CEFTA meeting on conformity assessment and mutual recognition 6-7th April 2003 – High Tatras Country Report - Hungary Albert Kálmán Head of Quality Unit Ministry of Economy and Transport József Tarcsi Certification Manager Hungarian Standards Institution

CHANGES

Main activities Legal harmonisation on the field of industrial products Governmental tasks of national standardisation Institution building Market surveillance, technical safety PECA Agreement Giving more information for the SMEs

Information campaign Booklet series/seminars for SME’s General knowledge on CE marking electrical safety (LVD) EMC GKM, ITDH, machinery MSZT, toys FVF gas appliances, hot water boilers Pressure equipment Medical devices

Information Expert groups for the Directives machinery, Gas appliances, EMC, Toys, LVD, Pressure equipment, ATEX Help Desk Function seminars, trainings, guidelines, information campaign - GKM, EuroInfo Centre, Chambers notified bodies market surveillance authorities

Regulations infrastructure

Where to find more information? Publication, literature, Guidelines Ministry Authorities Testing, certification bodies Standardisation body (MSZT) ITD Euro Info Centre internet

REVIEW OF THE NEW APPROACH DIRECTIVES IMPLEMENTED

Product safety PRODUCT Horizontal legislation New approach Directives CE marking Old approach Directives

Horizontal rules EU legislation 85/374/EEC product liability 92/59/EEC general product safety Hungarian legislation Act X. of 1993 on product liability Act CLV. of 1997 on consumer protection 79/1998. (IV.29.) Gov.decree

Horizontal rules 93/465/EEC Council Decision on conformity assessment moduls and of the conformity marking (Global Approach) 339/93/EEC regulation the import from third countries MSZ 25051:1996 (Hungarian standard) 208/1999. (XII.26.) Government decree on uniform conformity marking Gov. Decree, amendment of 79/1998. (IV.29.) Korm.r.

New approach Directives 73/23/EEC LVD 79/1997. (XII. 31.) IKIM 88/378/ EEC Toys 24/1998. (IV. 29.) IKIM-NM 89/336/ EEC EMC 31/1999. (VI.11.) GM-KHVM 90/396/ EEC Gas appliances 22/1998. (IV. 17.) IKIM 90/384/ EEC Non-automatic Weighing Instr. 19/1998. (IV. 17.) IKIM 92/42/ EEC Hot water boilers 20/1998. (IV. 17.) IKIM 98/37/EC Machinery 21/1998. (IV. 17.) IKIM 87/404/ EEC Simple pressure vessels 97/23/EC Pressure equipment 9/2001. (IV.5.) GM 99/36/EC Transportable pressure equipment /2003. ( ) GM 93/15/ EEC Explosive for civil use 191/2002.(IX.4.) Gov.decree 94/9/EC ATEX 8/2002. (II.16.) GM

New approach Directives 93/42/EECMedical devices and 90/385/EECActive Implant. m. d.47/1999. (X. 6.) EüM 89/686/EEC PPE2/1995. (I. 6.) EüM 94/25/EC Recreation crafts2/2000. (VII.26.) KöViM 95/16/ECLifts108/2001.(XII.26.) FVM-GM 89/106/EEC Construction products3/2003.(I.25.) BM-GKM-KvVM 99/5/ECR&TTE 3/2001. (I.31.) MeHVM

PECA Agreement Protocol to the European Conformity Assessment

PECA Agreement Ratification: Brüsszel Coming in to force: /2001. (V.30.) Governmental decree Conditions of the agreement: - full harmonisation of the relevant fields, - effective background institution-system

PECA sectors Machines Electrical safety (LVD) EMC Hot water boilers Gas appliances Medical devices GLP (good laboratory practice) GMP (good manufacturing practice)

Notified bodies MEEI – LVD, EMC, machines TÜV Rheinland Intercert – machines, LVD MBVTI – gas appliances, boilers ORKI – medical devices

PECA extension New partners – EEA countries New areas –PED –ATEX –toys (?) –R&TTE –Noise of outdoor machines