ImportRules

Selling medical devices in the EU — MDR, IVDR, notified body, UDI

Medical devices are the strictest product regime in the EU: notified-body certification for most classes, UDI registration in EUDAMED, and an authorised representative established in the EU. This page covers the full route.

The MDR/IVDR regime is where compliance costs are highest — and where the cost of getting it wrong is highest too. Get specialist help early.

The questions

Which rules apply to medical devices in the EU?

The Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). These are the strictest product regimes in the EU: notified-body involvement for most devices, UDI registration, and an authorised representative established in the EU for non-EU manufacturers.
Source: Regulation (EU) 2017/745 (MDR); Regulation (EU) 2017/746 (IVDR). Checked: 4 September 2026.

Do I need an authorised representative for medical devices?

Yes — non-EU manufacturers must designate an EU authorised representative (Article 11 MDR) whose name and address appear on the labelling. This is a different role from the GPSR Responsible Person and carries device-specific duties: registration, technical documentation, and regulatory compliance.
Source: Regulation (EU) 2017/745, Article 11. Checked: 4 September 2026.

What are the device classes and how are they determined?

Class I (lowest risk — self-certified), Class IIa and IIb (notified body), Class III (notified body with more intensive review). The class determines whether a notified body must certify before CE marking and what conformity-assessment route applies. Classification rules are in Annex VIII of the MDR.
Source: Regulation (EU) 2017/745, Annex VIII. Checked: 4 September 2026.

What is UDI registration?

Unique Device Identification: every device must carry a UDI carrier (barcode or RFID) encoding the device identifier and production identifier. The UDI must be registered in EUDAMED, the European database for medical devices. Compliance deadlines rolled out by device class from 2021 onward.
Source: Regulation (EU) 2017/745, Article 27 and Chapter III. Checked: 4 September 2026.

What does medical-device compliance cost?

The highest in the product-compliance spectrum. Notified-body certification for Class IIa: €10,000–€30,000. Class III: €50,000–€150,000 or more. Authorised representative service: €2,000–€10,000/year. UDI and EUDAMED registration on top. The cost reflects the risk — and the liability.
Source: Market pricing from notified bodies and authorised representatives. Checked: 4 September 2026.

Who can help?

The provider list includes medical-device specialists (Qserve, QbD/Qarad among them). Or ask for three introductions.
Source: Editorial list, checked 4 September 2026.

Who can help with cosmetics

Companies active in this category. Editorial and unpaid; being listed says nothing about quality beyond what they publish about themselves.

This section is being expanded. Companies that provide CPNP notification, PIF, safety assessment (CPSR), Responsible Person for cosmetics can request an extended listing or contact us for inclusion.
CompanyBasedWhat they publish about themselves
Biorius
biorius.com		BelgiumCosmetics specialist, safety assessment, CPNP
COSlaw
coslaw.eu		NetherlandsCosmetics regulatory affairs
Delphic HSE
delphic-hse.co.uk		UKCosmetics safety assessment

Who can help with supplements

Companies active in this category. Editorial and unpaid; being listed says nothing about quality beyond what they publish about themselves.

This section is being expanded. Companies that provide Novel food status, notification per member state, labelling can request an extended listing or contact us for inclusion.
CompanyBasedWhat they publish about themselves
Freyr
freyreglobal.com		GlobalFood supplement registration across EU
QualitySmart Solutions
qualitysmartsolutions.com		EUNovel food determination, supplement compliance

Who can help with medical

Companies active in this category. Editorial and unpaid; being listed says nothing about quality beyond what they publish about themselves.

This section is being expanded. Companies that provide MDR/IVDR notified body, authorised representative, UDI registration can request an extended listing or contact us for inclusion.
CompanyBasedWhat they publish about themselves
Qserve Group
qservegroup.com		NetherlandsMDR specialist, operating since 1998
QbD / Qarad
qarad.com		BelgiumIVD specialist, operating since 2000
BSI Group
bsigroup.com		UK/GlobalNotified body for MDR