Legislation

Polish law

Medical Devices Act of 20 May 2010 (OJ 2010 No. 107 item. 679.)

Regulation of the Minister of Health of 12 January 2011 on essential requirements and procedures for assessing the conformity of active implantable medical devices (OJ C 133, 11.12.2011, p. 1). 2011 No. 16 item. 74)

Regulation of the Minister of Health of 12 January 2011 on essential requirements and procedures for assessing the conformity of in vitro diagnostic medical devices (OJ C 104, 11.12.2011, p. 1). 2011 No. 16 item. 75)

Regulation of the Minister of Health of 12 January 2011 on essential requirements and procedures for assessing the conformity of medical devices (OJ C 104, 11.12.2011, p. 1). 2011 No. 16 item. 74)

Regulation of the Minister of Health of 15 November 2010 on the models of applications submitted in connection with a clinical trial, the level of application fees and the final report on the implementation of a clinical trial (OJ C 104, 11.12.2010, p. 1). 2010 No. 222 item. 1453)

Regulation of the Minister of Health of 5 November 2010 on the classification of medical devices (OJ C 104, 11.12.2010, p. 1). 2010 No. 215 item. 1416)

Regulation of the Minister of Health of 18 October 2010 on the manner in which notifications and notifications concerning devices are to be made (OJ C 133, 11.12.2010, p. 1). 2010 No. 202 item. 1341)

Regulation of the Minister of Health of 23 September 2010 on the model CE mark (OJ C 104, 11.12.2010, p. 1). 2010 No. 186 item. 1252)

Regulation of the Minister of Health of 22 September 2010 on the level of notification and notification fees for devices and the amount of the fee for applying for a certificate of free sale (OJ C 104, 11.12.2010, p. 1). 2010 No. 186 item. 1251)

REGULATION OF THE MINISTER OF HEALTH of 10 March 2011 on the detailed conditions to be met by the clinical evaluation of medical devices or active implantable medical devices (OJ C 104, 11.12.2011, p. 1). U. of 24 March 2011

Regulation of the Minister of Health of 2 February 2011 on criteria for reporting incidents with devices, how to report medical incidents and device safety activities (OJ C 104, 11.12.2011, p. 1). 2011 No. 33 item. 167)

European Union law

  • COUNCIL DIRECTIVE 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active deposition medical devices (AIMDD or AIMD);
  • COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 on medical devices (MDD);
  • DIRECTIVE 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (IVDMD or IVD);
  • Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market.
  • Commission Decision of 19 April 2010 on the European Database on Medical Devices (Eudamed).

Be the first to comment on "Legislation"

Leave a comment

Your email address will not be published.


*


*

Holler Box