Medicintekniklagen

Reference

SFS 2021:600

In force

2021-07-15

Responsible authority

Läkemedelsverket

Area

Working life and health

EU legislation

Kompletterar förordning (EU) 2017/745 om medicintekniska produkter och förordning (EU) 2017/746 om medicintekniska produkter för in vitro-diagnostik

Read date

2026-08-16

• Read the act in the Swedish Code of StatutesSFS 2021:600
• Source page with preparatory works and regulations

• Prop. 2020/21:172Anpassningar till EU:s förordningar om medicinteknik

• Medical devices, quality management systems

  SS-EN ISO 13485:2016Svenska institutet för standarder (SIS)

  The quality management requirements for manufacturers and suppliers of medical devices: design, traceability, production, sterility and post-market action.

• Medical devices, application of risk management

  SS-EN ISO 14971:2019Svenska institutet för standarder (SIS)

  The method for risk management across the whole life cycle of a medical device: risk analysis, evaluation, reduction and follow-up of residual risk in clinical use.

• How many days of annual leave is an employee in Sweden entitled to?Annual Leave Act (1977:480) sections 4 and 12
• What does systematic work environment management require of a small employer?Work Environment Act (1977:1160) chapter 3 section 2 a, with the Work Environment Authority's provisions on systematic work environment management

Swedish Medical Products Agency

• Patientdatalagen · SFS 2008:355
• Patientsäkerhetslagen · SFS 2010:659
• Hälso- och sjukvårdslagen · SFS 2017:30
• Patientlagen · SFS 2014:821
• Läkemedelslagen · SFS 2015:315