European medical device distribution glossary

A

AEMPS

Agencia Española de Medicamentos y Productos Sanitarios — Spain's medicines and medical devices regulator. Handles MDR/IVDR notifications and Spanish-specific economic operator registration.

Amgros

Danish publicly owned procurement organization that coordinates pharmaceutical and selected medical device purchasing for the 5 Regions.

ANSM

Agence nationale de sécurité du médicament et des produits de santé — France's medical device regulator. Required notifications for Class IIb and III devices.

Article 11 (MDR)

The provision of EU MDR 2017/745 requiring non-EU manufacturers to appoint an EU Authorized Representative (EC REP). The EC REP has joint regulatory liability.

Authorized Representative

See EC REP below. Non-EU manufacturer's regulatory proxy in the EU.

B

BBG (Bundesbeschaffung)

Austria's federal procurement entity. Runs framework agreements for federal public sector including medical devices.

BeschA

Beschaffungsamt — Germany's federal procurement office. Handles federal-level procurement; state-level handled by 16 Bundesländer.

BfArM

Bundesinstitut für Arzneimittel und Medizinprodukte — Germany's medicines and medical devices institute. Handles MDR/IVDR notifications and German economic operator registration under MPDG.

Broadliner

A medical device distributor with wide multi-brand inventory across many product categories, typically serving many customer types. Contrast with specialty distributor. Common in dental: Henry Schein, Plandent, dental bauer, Pluradent, Marrodent.

C

CE marking

Conformité Européenne — the regulatory marking indicating a medical device meets EU MDR or IVDR requirements. Class I is self-certified; Class IIa, IIb, III, IVDR B/C/D require Notified Body assessment.

CH-REP

Swiss Authorized Representative — required for non-Swiss manufacturers placing devices on the Swiss market post-2021 decoupling. Governed by Swissmedic MedDO regime.

Class I / IIa / IIb / III

EU MDR risk classification. Class I = low risk (gauze, examination gloves). Class IIa = medium risk (electrocardiograph, syringe). Class IIb = higher risk (anaesthesia, infusion). Class III = highest risk (implants, life-sustaining). Higher class = more conformity assessment.

Clinical Evaluation Report (CER)

Required documentation under MDR Article 61 demonstrating clinical safety and performance. See our CER practical guide.

CONSIP

Italian centralized procurement entity (Concessionaria Servizi Informativi Pubblici). Runs national framework agreements and the MePA electronic marketplace.

Coverage Planner

MDD's set-cover solver tool computing the minimum number of distributor contracts to cover target European countries for a given sub-vertical.

D

DACH

Germany (D) + Austria (A) + Switzerland (CH). Shared language and clinical culture make this a single commercial cluster despite separate regulatory regimes.

Direct sales model

Manufacturer builds its own country team (Country Manager, sales, KAMs, clinical) rather than using a distributor. Higher fixed cost, full margin retention.

Distributor

An independent commercial entity that buys medical devices from manufacturers and resells them to hospitals, clinics, labs. Holds stock, handles regulatory documentation, runs sales coverage. Earns a margin (typically 25–55%).

Distributor Matcher

MDD's free tool ranking 459+ verified European distributors against a manufacturer's product profile.

DMP

Direktoratet for medisinske produkter — Norway's medical products directorate. Handles MDR/IVDR notifications under EEA Agreement.

E

EC REP

European Authorized Representative — the regulatory proxy required for non-EU manufacturers under Article 11 MDR. Has joint liability and economic operator obligations.

EEA

European Economic Area — EU + Norway + Iceland + Liechtenstein. MDR applies through EEA Agreement.

EUDAMED

European Database on Medical Devices — the EU's central registry for devices, certificates, economic operators, vigilance reports. Required actor identification before placing devices on EU market.

EVB-IT

German federal IT procurement framework. Relevant for medical device IT, imaging informatics, EHR-adjacent products.

F

FAMHP

Federal Agency for Medicines and Health Products — Belgium's medical device regulator.

Fimea

Finnish Medicines Agency. Handles MDR/IVDR notifications and Finnish-specific economic operator registration.

Framework agreement

Public procurement contract awarding multi-year supply rights to one or more suppliers under preset terms. Common in NHS Supply Chain (UK), CONSIP (IT), SKL Kommentus (SE), Amgros (DK).

Fractional Sales Director

Outsourced Country Manager / commercial lead model — typically 0.3–1.0 FTE engagement. Faster than direct hire, more direct than distributor. Fractio's primary service offering.

G

GHT

Groupement Hospitalier de Territoire — France's 135 regional hospital groups that coordinate procurement. Major buying entities for medical devices in French public hospitals.

H

Hansel

Finland's central procurement organization. Runs framework agreements for state entities and selected wellbeing services counties.

HPRA

Health Products Regulatory Authority — Ireland's regulator for medical devices and medicines.

Hybrid model

Mix of direct sales (1–2 lead markets) plus distributors (remaining markets). Most common European model for established Europe-active manufacturers.

I

IGJ

Inspectie Gezondheidszorg en Jeugd — Netherlands' health and youth care inspectorate. Regulates medical devices.

IVDR

In Vitro Diagnostic Regulation 2017/746 — EU regulation for IVDs, fully applicable since 2022. Classes A/B/C/D based on patient risk.

K

KAM

Key Account Manager — sales role focused on large named hospital customers or clinic chains.

KOL

Key Opinion Leader — clinician with strong influence on peer prescribing or surgical adoption. Critical for high-complexity device categories (orthopedic, cardiovascular, dental implants).

L

Lægemiddelstyrelsen

Danish Medicines Agency — Denmark's medical device regulator.

Läkemedelsverket

Medical Products Agency — Sweden's medical device regulator.

Launch Timeline

MDD's free tool computing a realistic EU market-entry timeline from product class, MDR status, target countries, GTM model.

LPP

Liste des Produits et Prestations — France's reimbursement list for medical devices used in homecare and outpatient. Listing process separate from CE marking.

M

MDR

EU Medical Device Regulation 2017/745 — replaced the prior Medical Device Directive (MDD) in 2021. Applies to all EU/EEA medical device placement.

MedDO

Swiss Medical Devices Ordinance — Switzerland's standalone medical device regulation post-EU decoupling.

MePA

Mercato elettronico della Pubblica Amministrazione — Italy's electronic marketplace for public sector procurement, including medical devices.

MHRA

Medicines and Healthcare products Regulatory Agency — UK's regulator. Post-Brexit handles UKCA and UK MDR.

MPDG

Medizinprodukterecht-Durchführungsgesetz — Germany's national implementation law for EU MDR including the Medizinprodukteberater (medical device consultant) role.

N

NHS Supply Chain

UK's national medical device procurement entity for NHS. Runs 11 category framework towers (orthopedic, cardiovascular, surgical, etc.) on rolling 3–4 year cycles.

Notified Body (NB)

Independent assessment body designated to evaluate medical device conformity with EU MDR. Required for Class IIa+ and IVDR Class B/C/D. Backlogs of 4–9 months for new dossiers.

O

OneMed

Largest Nordic medical device distributor — operates in Sweden, Denmark, Norway, Finland. Stockholm HQ.

P

Pan-European Group

Distributor group operating in 2+ European countries. Only 15 such groups exist in our directory. See Pan-European Groups page.

PMCF

Post-Market Clinical Follow-up — ongoing clinical data collection required under MDR Article 61 and Annex XIV Part B.

PMS

Post-Market Surveillance — manufacturer's continuous monitoring of device performance and safety post-launch. Required under MDR Articles 83-92. See our PMS practical guide.

PSUR

Periodic Safety Update Report — annual or biennial PMS report required for Class IIa, IIb, III devices.

R

Repertorio dei Dispositivi Medici

Italy's medical device registry — devices must be notified before being placed in Italian hospitals. Administered by Ministero della Salute.

RESAH

Réseau des Acheteurs Hospitaliers — French national purchasing group for public hospitals.

S

SKL Kommentus

Swedish municipal and regional procurement entity — runs framework agreements consumed by 21 regional health authorities.

SPMS

Serviços Partilhados do Ministério da Saúde — Portugal's shared services entity for SNS (National Health Service). Runs centralized framework procurement.

Sub-vertical

The 8 categories MDD covers: dental, orthopedic, surgical instruments, diagnostic imaging, cardiovascular, IVD, capital equipment, consumables.

Sykehusinnkjøp HF

Norway's centralized hospital purchasing organization — runs framework procurement for 4 regional health authorities.

T

TED

Tenders Electronic Daily — EU's official Official Journal supplement publishing all above-threshold public tenders. ted.europa.eu

Tender

Public procurement competition for the right to supply a defined product / category to a public hospital, region, or national framework.

Tender Windows

MDD's free tool showing when public tenders typically open and close per country per sector.

U

UGAP

Union des Groupements d'Achats Publics — France's national public procurement framework operator.

UKCA

UK Conformity Assessed — UK's post-Brexit equivalent of CE marking. Required for placing medical devices on Great Britain market.

UKRP

UK Responsible Person — required for non-UK manufacturers placing devices on UK market. UK equivalent of EC REP.

URPL

Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych — Poland's medicines, medical devices, biocides registry.

V

Vigilance reporting

Mandatory reporting of serious incidents, field safety corrective actions, and trend reports under MDR Articles 87-92.