Market Surveillance Authorities, responsible Governmental Authorities, web pages areas of competence in the http://www.soi.sk http://www.nip.sk Public Health Authority of the http://www.uvzsr.sk Slovak version - http://www.uvzsr.sk/index.php?option=com_content &view=category&layout=blog&id=77&itemid=83 GPSD, toys, PPE (private use), construction products, eco-design, noise emission in the environment by equipment for use outdoors Machinery, PPE (professional use), pressure equipment, lifts, appliances burning gaseous fuels, ATEX, LVD Cosmetics, foodstuffs for particular nutritional purposes, as well as baby food, infant formulas, delicatessen, pastries, ice cream water, new food, radiation-treated foods tobacco products in service caterers English version http://www.uvzsr.sk/en/index.php/documents ns Office of the http://www.teleoff.gov.sk State Mining Authority http://www.hbu.sk Railways Transport Regulation Authority http://www.urzd.sk National Institute for Drug Control http://www.sukl.sk ns equipment facilities, which may be a source of electromagnetic interference Explosives pyrotechnical articles for civil use, exclusive technical equipment, machinery equipment for the production of explosives, non-rail mining machines used in the underground, respiration resuscitating apparatus, self-rescue apparatuses, fire extinguishers, etc. Cableway installations designed to carry persons, transportable pressure equipment Medical devices vigilance system according to EC Guidance Vigilance on medical devices http://www.sukl.sk/sk/zdravotnickepomocky/oznamy/sektorovy-narodny-programtrhoveho-dozoru-pre-zdravotnicke-pomocky-na-rok- 2010. Slovak Metrological http://www.smi.sk Slovak Environmental http://www.sizp.sk State Navigation Administration http://www.sps.sk Non-automatic weighs, medical devices, measuring instruments, gauges, prepackaged products State supervision of environmental aspects Recreational craft 1
State Energy http://www.sei.sk Energy efficiency n of the Labour, Social Affairs Family of the Health of the Environment of the http://www.economy.gov.sk http://www.telecom.gov.sk http://www.employment.gov.sk http://www.health.gov.sk http://www.enviro.gov.sk http://www.unms.sk http://www.unms.sk/?technicka-harmonizacia http://www.unms.sk/?free_movement_of_goods EU NA Directives, respective Governmental Ordinances SR, responsible Governmental Authorities responsible Market Surveillance Authorities in the Area covered by Directives of new approach EU on Technical requirements for products on conformity assessment Construction products No. of Directive Basic NA elements (transposition 93/465/EEC NA decision) as well as the framework for enforcement, including the safeguard clauses 89/106/EEC Gestor Construction Regional Development of the Slovak Interior of the Enforcement Act No. 254/2003 Act No. 90/1998 Act No. 413/2000 Act No. 134/2004 Act No. 173/2008 158/2004 Market Surveillance Authorities (Act No. 128/2002 ) State Fire Supervision, Interior SR (Act. No. 314/2001 17, 2
119/2006 Full text of the Law 69/2009 25) Machinery Lifts Noise emission in the environment by equipment for use outdoors Electrical equipment designed for use within certain voltage limits (LVD) Electromagnetic compatibility (EMC) 2006/42/EC 95/16/EC 2006/42/EC 2000/14/EC 2005/88/EC 2006/95/EC 2004/108/EC Labour, Social Affairs Family of the GO No. 436/2008 GO No. 571/2001 GO No. 327/2003 GO No.222/2002 GO No. 26/2006 Act No.254/2003 Act No.264/1999 GO No. 308/2004 GO No. 194//2005 (Act No. 128/2002 n Office of the Slovak Interior 3
of the Slovak Appliances burning gaseous fuels Pressure equipment Transportable pressure equipment 90/396/EEC 97/23/EC 99/36/EC 2001/2/EC 2002/50/EC Labour, Social Affairs Family of the (MTPT) GO No. 393/1999 GO No. 302/2002 GO No.252/2003 GO No. 148/2002 GO No.576/2002 GO No.329/2003 Act No.264/1999 Act No.254/2003 GO No.176/2003 Act No.254/2003 Act No.264/1999 Railways Transport Regulation Authority Transport of the MTPT SR Simple pressure vessels 87/404/EEC 90/488/EEC Interior of the Labour, Social Affairs Family of the GO No. 513/2001 GO No. 328/2003 State Fire Supervision, Interior SR 4
Efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels 92/42/EEC 2005/32/EC GO No. 79/2006 Act No.665/2007 Ecodesign of products Energy efficiency fluorescent lamps Energy efficiency requirements for household electric refrigerators, freezers combinations thereof Safety of toys (GPSD) Personal protective equipment 2009/125/ES 2005/32/EC 2008/28/EC 2000/55/EC 2005/32/EC 2008/28/EC Replaced by Commission Regulation 96/57/EC 2005/32/EC 2008/28/EC 88/378/EEC 2009/48/EC 89/686/EEC 93/95/EEC 96/58/EC Labour, Social Affairs Family of the Act No.665/2007 GO No. 79/2006 GO No. 594/2002 Act No. 254/1999 Act No. 436/2001 GO No. 425/2000 GO No. 295/2002 GO No. 253/2003 GO No. 302/2004 GO No. 35/2008 According to Act. No. 264/1999 5
Non-automatic weighing instruments Equipment protective systems intended for use in potentially explosive atmospheres (ATEX) Placing on the market supervision of explosives for civil uses Recreational craft Marine equipment 2009/23/EC 94/9/EC 93/15/EEC 94/25/EC 2003/44/EC 96/98/EC 98/85/EC 2001/53/EC 2002/75/EC 2002/84/EC 2008/67/EC 2009/26/EC Labour, Social Affairs Family of the GO No. 399/1999 GO No. 150/2002 GO No. 296/2002 GO No. 117/2001 GO No. 294/2002 GO No. 179/2001 GO No. 86/2006 GO No. 417/2004 GO No. 180/2001 Act No. 435/2000 GO No. 307/2002 GO No. 243/2001 GO No. 378/2004 GO No. 297/2009 GO No. 582/2006 Slovak Metrological State Mining Authority n s of the Slovak 6
Cableway installations designed to carry persons Trans-European high-speed rail system Interoperability of the trans-european conventional rail system 2000/9/EC 96/48/EC 2008/57/EC 2001/16/EC 2004/50/EC 2008/57/EC Act No. 97/2007 Act No. 581/2003 GO No. 581/2006 Communication No. 165/2001 GO No. 78/2004 GO No. 183/2002 718/2002 Act No.527/2003 Act No.71/1967 Act No.416/2001 Act No.95/2000 Act No.330/1996 Act No.260/2001 Act No.164/1996 Act No.254/2003 Act No.264/1999 Act No.513/2009 Act No.416/2001 Act No.513/2009 Act No.416/2001 (Act No. 128/2002 ) Railways Transport Regulation Authority Railways Transport Regulation Authority 7
Radio equipment telecommunicati ons terminal equipment the mutual recognition of their conformity Medical devices In vitro diagnostic medical devices Active 99/5/EC 93/42/EEC 98/79/EC 2000/70/EC 2001/104/EC 2007/47/EC 98/79/EC 90/385/EEC 93/42/EEC Health of the Slovak Health of the Slovak Health of the Slovak GO No. 443/2001 Act No. 610/2003 Act No. 140/1998 Act No. 488/2001 Act No. 270/2007 Act No. 489/2008 GO No. 582/2008 GO No. 527/2008 GO No. 569/2001 (in vitro) Act No. 140/1998 Act No. 488/2001 Act No. 270/2007 Act No. 489/2008 GO No. 572/2001 GO No. 582/2008 GO No. 569/2001 (in vitro) GO No. 527/2008 Self-Governing Region (Higher Territorial Unit) n Office of the State Institute for Drug Control State Institute for Drug Control 8
implantable medical devices Packaging packaging waste 2007/47/EC 94/62/EC 2004/12/EC 2005/20/EC Environment of the Slovak GO No. 569/2001 GO No. 570/2001 Act No. 488/2001 Act No. 489/2008 Act No. 140/1998 Act No. 270/2007 GO No.220/2005 210/2005 577/2003 5/2003 Act No.529/2002 State Institute for Drug Control Environment of the Pyrotechnic articles Measuring instruments directive (MID) MI-001 up to MI-010 Nominal quantities for prepacked products 2007/23/EC 2004/22/EC 2007/45/EC GO No. 485/2008 Act No.264/1999 Act No.254/2003 GO No. 295/2000 207/2000 420/2001 381/2008 GO No. 46/2009 Part of the foodstaffs programmes State Mining Authority Slovak Metrology Slovak Metrology 9
355/2004 538/2009 * GO - Governmental Ordinances SR 10