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Article 103

Reproduced from official EUR-Lex 10/1/2025.

Article 103

Data protection

1.

Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation.

2.

Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation.

Official catalogue · non-binding

Related guidance (29)

Current English catalogue entries that refer to Article 103. Guidance is non-binding and kept separate from the regulation text.

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Manual on BorderlineManual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 Background note on the use of the Manual on borderline and classification for medical devices under the Directives.April 2026
Non-binding guidanceOpen guidance page
Catalogue section
Borderline and Classification
Published
April 2026
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  • Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5PDF · Unverified extraction previewOfficial source

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  • Background notePDF · Unverified extraction previewOfficial source

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MDCG 2025-5Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746June 2025
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
June 2025
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  • MDCG 2025-5PDF · Unverified extraction previewOfficial source

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MDCG 2022-12Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)July 2022
Non-binding guidanceOpen guidance page
Catalogue section
EUDAMED
Published
July 2022
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  • MDCG 2022-12PDF · Unverified extraction previewOfficial source

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MDCG 2021-13 rev.1Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDRJuly 2021
Non-binding guidanceOpen guidance page
Catalogue section
EUDAMED
Published
July 2021
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  • MDCG 2021-13 rev.1PDF · Unverified extraction previewOfficial source

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MDCG 2023-1Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746January 2023
Non-binding guidanceOpen guidance page
Catalogue section
In-house devices
Published
January 2023
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  • MDCG 2023-1PDF · Unverified extraction previewOfficial source

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MDCG 2021-27 - rev.1Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746December 2023
Non-binding guidanceOpen guidance page
Catalogue section
Authorised Representatives, Importers, Distributors
Published
December 2023
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  • MDCG 2021-27 - rev.1PDF · Unverified extraction previewOfficial source

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MDCG 2022-16Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746October 2022
Non-binding guidanceOpen guidance page
Catalogue section
Authorised Representatives, Importers, Distributors
Published
October 2022
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  • MDCG 2022-16PDF · Unverified extraction previewOfficial source

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MDCG 2021-26Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746October 2021
Non-binding guidanceOpen guidance page
Catalogue section
Authorised Representatives, Importers, Distributors
Published
October 2021
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  • MDCG 2021-26PDF · Unverified extraction previewOfficial source

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Show all 29 guidance documentsShow only the first 8
MDCG 2024-4 MDCG 2024-4 AppendixSafety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746Appendix – Performance Study Summary Safety Reporting FormApril 2024
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
April 2024
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  • MDCG 2024-4PDF · Unverified extraction previewOfficial source

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  • MDCG 2024-4 AppendixXLSM · Unverified extraction previewOfficial source

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MDCG 2020-16 rev.4Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746March 2025
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
March 2025
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  • MDCG 2020-16 rev.4PDF · Unverified extraction previewOfficial source

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MDCG 2022-20Substantial modification of performance study under Regulation (EU) 2017/746December 2022
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
December 2022
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  • MDCG 2022-20PDF · Unverified extraction previewOfficial source

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MDCG 2022-19Performance study application/notification documents under Regulation (EU) 2017/746December 2022
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
December 2022
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  • MDCG 2022-19PDF · Unverified extraction previewOfficial source

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MDCG 2022-15Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDDSeptember 2022
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
September 2022
Topics

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  • MDCG 2022-15PDF · Unverified extraction previewOfficial source

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MDCG 2021-22 rev.1Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746September 2022
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
September 2022
Topics

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  • MDCG 2021-22 rev.1PDF · Unverified extraction previewOfficial source

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MDCG 2022-6Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDRMay 2022
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
May 2022
Topics

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  • MDCG 2022-6PDF · Unverified extraction previewOfficial source

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MDCG 2021-4 rev.1Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746September 2024
Non-binding guidanceOpen guidance page
Catalogue section
In Vitro Diagnostic medical devices (IVD)
Published
September 2024
Topics

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  • MDCG 2021-4 rev.1PDF · Unverified extraction previewOfficial source

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MDCG 2025-4Guidance on the safe making available of medical device software (MDSW) apps on online platformsJune 2025
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
June 2025
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  • MDCG 2025-4PDF · Unverified extraction previewOfficial source

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MDCG 2020-1Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device softwareMarch 2020
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
March 2020
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  • MDCG 2020-1PDF · Unverified extraction previewOfficial source

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MDCG 2019-11 rev.1Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746June 2025
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
June 2025
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  • MDCG 2019-11 rev.1PDF · Unverified extraction previewOfficial source

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MDCG 2021-23Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746August 2021
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
August 2021
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  • MDCG 2021-23PDF · Unverified extraction previewOfficial source

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MDCG 2021-14Explanatory note on IVDR codesJuly 2021
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
July 2021
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  • MDCG 2021-14PDF · Unverified extraction previewOfficial source

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MDCG 2020-14Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)August 2020
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
August 2020
Topics

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  • MDCG 2020-14PDF · Unverified extraction previewOfficial source

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MDCG 2019-13 rev.1Guidance on sampling of devices for the assessment of the technical documentationDecember 2024
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
December 2024
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  • MDCG 2019-13 rev.1PDF · Unverified extraction previewOfficial source

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MDCG 2019-7 - rev.1Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)December 2023
Non-binding guidanceOpen guidance page
Catalogue section
Person responsible for regulatory compliance (PRRC)
Published
December 2023
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  • MDCG 2019-7 - rev.1PDF · Unverified extraction previewOfficial source

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MDCG 2023-3 rev.2Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746January 2025
Non-binding guidanceOpen guidance page
Catalogue section
Post-Market Surveillance and Vigilance (PMSV)
Published
January 2025
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  • MDCG 2023-3 rev.2PDF · Unverified extraction previewOfficial source

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MDCG 2018-7Provisional considerations regarding language issues associated with the UDI databaseOctober 2018
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
October 2018
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  • MDCG 2018-7PDF · Unverified extraction previewOfficial source

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MDCG 2018-6Clarifications of UDI related responsibilities in relation to article 16October 2018
Non-binding guidanceOpen guidance page
Catalogue section
Unique Device Identifier (UDI)
Published
October 2018
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  • MDCG 2018-6PDF · Unverified extraction previewOfficial source

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MDCG 2022-11 - rev.1MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR and IVDR requirementsNovember 2023
Non-binding guidanceOpen guidance page
Catalogue section
Other topics
Published
November 2023
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  • MDCG 2022-11 - rev.1PDF · Unverified extraction previewOfficial source

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MDCG 2022-14Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDsAugust 2022
Non-binding guidanceOpen guidance page
Catalogue section
Other topics
Published
August 2022
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  • MDCG 2022-14PDF · Unverified extraction previewOfficial source

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