Message 002
Communication from the Commission - TRIS/(2019) 03385
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2019/0601/D
No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.
(MSG: 201903385.EN)
1. MSG 002 IND 2019 0601 D EN 02-12-2019 D NOTIF
2. D
3A. Bundesministerium für Wirtschaft und Energie, Referat E B 2, 11019 Berlin,
Tel.: 0049-30-2014-6353, Fax: 0049-30-2014-5379, E-Mail: infonorm@bmwi.bund.de
3B. Ministerium für Soziales, Gesundheit, Jugend, Familie und Senioren, Referat VIII 403,
Adolf-Westphal-Straße 4, 24143 Kiel
Tel.: 0049 431 988-5447
Fax.: 0049 431 988-6185447
E-Mail: Anne.Marcic@sozmi.landsh.de
4. 2019/0601/D - C00C
5. Ordinance of the Ministry of Social Affairs, Health, Youth, Family and Senior Citizens of Schleswig-Holstein: State Ordinance on infection prevention in medical facilities (Medical Infection Prevention Ordinance - MedIpVO [Medizinische Infektionspräventionsverordnung - MedIpVO])
6. § 2(8) of the State Ordinance concerns biocidal products used as disinfectants in certain medical facilities.
7. -
8. Disinfectants used to protect people against infection with pathogens of communicable diseases in hospitals, preventive care or rehabilitation facilities with medical care comparable to that of hospitals, outpatient surgery facilities, dialysis facilities or day hospitals must be suitable for preventing infection at these facilities and proven to be effective in doing so. The (bacterial, viral, yeasticidal, tuberculocidal, mycobactericidal, fungicidal or sporicidal) efficacy required for each area of use must be documented by at least two independent test reports and associated expert reports. The test reports must meet requirements for the test methodology and must have been prepared by manufacturer-independent, accredited testing institutes. The test reports and export reports must have been scientifically evaluated by an independent commission of experts.
9. In facilities for the medical examination and treatment of patients, disinfection measures must be carried out. The use of potent disinfectants is imperative for the various applications in order to adequately protect patients against infections. The use of effective disinfectants can prevent the transmission of infectious agents via hands, medical devices and other materials as well as by a contaminated environment. In particular, the presence of resistant pathogens requires the use of reliably effective and appropriately tested disinfectants. Because antibiotic resistance makes it increasingly difficult to treat severe infections, it is even more important to prevent infections with these resistant pathogens from the outset. Because the mechanism of action of disinfection procedures differs from that of anti-infective agents and antibiotic resistance is not automatically associated with resistance to disinfection procedures, the use of disinfection procedures is an important tool for preventing infections, especially with resistant and multi-resistant pathogens.
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products also provides for an assessment of the effectiveness of biocidal products in the context of the approval. However, Regulation (EU) No 528/2012 is primarily aimed at avoiding unnecessary environmental risks and health risks for users of biocidal products. Ensuring that patients are protected from infections is thus outside the scope of the harmonised area. The special requirements to be placed on the effectiveness of disinfectants in order to protect patients in medical facilities are not satisfied by the effectiveness checks provided for in Regulation (EU) No 528/2012. The effectiveness of the biocidal products for use in infection protection is therefore ensured by requirements.
10. Restriction on the market placement of a chemical substance, preparation or product
Reference to the basic texts: MedIpVO: http://www.gesetze-rechtsprechung.sh.juris.de/jportal/?quelle=jlink&query=MedInfpV+SH&psml=bsshoprod.psml&max=true
11. No
12. -
13. No
14. No
15. -
16. TBT aspect
No - the draft has no significant impact on international trade.
SPS aspect
No - the draft has no significant impact on international trade.
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European Commission
Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu
