CE Marking for Medical Devices under Regulation (EU) 2017/745
BUREAU VERITAS IS LEADING NOTIFIED BODY (1370) FOR THE CONFORMITY ASSESSMENT AND CERTIFICATION OF MEDICAL DEVICES UNDER REGULATION (EU) 2017/745
Through our dedicated team in Switzerland, Swiss manufacturers benefit from local contact, multilingual communication and a structured certification process from application to post-certification surveillance.
CE Marking and Access to the EU Market under Regulation (EU) 2017/745
Notified Body involvement is required for Class IIa, IIb and III medical devices, as well as for specific aspects of Class I devices supplied sterile, Class I devices with a measuring function and Class I reusable surgical instruments.
Bureau Veritas, Notified Body 1370, performs MDR conformity assessment activities within the scope of its designation. Through our Swiss-based team, manufacturers can discuss the application process, required submission information, resource availability and certification timelines.
Early preparation and complete application information contribute to a more predictable and efficient conformity assessment process.
What are the key requirements of Regulation (EU) 2017/745 (MDR)?
Regulation (EU) 2017/745 establishes a strengthened regulatory framework for medical devices throughout their lifecycle. It introduces more detailed requirements for technical documentation, clinical evidence, device classification, Quality Management Systems, traceability and post-market surveillance.
Bureau Veritas Medical Device Certification
Our MDR designation covers a broad range of medical devices and conformity assessment procedures:
Active Medical Devices; Medical Device Software; Non-active Medical Devices; Sterile devices; Devices with a measuring function; Reusable surgical instruments; Substance-based devices; Annex XVI products.
What does the MDR certification journey involve?
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1. Pre-application phase
The manufacturer provides information about the company, device, classification, sites and requested conformity assessment procedure.
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Application review and quotation
We verify whether the application falls within our MDR designation and whether the required resources are available.
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3. Contract and certification planning
The applicable conformity assessment activities, assessment team, estimated timelines and fees are defined.
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4. QMS and technical documentation assessment
Depending on the selected conformity assessment route, the process may include QMS auditing and technical documentation assessment.
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5. Certification decision
Following successful completion of all applicable assessment activities, an independent certification decision is made.
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6. Surveillance and post-certification activities
Certification is maintained through the applicable surveillance activities, including audits and technical documentation surveillance.
Structured Dialogue with bureau veritas
At Bureau Veritas Switzerland, we recognize the importance of clearly defining expectations and regulatory requirements to improve the efficiency and predictability of the conformity assessment process.
Contact us if you are ready to begin the CE Marking journey for your product.
Following your request, we will contact you to arrange a meeting and provide general regulatory guidance on the following topics:
- Timelines for conformity assessment until certification
- Clarification on the data /documentation to be provided
with the application - Qualification and Classification of a product
- Best practice guidance for technical documentation (TD), including preferred structure of TD
- Options of conformity assessment procedures
- Information on all necessary conformity assessment activities – e.g., initial audit, (annual) surveillance audits ,technical documentation assessments, assessment of changes / change notifications
- Pricing and fees
- Applicable standards and guidance documents
- Requirements for sampling of devices for technical documentation assessments
For swiss market
A dedicated Swiss-based team for Swiss medical device manufacturers ensuring availability and delivery with reliable deadlines at all stages, from pre to post-certification.
Our local presence, combined with global expertise, positions us uniquely to support your certification needs efficiently and effectively.
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What are the advantages for Swiss manufacturers?
Local point of contact
Work with a team based in Switzerland that understands the needs and operating environment of Swiss medical device manufacturers.
Available MDR certification capacity
Receive an early indication of resource availability and expected project timelines following application review.
Structured communication
Clarify application requirements, submission format, certification steps, fees and expected timelines before the assessment begins.
Multilingual interaction
Communicate with our team in English, German, French or Italian, depending on project needs and resource availability.
Expertise in medical technologies
Access qualified personnel covering a broad range of medical device technologies within the scope of the Notified Body’s designation.
Global network, local coordination
Combine local coordination in Switzerland with Bureau Veritas’ international certification infrastructure.
Bureau Veritas has established a dedicated development line for the healthcare sector within its matrix structure, boasting specific expertise and in-depth knowledge and experience. This makes Bureau Veritas an exclusive partner for CE Marking and ISO 13485 Certifications, providing clients with the experience of an International Group with a widespread presence in 140 countries.
FAQ - Frequently Asked Questions about Regulation (EU) 2017/745
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Can I transfer my MDR certification to Bureau Veritas?
Yes. You can transfer your MDR certification to Bureau Veritas, including eligible legacy devices benefiting from the extended MDR transition period. We have implemented a streamlined transfer process designed to ensure a smooth transition while requiring minimal effort from the manufacturer. Contact us for a free Structured Dialogue to explore your transfer options and define the next steps.
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Which conformity assessment route applies to my medical device?
The applicable conformity assessment route depends on the device classification, intended purpose and specific characteristics. Bureau Veritas can clarify the available routes and the applicable assessment process during a free Structured Dialogue.
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What documentation is required for an MDR conformity assessment?
The documentation required depends on the device classification and the selected conformity assessment route. It generally includes the Quality Management System documentation and the technical documentation required under Annexes II and III of the MDR, including evidence on risk management, clinical evaluation, verification and validation, usability, labelling and post-market surveillance. Bureau Veritas will confirm the applicable submission requirements during the application process.