Regulatory strategy
Initial assessment, device classification and development of the full approval roadmap in the country.
MDR/IVDR
Register your medical device in the European Union.
Obtain CE marking under the MDR (2017/745) or IVDR (2017/746) through a Notified Body, with an EU Authorised Representative and a GSPR technical dossier.
Speak to a specialistThe authority
Comissão Europeia (regulamentação) + Autoridades Nacionais (vigilância) + Notified Bodies (avaliação)
MDR/IVDR
Regulatory authority
European Union
A decentralised system in which the European Commission issues MDR and IVDR regulations, national authorities supervise compliance and private Notified Bodies perform technical device assessments.
Visit the official websiteRegulatory framework
Main legislation and risk classes
| Class | Description | Examples |
|---|---|---|
| Class I | Low risk. Non-sterile or without a measuring function: self-declaration | Bandages, spectacles, non-critical reusable surgical instruments |
| Class IIa | Low-to-moderate risk, requiring a Notified Body | Contact lenses, ultrasound diagnostic equipment |
| Class IIb | Moderate-to-high risk, requiring a Notified Body | Infusion pumps, X-ray equipment |
| Class III | High risk, requiring a Notified Body and intensive clinical review | Cardiac implants, hip prostheses, valves |
Registration process
How we manage your project
- 01
Classification2-4 weeks
Apply the 22 rules in Annex VIII, Chapter III of the MDR
- 02
ISO 13485 QMS4-8 months
A quality management system certified to ISO 13485
- 03
GSPR technical dossier3-6 months
Document conformity with the General Safety and Performance Requirements
- 04
Authorised Representative2 weeks
Appoint an EU AR (mandatory for manufacturers outside the Union)
- 05
Notified Body audit3-6 months
Class IIa and above: QMS audit and technical dossier review
- 06
CE Marking and EUDAMED1-2 months
Receive the certificate, apply CE marking and register in EUDAMED
Total timeframe6 to 18 months, depending on risk class
Local representativeAuthorised Representative (AR)
Approximate costOn request
Post-market
Post-approval obligations
| Area | Requirement |
|---|---|
| Surveillance | EUDAMED database, PMCF (Post-Market Clinical Follow-up) and PSUR for Class IIb and above |
| Renewal | Renewable five-year Notified Body certificate |
| Required QMS | ISO 13485 and GSPR (General Safety and Performance Requirements) |
How HSC helps
CE Marking in 6 to 12 months, with the right Notified Body for your class.
Technical dossier
Document preparation and translation in accordance with local requirements, including responses to deficiencies and requests.
Local representation
Acting directly as legal representative or recommending an authorised partner accredited by the authority.
Ongoing post-market support
Monitoring regulatory changes, renewals, surveillance and responses to authority audits.
Frequently asked questions
Questions about MDR/IVDR
Next step
Ready to start your project in the European Union?
Speak to our team for an initial assessment of your product and the most efficient regulatory pathway.
Speak to a specialist