CE-Certification of Medical
Devices under the MDR/IVDREuropean Market Access Medical Devices
Prior to launching a product on the European market it must comply with all applicable requirements in European legislation.
The CE (Conformité Européene) marking is the manufacturer’s declaration that a product fulfills relevant regulations andstandards, including safety, health and environmental protection requirements. All medical devices marketed within theborders of the European Economic Area must fulfil the requirements set out in the In-Vitro Diagnostics or Medical DeviceRegulation (MDR/IVDR), proving safety and performance, in order to affix the CE mark.
DEKRA Certification B.V. (DEKRA) is a Notified Body which is designated in Europe for the MDR(2017/745) and IVDR(2017/746). DEKRA is also an ISO 13485 accredited Certification Body and an MDSAP recognized Auditing Organisation.

MDR/IVDR Pre-application

MDR/IVDR Application

Should you be interested in having devices certified underthe MDR/IVDR by DEKRA, a pre-application is first required.
The following documents should be submitted for the preapplication:> A completed Company Information Form (CIF)> A copy of any relevant certificate(s)> Brochure material, instructions for use, photographs,animations, and any other relevant (device)
Information

After acceptance of the quotation by a manufacturer theMDR/IVDR application process can start. A DEKRA
Project Manager will be assigned and a MedicalApplication Form will need to be completed by themanufacturer. This must be provided to DEKRA, alongwith any other supporting documentation. The DEKRA
Project Manager starts with the formal application review,
after which the Certification Agreement is established.

Based on a review of the above documents, DEKRA willdetermine whether it is accredited and able to provide therequested certification services. Please note that theTechnical Documentation, QMS documents and related
correspondence can only be accepted by DEKRA inEnglish.

At the end of the application phase the TD review activities
and audit activities will be planned.

Once it has been determined that DEKRA can offer therequired services, a quotation will be compiled andprovided.

Please note that this document is for information purposes only and that no warranties are given for its completeness and/or accuracy.

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MDR/IVDR Technical Documentation Review and On-Site Initial Audit
Once the manufacturer has submitted the Technical Dossier, DEKRA shall perform a quick scan on completeness of the file. When approved,
the technical file review will start at an agreed date. After the review DEKRA shall deliver the first report containing, if applicable, a list ofquestions and findings.

The on-site audit will result in a report in which non-conformities, if applicable, are identified. The manufacturer provides a corrective action
plan to address non-conformities identified during the on-site audit and submits evidence of correction of the findings. Finally, when both thetechnical documentation review and audit have satisfactory results, the relevant certificates under the MDR/IVDR can be issued for CEcertification of the identified device(s).
Please note, that the relevant certificates under the MDR/IVDR must be issued within 12 month of the audit taking place. If technicaldocumentation review and/or the audit have no satisfactory results by then an additional, initial audit will be required.

Summary of the steps towards CE certification of Medical Devices under MDR and IVDR
Guiding you through the certification process: from (pre-) application at DEKRA Certification B.V. to CE Mark certificate being issued.

1. Pre-application process
Obtain a quotation for certification> Submit Company Information Form and accompanying documents> Response from DEKRA following pre-application review of the provided
information> Indication of costs and timelines provided by DEKRA (quotation)
Required documents in this phase:• A completed Company Information Form (CIF)• A copy of any relevant certificate(s)• Brochure material, instructions for use, photographs, animations, and otherrelevant (device) information

2. Application process
You have accepted the quotation of DEKRA> Submit Medical Application Form with supporting documents> Assignment of a Project Manager by DEKRA> Application review by DEKRA of the provided form and related documents> Establishment of a Certification Agreement between DEKRA and themanufacturer> Scheduling of technical documentation* review and Audit activities* technical documentation can only by accepted by DEKRA in English

3. Review and Audit activities
Start and planning of the review and audits> Submit technical documentation*> Off-site review of technical documentation by DEKRA> On-site audit at the manufacturer> On-site audit at critical suppliers (if deemed necessary)* Once the manufacturer has submitted the Technical Dossier, DEKRA shallperform a quick scan on completeness of the file. When approved the technicalfile review will start at an agreed date. After the review DEKRA delivers the firstreport containing, if applicable, a list of questions and findings

4. Certification
When the review and the audits have satisfactory results (device and QMS areverified to be in compliance with the MDR 2017/745 or IVDR 2017/746requirements) the relevant certificates under the MDR or IVDR can be issued> Verification of compliance by DEKRA Certification Management> Issuance of certificates under the MDR or IVDR

Please note that this document is for information purposes only and that no warranties are given for its completeness and/or accuracy. 2108:10

Validity of Your CE certificate

Unannounced Audit

After receiving the relevant MDR/IVDR certificate, all
documentation and processes relating to product safetyand performance must be maintained by themanufacturer. In principle, the certificates will be valid forfive years after initial issuance by DEKRA, after whichtime the certificates must be renewed.

DEKRA performs unannounced audits atmanufacturer’s premises which hold a CE certificate inaccordance with the European regulations. Following
a risk evaluation of the CE-marked product lines,
DEKRA may conduct unannounced audit(s) at themanufacturer’s premises and/or critical production,
subcontractor or supplier locations as listed on theDEKRA Certification Notice.

Surveillance Audit
Once the MDR/IVDR certificates have been issued, thesurveillance phase will commence and DEKRA will visit thelocation(s) of the manufacturer on an annual basis. The
purpose of surveillance audits is to confirm that the CEcertified medical devices and the related quality processes
continue to fulfil all regulatory requirements.

Renewal Audit
At the completion of the certification cycle, the DEKRA
Project Manager will generate a plan to begin another fiveyear certification period. The renewal audit is typicallyscheduled to occur three months before the certificate
expiration date. During the renewal process, theeffectiveness of the entire quality management system
within the context of internal and external changes will be
reviewed and audited with respect to its continued relevanceand applicability to the scope of the certification. In case atechnical documentation assessment certificate or a typeexamination certificate has been previously issued, DEKRA
expects the client to lodge a formal Renewal Application in atimely manner; at least 6 months prior to expiry of thecertificate(s).

Subcontractor Audit
Depending on the type of activities outsourced by themanufacturer, additional time may be allocated forsubcontractor audits. Whether an (additional) audit at a
subcontractor’s premises is deemed necessary depends
on the type and extent of control the manufacturer has
over the subcontractor’s activities. Therefore it is importantthat DEKRA is informed about all involved (critical)
subcontractors and suppliers.

Vigilance
In line with regulations to increase the effectiveness ofpost market surveillance, an on-going assessment of allreportable incidents, field safety corrective actions(FSCAs), field safety notices (FSNs) and recalls isrequired by the Notified Body. Therefore, in accordancewith the Certification Agreement and DEKRA General
Terms and Conditions, it is required that the manufacturer
notify DEKRA, along with the relevant regulatory
authorities, of all reportable incidents, FSCAs, FSNs andrecalls related to medical devices covered by thecertification.

Change notifications
Once certified, the manufacturer is obliged to notify DEKRA
of changes to a certified device(s) and quality management
system according to MDR 2017/745 or IVDR 2017/746.
This includes changes to:>
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Approved quality management system(s) or product-range
covered;Approved design of device;
Intended use and claims made for the device;
Approved type of device;
Any substances incorporated in or utilized for manufacturingof a device;
Changes that could impact compliance with the GSPR or CS
or other solutions which were approved previously;
Legal, commercial, organizational status or ownership;
Organization and management (e.g. key managerial,decision-making or technical staff);
Contact address and sites;
Scope of operations under the certified management system;
Major changes to the management system and processes.

Please note that this document is for information purposes only and that no warranties are given for its completeness and/or accuracy. 2108:10

DEKRA Certification B.V.
European Office / HQBusiness Line Medical,
P.O. Box 5185,
6802 ED Arnhem

DEKRA Certification UK LTD,
Stokenchurch House,
Oxford Road,
Stokenchurch,
Buckinghamshire, HP14 3SX

DEKRA Certification Inc. USA,
1945 The Exchange SE #300
Atlanta, GA 30339

THE NETHERLANDS

UKUSA

Tel: +31 88 96 83005
Fax: +31 88 96 83100

Tel: +44 3309 120368

Tel: +1 925 283 7535

medical.global@dekra.com

medical.global@dekra.com

medical.global@dekra.com

DEKRA Certification Japan,
Westwing 1-28-10,
Akebono-cho, Tachikawa-shi,
TOKYO 190-0012

DEKRA Testing and Certification(Shanghai) Ltd., Guangzhou Branch,
DEKRA House No. 3,
Qiyun Road, Science City,
Guangzhou 510663

DEKRA Certification Ltd. Israel
PO box 771, ShohamJAPANP.R. CHINAISRAEL

Tel: +81 42 595 7326
Fax: +81 42 595 8997

Tel. +86 20 66612000
Fax: +86 20 66612001

Tel: +972 9 772 6664
Tel: +972 54 5406006

medical.global@dekra.com

medical.global@dekra.com

medical.global@dekra.com

Please note that this document is for information purposes only and that no warranties are given for its completeness and/or accuracy.
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