CE mark indicates that medical device in the EU complies with the applicable EU regulations. CE marking enables the commercialization of products in European countries.
Medical devices need to comply with regulation (EU) 2017/745 of the European Parliament and the Council of April 5th, 2017 on medical devices, amending Directive 2001/83/EC. This is current regulation will be in force from May 26th, 2021.
Medical devices must undergo conformity assessment to ensure that devices are safe, meet specific performance standards, quality and perform as intended. Depending on the class of medical device, self-declaration or involvement of notified body is determined.
Key Players in CE Marking Process:
Competent Authority (CA) is a member state organization responsible for market surveillance to ensure that devices comply with regulations and do not endanger the health or safety of any public.
Notified Body is a conformity assessment body designated by a member state to undertake conformity assessment activities for medical.
Economic Operator is a manufacturer, an authorized representative, an importer, a distributor, or a legal person.
The manufacturer is the one who markets a device under its name or trademark.
Authorized Representative or EC Rep is in the European Union which acts on behalf of a manufacturer in relation to the specific tasks regarding written mandate according to EUMDR with the manufacturer established outside the EU.
The importer is a person within the European Union the places a device from a third country on the union market.
A distributor is a person in the supply chain other than the manufacturer or the importer, making a device available on the market until the point of putting it into service.
CE Marking Process
What we offer
- Register your medical devices for MDL/MDEL.
- Keep you up to date with the Canadian regulatory requirement.
- Help you with MDSAP & ISO 13485 certificate
Why Choose Us
- Working towards client satisfaction
- Cost effective solutions
- Project completion before deadline
- Quality Regulatory affairs solutions
- Act as your EU Authorised Representative
- Regulatory Strategy: Expertise on all regulatory strategies with the new device or device changes, upgrades, revisions to get compliant with EU-MDR Regulatory
- Gap Analysis EU MDD to EU MDR
- Technical Document Compilation (Technical Files)
- Labelling & Packaging requirements
- UDI Setup
- EUDAMED Registration
- Local listing within the EU
- Post Market Support Activities
- Clinical evaluation documentation
- Risk management Studies
Contact us for free consultation: [email protected]