20,698 written agreements
Notified bodies and manufacturers had signed 20,698 written agreements under the MDR up to 28 February 2026.
European Commission (DG SANTE study, Gesundheit Österreich GmbH)989 applications refused
Notified bodies had refused 989 MDR applications up to 28 February 2026.
European Commission (DG SANTE study, Gesundheit Österreich GmbH)12,036 QMS certificates
Notified bodies had issued 12,036 MDR quality-system (QMS) certificates up to 28 February 2026, of which 6,373 were first-time.
European Commission (DG SANTE study, Gesundheit Österreich GmbH)Why this market is moving now
- Legacy-device transition periods end on 31 December 2027 or 2028 depending on risk class.
- The Commission proposed simplified rules on 16 December 2025; the proposal still needs Parliament and Council adoption.
- Only 6,203 product certificates had been issued by 28 February 2026, against 31,902 applications lodged.
Key figures
Each figure links to the page it came from.
| Figure | Value | Year | Source |
|---|---|---|---|
| Manufacturers had lodged 31,902 MDR certification applications with notified bodies from designation up to 28 February 2026. | 31,902 applications | 2026 | European Commission (DG SANTE study, Gesundheit Österreich GmbH) |
| Notified bodies and manufacturers had signed 20,698 written agreements under the MDR up to 28 February 2026. | 20,698 written agreements | 2026 | European Commission (DG SANTE study, Gesundheit Österreich GmbH) |
| Notified bodies had refused 989 MDR applications up to 28 February 2026. | 989 applications refused | 2026 | European Commission (DG SANTE study, Gesundheit Österreich GmbH) |
| Notified bodies had issued 12,036 MDR quality-system (QMS) certificates up to 28 February 2026, of which 6,373 were first-time. | 12,036 QMS certificates | 2026 | European Commission (DG SANTE study, Gesundheit Österreich GmbH) |
| Notified bodies had issued 6,203 MDR product certificates up to 28 February 2026, of which 3,291 were first-time. | 6,203 product certificates | 2026 | European Commission (DG SANTE study, Gesundheit Österreich GmbH) |
| 52 notified bodies were designated for medical devices under the MDR at the time of the survey (data to 28 February 2026). | 52 notified bodies | 2026 | European Commission (DG SANTE study, Gesundheit Österreich GmbH) |
| Under Regulation (EU) 2023/607, legacy devices can benefit from a transitional period until 31 December 2027 or 31 December 2028, depending on risk class, if conditions are met. | 31 December 2027 / 31 December 2028 transition end dates | 2027 | European Commission |
| On 16 December 2025 the European Commission proposed a targeted simplification of the EU medical device rules. | 16 December 2025 date of proposal | 2025 | European Commission, Public Health |
| The MDR (Regulation (EU) 2017/745) has applied since 26 May 2021. | 26 May 2021 date of application | 2021 | European Commission, Public Health |
What the full report covers
- 1
Executive summary
The answer on two pages: size, growth and what drives it.
- 2
Market size and outlook
History, the current year and a five-year view with base, low and high cases.
- 3
Segments and regions
Splits by product, buyer and geography across the US, Europe and MEA.
- 4
Company profiles
The main players, how they compete and where they are investing.
- 5
Data and method
Every figure in Excel, with the sources and assumptions behind it.
- 01Executive summary
The answer in one page: size, direction and what moves it - 02Market definition and scope
What is in and out of the European Union market - 03Market size, 2021 to 2025
Historical series and growth rates - 04Outlook to 2031
Base, low and high scenarios with stated assumptions - 05Rules, policy and deadlines
Regulation and programmes that change demand - 06Drivers and barriers
What accelerates or slows adoption, by customer segment - 07Prices, costs and margins
Unit economics where public data allows - 08Competitive landscape
8 to 12 company profiles with recent moves - 09Opportunities and risks
For new entrants, suppliers and investors - 10Method and sources
Every assumption and source, listed
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Frequently asked questions
When does the EU MDR transition period end?
The European Commission's Q&A on Regulation (EU) 2023/607 says legacy devices can benefit from the transitional period until 31 December 2027 or 31 December 2028, as applicable, if conditions are met.
How many notified bodies are designated under the MDR?
The Commission's 20th notified body survey lists 52 notified bodies designated for medical devices as of data to 28 February 2026.
How many MDR certificates have been issued?
The survey counts 12,036 QMS certificates and 6,203 product certificates issued under the MDR up to 28 February 2026.
How many MDR applications have been filed?
Manufacturers had lodged 31,902 applications with notified bodies up to 28 February 2026, and 20,698 written agreements were signed.
Are the MDR rules being changed?
On 16 December 2025 the European Commission proposed a targeted simplification of the medical device rules. It must still be adopted by the European Parliament and the Council.
Sources and method
The figures on this page come from the public sources listed below. Read how we work.
- European Commission (DG SANTE study, Gesundheit Österreich GmbH): Survey results of the 20th NB survey (MDR/IVDR) with data status 28 February 2026 (2026-07-02)
31.902
- European Commission (DG SANTE study, Gesundheit Österreich GmbH): Survey results of the 20th NB survey (MDR/IVDR) with data status 28 February 2026 (2026-07-02)
Number of written agreements signed (from designation up to 28/02/2026) 20.698
- European Commission (DG SANTE study, Gesundheit Österreich GmbH): Survey results of the 20th NB survey (MDR/IVDR) with data status 28 February 2026 (2026-07-02)
Number of applications refused for MDR (from designation up to 28/02/2026) 989
- European Commission (DG SANTE study, Gesundheit Österreich GmbH): Survey results of the 20th NB survey (MDR/IVDR) with data status 28 February 2026 (2026-07-02)
Total number of QMS certificates issued for MDR (from designation up to 28/02/2026) 12.036
- European Commission (DG SANTE study, Gesundheit Österreich GmbH): Survey results of the 20th NB survey (MDR/IVDR) with data status 28 February 2026 (2026-07-02)
Total number of product certificates issued for MDR (from designation up to 28/02/2026) 6.203
- European Commission (DG SANTE study, Gesundheit Österreich GmbH): Survey results of the 20th NB survey (MDR/IVDR) with data status 28 February 2026 (2026-07-02)
Designated NBs for MD: 52
- European Commission: Extension of the MDR transitional period and removal of the 'sell off' periods: Q&A on Regulation (EU) 2023/607 (Rev. 2) (2024-07)
the device benefits from the full transitional period until 31 December 2027 or 31 December 2028, as applicable
- European Commission, Public Health: Medical Devices - New regulations: Overview (2026)
On 16 December 2025, the European Commission proposed a targeted simplification of the current rules for medical devices
- European Commission, Public Health: Medical Devices - New regulations: Overview (2026)
With effect from 26 May 2021, Regulation (EU) 2017/745
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