A CE mark grants the legal right to sell a medical device in the EU. It does not tell any hospital, insurer, or health system what that device is worth. Health Technology Assessment (HTA) is the process that answers the worth question, and from January 2025 selected high-risk devices face a new EU-level layer through Joint Clinical Assessments under Regulation (EU) 2021/2282.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • CE marking under MDR and HTA are two separate gates: one proves safety and performance, the other proves comparative value to a payer.
  • Regulation (EU) 2021/2282 (the HTA Regulation) introduces EU-level Joint Clinical Assessments (JCA) that started applying to certain medical devices from 12 January 2025 for a defined scope.
  • National HTA bodies (IQWiG in Germany, HAS in France, NICE in England, AIHTA in Austria, and others) continue to run parallel national assessments on price and reimbursement.
  • The clinical evidence demanded by HTA bodies typically goes beyond MDR Article 61 requirements: comparators, patient-relevant outcomes, and economic modelling.
  • Founders who plan one integrated evidence stack — designed from day one to satisfy MDR, HTA, and payers — avoid the expensive pattern of running a second clinical study after CE mark.
  • HTA timelines are long. If reimbursement matters to your business model, HTA planning starts before the clinical investigation plan is locked.

Why HTA decides whether your device actually sells

A founder walks into our office with a fresh CE certificate and a pitch deck that assumes rapid adoption across three European markets. The device works, the notified body signed off, the labelling is clean. Six months later the same founder is burning cash because no hospital in Germany will put the device on a procurement list, no French public hospital can find a billing code, and the Austrian social insurance is asking for a full cost-effectiveness dossier before they discuss a price.

This is the HTA gap. The MDR tells you whether you are legally allowed to place a device on the EU market. It says nothing about whether anyone has to pay for it. That second question is owned by HTA bodies and payers, and they operate on a different logic, a different evidence standard, and a different timeline from the notified body.

For startups, the consequence is simple: if your business model depends on reimbursement — and for most Class IIa and above devices it does — then HTA is not an afterthought that follows CE marking. It is a parallel process that should shape your clinical evidence strategy from the start.

What the rules actually say

Two distinct regulatory regimes are in play, and founders routinely confuse them.

The MDR side. MDR Article 61 requires a clinical evaluation that demonstrates conformity with the General Safety and Performance Requirements (GSPR), covering safety, clinical performance, and an acceptable benefit-risk ratio. Annex XIV Part A governs the clinical evaluation plan and report. This is a regulatory gate: pass it and the notified body can issue a certificate.

The HTA side. Regulation (EU) 2021/2282 (the "HTA Regulation") established a permanent EU framework for Health Technology Assessment. It entered into application on 12 January 2025 for an initial scope, and it introduces Joint Clinical Assessments (JCA) at EU level for specific categories of high-risk medical devices and in-vitro diagnostics, in addition to medicinal products. The detailed scope, timing, and procedural rules are set in the Regulation and its implementing acts — founders working on devices that might fall inside the medical device JCA scope should confirm current scope with a regulatory lead before committing to a trial design.

Below the EU layer, national HTA bodies keep their existing roles. IQWiG and the G-BA in Germany, HAS in France, NICE in England (non-EU but often referenced), AIHTA in Austria, AEMPS and the Spanish regional bodies, and others each run their own appraisal processes and feed into national pricing and reimbursement decisions.

In plain language: the EU JCA can produce one shared clinical assessment that Member States "take into account" — but pricing, reimbursement coding, and actual market uptake remain national decisions.

The critical evidence overlap. MDR clinical evaluation (Article 61, Annex XIV) asks: does the device do what the manufacturer claims, safely, for the intended population? HTA asks: compared to what is already reimbursed, how much better is it, for whom, at what cost, with what impact on the health system? The first question can sometimes be answered with literature, bench data, and a modest clinical investigation. The second almost always needs a comparator, patient-relevant endpoints (not just surrogate markers), and a health-economic model.

A worked example

A 12-person startup in Graz is developing a Class IIb wearable for early detection of atrial fibrillation. The founders have budgeted for a clinical investigation of 240 patients, designed to support MDR Article 61 evidence and Annex XIV Part A requirements. Single arm, surrogate endpoint, 6-month follow-up. Clean, lean, CE-mark focused.

We run the HTA overlay. The main target market is Germany. To get onto the statutory reimbursement pathway for digital health applications or into the DRG system for hospital use, the device will need a comparative assessment. IQWiG will want a randomised comparison against current standard of care (Holter or event recorder), patient-relevant outcomes (stroke events, anticoagulation initiation, quality of life), and ideally 12-month data. France's HAS will want similar, plus sub-group analysis for elderly patients. The AIHTA in Austria will want a budget impact model.

The startup has two choices. Option A: finish the single-arm MDR study, get the CE mark in 18 months, then start a second study for HTA. That adds 24 to 36 months and roughly doubles the clinical budget. Option B: redesign the single study now as a randomised controlled trial with patient-relevant endpoints and a pre-specified health-economic analysis plan. The trial gets larger (say 400 patients), more expensive, and slower — but it is the only trial they have to run. CE mark slips by perhaps 6 months; market access accelerates by 18.

We chose Option B. The founder's response was the same one we hear every time: "I wish someone had told me this before we wrote the clinical investigation plan."

The Subtract to Ship playbook

This is where subtracting works: you cut the second trial, not the first.

Step 1 — Map the business model before the clinical plan. If your device is self-pay, cash-based, or sold as a wellness companion, HTA may not apply at all. If hospitals, national insurers, or Krankenkassen are in the target customer list, HTA applies even when it is not yet a formal requirement. Write this down before you write a protocol.

Step 2 — Identify the two or three HTA bodies that matter. Most European MedTech startups do not need to please every EU27 HTA body. Pick the two or three that define your beachhead market. Read their published methods documents. Look at the last three medical-device dossiers they appraised in your therapeutic area. You will see patterns: what comparator they accept, what endpoints count, what rejection language looks like.

Step 3 — Check JCA scope. For devices that may fall inside the EU-level JCA scope under (EU) 2021/2282, the clinical assessment increasingly becomes a single EU-level exercise. For devices outside that scope, national processes remain the relevant target. In both cases, the evidence standard is closer to HTA than to minimum-MDR.

Step 4 — Design one integrated evidence stack. The MDR Article 61 clinical evaluation, the HTA clinical assessment, and the payer dossier should share the same core study whenever possible. That means: comparator arm, patient-relevant primary endpoint, pre-specified health-economic analysis, and a long enough follow-up window to capture outcomes payers care about. You will need specialist health-economics input early, not after the CE mark.

Step 5 — Budget HTA realistically. National HTA submissions cost time (6 to 18 months) and money (tens to hundreds of thousands of euros per country, depending on the process and whether you need external dossier support). Put line items into the funding plan before Series A.

Step 6 — Build the pricing story into the CER. Your clinical evaluation report, when written well, can double as the clinical backbone of an HTA dossier. Structure it so comparative data and patient-relevant outcomes are visible, not buried.

Reality Check

  1. Do you know which two or three HTA bodies will decide whether your device gets reimbursed in your beachhead market?
  2. Have you read at least one recent published HTA appraisal in your therapeutic area?
  3. Does your current clinical investigation plan include a comparator arm and patient-relevant outcomes, or only surrogate endpoints?
  4. Have you checked whether your device type falls within the current scope of EU Joint Clinical Assessments under Regulation (EU) 2021/2282?
  5. Is there a health-economic model — even a rough one — in your evidence plan?
  6. Does your cash runway cover CE mark plus HTA submission, or only CE mark?
  7. Have you talked to a health-economics specialist before locking the clinical investigation plan?
  8. Can your current CER structure support an HTA dossier, or would it need to be rewritten?

Frequently Asked Questions

Do I need an HTA submission to sell my device in Europe? Not legally. A CE mark is sufficient to place a device on the EU market. HTA decides whether public or statutory health systems will pay for it. For cash-pay or private-hospital sales, HTA may not be relevant. For anything routed through public reimbursement, HTA is the gate that matters after CE.

Is the EU HTA Regulation the same as MDR? No. MDR (Regulation (EU) 2017/745) is product regulation: safety, performance, CE mark. The HTA Regulation (EU) 2021/2282) is about comparative clinical assessment for reimbursement decision-making. They are separate instruments with different scopes, different authorities, and different evidence standards.

Does a Joint Clinical Assessment replace national HTA? No. The JCA provides a shared clinical assessment that Member States take into account, but pricing and reimbursement remain national competences. You may still need national dossiers after a JCA.

Can I use my MDR Clinical Evaluation Report as an HTA dossier? Parts of it, yes — especially the clinical data summary and literature review. But a CER is structured to answer MDR conformity questions, not comparative value questions. Expect to build a dedicated HTA dossier on top of the CER data.

When should we start thinking about HTA? Before the clinical investigation plan is locked. Once you have fixed your comparator (or lack of one), endpoints, and sample size, retrofitting for HTA means a second study.

Who pays for HTA work in a startup? The same funding round that pays for CE mark. Treat HTA preparation as part of the go-to-market budget, not a post-launch expense.

Sources

  1. Regulation (EU) 2017/745 on medical devices, consolidated text. Article 61, Annex XIV Part A.
  2. Regulation (EU) 2021/2282 on health technology assessment and amending Directive 2011/24/EU.
  3. EN ISO 14155:2020+A11:2024 — Clinical investigation of medical devices for human subjects — Good clinical practice.