Stakeholder Landscape and Regulatory Implementation of Annex XVI Products in Finland: Oversight of Medical Devices Without an Intended Medical Purpose with Reference to the European Context

This thesis examines the implementation of Annex XVI of the Medical device regulation (EU) 2017/745 (MDR) in Finland. Annex XVI extends the MDR’s scope to include products without an intended medical purpose, such as dermal filler and intense pulsed light (IPL) devices, which have similar risk profiles and are now subject to comparable safety and surveillance requirements as medical devices. The aim of this study is to analyze the current market situation of Annex XVI products and identify the key stakeholders involved in the implementation in Finland, including Fimea, Tukes and STUK. The study explores how these actors interpret their roles and responsibilities under the MDR framework, what challenges they face in implementation, and how Finland’s approach compares with that of other European countries. The study employs a qualitative research design using semi-structured interviews, with participants from Fimea, Tukes and STUK, Norwegian and Austrian authorities and a Finnish plastic surgeon. Study findings reveal that the implementation of Annex XVI remains in progress, with overlapping responsibilities and limited resources posing key challenges. Stakeholders emphasised the need for clearer guidance from the European Commission, enhanced cooperation and communication between authorities to ensure effective enforcement. Additionally, improving professional users’ understanding and increasing awareness among consumers would further support compliance and safe product use. To conclude, effective implementation of Annex XVI requires improved inter-agency coordination, transparent communication, and targeted education for both professional users and consumers. Future research could examine the practical effects of these measures on compliance and safety outcomes within national and EU contexts.

Grantor dc:publisher

Helsingin yliopisto

Year dc:date.issued

2025

Author dc:creator

• Anttila, Sanni

• turvallisuus
• arviointi
• haastattelututkimus
• lääkinnälliset laitteet
• valvonta
• EU-direktiivit
• Annex XVI
• regulatory implementation
• Fillers
• Täyteaineet
• compliance challenges
• Fimea
• viranomaiset
• lainsäädäntö
• EU-maat
• Liite XVI
• täytäntöönpano

Statement dc:rights

• CC BY-NC-ND 4.0

Language dc:language.iso

eng

Handle dc:identifier.uri

http://hdl.handle.net/10138/625179

OAI identifier oai:identifier

oai:helda.helsinki.fi:10138/625179