CE marking – Medical Devices
What is CE marking for medical devices?
The CE Marking for medical devices is a mandatory conformity mark that demonstrates a device’s compliance with the essential requirements established by the applicable European regulations. Medical devices must obtain CE Marking before being placed on the market or put into service within the European Union (EU) and the European Economic Area (EEA).
From Directive 93/42/EEC to Regulation (EU) 2017/745 (MDR)
From 2003 to 2017, CE compliance for medical devices was governed by Directive 93/42/EEC (MDD).
In 2017, the Directive was replaced by Regulation (EU) 2017/745 (MDR), which—being a regulation—does not require transposition into national laws and is directly applicable in all EU Member States.
The MDR establishes:
strict safety, performance, and quality requirements
the definition of a medical device
the documentation required throughout the lifecycle:
design, manufacturing, conformity assessment, market placement, and post-market surveillance (PMS)
Its purpose is to ensure that medical devices marketed in Europe meet high standards of safety and clinical effectiveness, protecting public health and patient safety.
Medical Device Classification Under MDR
Regulation (EU) 2017/745 classifies medical devices into four risk classes:
Class I – CE Marking without a Notified Body (manufacturer self-certification, except for sterile/measuring/reusable surgical devices)
Class IIa
Class IIb
Class III
For all classes except Class I, manufacturers must undergo a conformity assessment performed by a Notified Body (NB).
Role of Notified Bodies in CE Marking
Notified Bodies are independent third-party organisations designated to assess the conformity of medical devices.
The official list of Notified Bodies authorised under MDR is available in the European Commission’s NANDO database (New Approach Notified and Designated Organisations).
Validity of the CE Certificate
The duration of the CE Marking certificate may vary depending on the selected Notified Body.
Under MDR, CE certificates typically have a validity of up to 5 years, after which renewal or re-certification is required.
How can we help you?
CE Marking Consulting Services
Orlando Engineering & Consulting provides specialized support both for obtaining new CE certifications and for maintaining existing certifications for medical devices under Regulation (EU) 2017/745 (MDR).
Technical Documentation and Regulatory Support
We assist manufacturers in preparing the full set of technical documentation required for CE Marking, including the Project File, Technical File, STED, and all additional documents necessary for compliance and conformity assessment.
Our consultancy services can cover a single phase of the certification process or extend across the entire lifecycle of a medical device, from initial concept to market placement and post-market activities.
Our CE Marking Consulting Process
When full support is required, our service is structured into the following key phases:
1. Preliminary Meeting (Free and Non-Binding)
An on-site or remote meeting to analyse operational needs, understand the device, and define the scope of work before issuing a tailored offer.
2. Strategic Planning and Resource Assessment
A joint evaluation with company management to identify the most effective strategy for the conformity assessment process, determine timelines, and define the resources required.
3. Periodic Meetings and Project Coordination
Regular meetings—at a frequency agreed with management—to monitor progress, coordinate activities, and ensure alignment with MDR requirements.
4. Support in Technical Documentation and Pre-Audit Checks
Assistance in drafting and reviewing documentation, and conducting internal verification audits prior to the official Notified Body audit.
5. Assistance During the Notified Body Audit
Full support during the certification audit, including guidance in managing non-conformities, clarifications, and observations raised by the Notified Body until complete resolution.