier (UDI) in the EUDAMED database. UDI must be on label.
In accordance with Annex II, prepare a CE Technical File or Design Dossier (Class III*) providing
information about your device and its intended use plus testing reports, Clinical Evaluation Report (CER),
risk management plan, IFU, labeling and more. Obtain a Unique Device Identifier (UDI) for your device.
You will be audited by a Notified Body each year to ensure ongoing compliance with the MDR.
Failure to pass the audit will invalidate your CE Marking certificate. Your must perform Clinical Evaluation,
PMS and PMCF activities to maintain certification.
Implement a Quality Management System (QMS) in accordance with Annex VIII of the MDR.
Most companies apply the EN ISO 13485 standard to achieve compliance. Your QMS must include
Clinical Evaluation, Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) plans.
Make arrangements with suppliers about unannounced Notified Body audits.
You will be issued a CE Marking certificate for your device and an ISO 13485 certificate for your facility
following successful completion of your Notified Body audit. ISO 13485 certification must be renewed
every year. CE Marking certificates are typically valid for 3 years, but are reviewed during your annual
ISO 13485 surveillance audit.
Your QMS and Technical File or Design Dossier must be audited by a Notified Body, a third party
accredited by a European Competent Authority to audit quality management systems and products.
Prepare CE
Technical File with CER
according to Annex II.
CE certificates do
not expire. Clinical
evaluation must be
kept updated.
Class I
Self-certified
Class IIa
Class I
Sterile, measuring
or reusable surgical
Class IIb Class III
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The Regulatory Process for Medical Devices
MDR Process
Effective early 2020
* All devices require will require clinical data. Most of these data should refer to the subject device. Clinical studies are required for Class IIb and III implants. Existing clinical data may be acceptable. Clinical trials in
Europe must be pre-approved by a European Competent Authority.
This is a simplified overview of the process. Your Notified Body may choose to audit your submission and request more documents, which will add time to your approval.
Implement QMS but
Annex VIII compliance
not required.
No Notified Body audit
of QMS or Technical File.

2. Europe
Notes
1. The MDR was not released until mid-2016. Emergo expects there will be far more demand for recertification services between now and 2020 than
the existing pool of Notified Bodies can handle. We expect this will lead to significantly longer review times than the 3-9 month approval timelines
experienced under the MDD. Your length of approval will also depend on the quality and completeness of your technical documentation, more specifically
your clinical data, and how much time you take to address additional information requests from authorities after submission.
2. CE Marking certificates are typically valid for a maximum of 5 years, but are generally reviewed annually at the same time as the ISO 13485 surveillance
audit. They remain valid as long as you do not make changes to the device, intended use or indications for use and you perform adequate clinical evaluation
activities, including PMS and PMCF. Failure to pass your annual audit could invalidate your CE Marking certificate.
3. Most CE Marking certificates are valid for a maximum of 5 years, and you do not need to “re-register” your device in Europe. However, your Notified
Body will conduct an annual compliance audit and could invalidate your device CE certificate if you are found to be out of compliance. Your Notified
Body will reissue your CE certificate every five years. Annual and renewal audits require careful planning. We recommend starting the preparations for
your annual audit no later than the time specified above. Please consult with your regulatory expert well before this suggested time to avoid any lapse
in your registration.
4. Our rating of the complexity of the registration process is based on our extensive experience and the opinion of 1,000 QA/RA professionals worldwide
who were asked to rate the difficulty of registering a device in each country.
5. Prices in US Dollars for a single device. 1 = Less than $5,000; 2 = $10,000 - $15,000; 3 = $15,000 - $30,000; 4 = $30,000 - $50,000; 5 = $50,000 or more.
Estimated cost includes registration application fees, in-country representation, Notified Body audit fees, submission preparation consulting and
translation of documents, as required. It is important to note that these estimates are based on the existing process under the Medical Devices Directive
(93/42/EEC). As more stringent requirements are put into place with the MDR, we expect overall CE compliance costs to rise. This remains to be seen so
please only use these number for very rough planning purposes. Costs assume you already have approval for your device in the United States, Canada,
Australia or Japan. Cost do NOT include product testing, clinical trials, or ISO 13485 implementation, if applicable. These costs are generally shared across
many markets and thus not specifically attributed to a European CE submission.
EmergoGroup.com/europe
Device classification
in Europe
Class I
Self-certified
Class I
Sterile, measuring
or reusable surgical
Class IIa Class IIb Class III
How long you should
expect to wait after
submission until
approval is granted.1
See note 1* See note 1 See note 1 See note 1 See note 1
Validity period for CE
Marking certificate.2 Does not expire 5 years 5 years 5 years 5 years
Registration renewal
should be started this
far in advance.3
Not applicible 6 months 6 months 6 months 6 months
Complexity of the
registration process
for this classification.4
Estimated cost
(USD) of gaining
regulatory approval .5
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© 2016 Emergo – Have comments or suggestions about the content of this table? Email us at marketing@emergogroup.com. Table updated 11/2016.
Time, Cost, and Complexity of Registration
Simple Complex
Low High
Simple Complex
Low High
Simple Complex
Low High
Simple Complex
Low High
Simple Complex
Low High
Class I devices which are not provided sterile, do not have a measuring function or are reusable surgical instruments can be self-certified (self-declared). Entering the required data into EUDAMED will be
sufficient to allow placement on the market in Europe. However, this can only be done if the manufacturer has obtained a Single Registration Number to identify the company, and a UDI to identify the device.
Currently the timelines for implementation of these databases is unknown.
This is a simplified overview of the process. Your Notified Body may choose to audit your submission and request more documents, which will add time to your approval.
*
5
55
1 2
2
3
3
4
4
MDR Process
Effective early 2020