Achieve CE Marking for your Medical Devices
WHAT IS THE PURPOSE OF CE MARKING FOR MEDICAL DEVICES?
To access the European Union market, Medical Devices must obtain CE Marking in accordance with Medical Device Regulation (EU) 2017/745 - MDR. This Regulation governs the process of placing medical devices and related accessories on the market, their commercialization, and their use for human purposes. It also applies to non-medical devices listed in Annex XVI.
Bureau Veritas is a Notified Body (no. 1370) for conformity assessment and issuance of CE Marking for Medical Devices in accordance with Medical Device Regulation (EU) 2017/745 – MDR covering all risk classes (Ir, Is, Im, IIa, IIb and III).
Bureau Veritas Switzerland thanks to the local presence of qualified personnel dedicated only to Swiss manufacturers can ensure immediate availability and delivery with reliable deadlines at all stages, from pre- to post-certification.
Our local presence, combined with global expertise in 140 countries, positions us uniquely to support your certification needs efficiently and effectively.
Structured Dialogue with Bureau Veritas
At Bureau Veritas Switzerland we understand the importance to clarifying expectations and regulatory requirements to enhance the efficiency and predictability of the conformity assessment process, while respecting the independence and impartiality of the Notified Body.
Contact us if you wish to start the CE Marking journey for your product. Upon your request, we will contact you to organize a meeting to provide regulatory guidance on the following topics:
- Comprehensive overview of the certification process, including pre-application and application processes
- Clarification on the data / documentation to be provided with the application
- Timelines for conformity assessment until certification
- Pricing and fees
- Applicable standards and guidance document
- Qualification and Classification of a product
- Best practice guidance for technical documentation (TD), including preferred structure of TD.
Medical Device Product Development Leader
Would you like more information? We are always available to offer you solutions tailored to your needs. Please fill out the form below, and we will contact you back.