LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)
1.
Contact lenses or other items intended to be introduced into or onto the eye.
2.
Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.
3.
Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.
4.
Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
5.
High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
6.
Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.
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Related guidance (30)
Current English catalogue entries that refer to Annex XVI. Guidance is non-binding and kept separate from the regulation text.
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MDCG 2023-5Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodiesDecember 2023⌄
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Q&AQ&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDRSeptember 2023⌄
Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDRPDF · Unverified extraction previewOfficial source
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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⌄
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MDCG 2021-24 rev.1Guidance on classification of medical devicesApril 2026⌄
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MDCG 2019-15 rev.1Guidance notes for manufacturers of class I medical devicesDecember 2019⌄
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MDCG 2024-10Clinical evaluation of orphan medical devicesJune 2024⌄
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MDCG 2024-5 MDCG 2024-5 Appendix AGuidance on the Investigator’s Brochure contentAppendix A of the MDCG 2024-5April2024April2024⌄
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Show all 30 guidance documentsShow only the first 8
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MDCG 2020-13 - Word versionClinical evaluation assessment report templateJuly 2020⌄
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Word versionDOCX · Unverified extraction previewOfficial source
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MDCG 2020-5Guidance on clinical evaluation – EquivalenceApril 2020⌄
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MDCG 2019-9 - rev.1Summary of safety and clinical performanceMarch 2022⌄
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MDCG 2026-1Summary of EMDN 2025 Submissions and outcome of annual revisionApril 2026⌄
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MDCG 2021-12 rev.2FAQ on the European Medical Device Nomenclature (EMDN)April 2026⌄
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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⌄
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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⌄
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MDCG 2022-16Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746October 2022⌄
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MDCG 2025-9Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746Note: Pilot to roll-out the guidance is expected to be launched in Q2 2026December 2025⌄
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MDCG 2025-6FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)June 2025⌄
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InfographicIs your software a Medical Device?March 2021⌄
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MDCG 2019-11 rev.1Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746June 2025⌄
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MDCG 2021-17Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)July 2021⌄
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MDCG 2019-14Explanatory note on MDR codesDecember 2019⌄
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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⌄
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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⌄
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MDCG 2022-21Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745December 2022⌄
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MDCG 2021-5 rev.1Guidance on standardisation for medical devicesJuly 2024⌄
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MDCG 2018-1 rev.4Guidance on basic UDI-DI and changes to UDI-DIApril 2021⌄
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Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products
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Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC
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Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
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Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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