Regulatory Requirements

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Our divisions are in compliance with the listed requirements

Hospital Care

Legal basis in the area of quality management: The formal structure of the IMS manual is based on the recommendation of the international standards DIN EN ISO 9001:2008 and DIN EN ISO 13485. In terms of the content and informative value of the processes as demanded in the DIN EN ISO 9001:2008 and DIN EN ISO 13485 the “Integrated Management Systems" manual follows the following laws and standards:

  • DIN EN ISO 9001:2008 Quality management systems – requirements of the QM-presentation in design, development, production, assembly and maintenance
  • DIN EN ISO 13485: Quality Assurance Systems – medical devices
  • Directive 93/42/EWG of the Council for medical devices
  • 21 Code of Federal Regulations (CFR) 820 (US Federal Law)
  • Canadian Medical Devices Regulations (CMDR)
  • Japanese Pharmaceutical Affairs Law (J-PAL)
  • Taiwanese Pharmaceutical Affairs Law (Pal)
  • PIC-Guidelines for Good Manufacturing Practice for medicinal products
  • Guideline of a Good Laboratory Practice
  • Guideline of a Good Clinical Practice
  • Country-specific laws in Germany: Medical Product Law, The Drug Law, Plant regulation for pharmaceutical enterprises (insofar as they are applicable), Plant regulation for pharmaceutical wholesale companies
  • ICH-Guideline

Each of the laws and standards is taken into account in its currently valid version.

Connections with the relevant laws and regulations for environmental protection: As for as applicable for local production site the term “Industrial environmental protection“ describes all activities undertaken in connection with environment-compatible production, which are aimed at keeping the air clean, protecting the soil and water, waste prevention, -reduction, -recycling and -disposal, as well as the disposal of the products. It follows the following standards:

  • DIN EN ISO 14001: Environmental management system – specification with instructions for application
  • EMAS (as far as locally applicable)

The laws for the assurance of an environment-compatible production related to immission protection, water management and the recycling and waste management is to be adhered by each production site as far as applicable on national law basis. The immission protection may regulate the installation and operation of plants and machines with environmental impact, both with and without official approval requirement. The set guideline for the operation of such plants and machines is their compliance with state-of-the-art technology standards. Because of this, future developments must already be taken into consideration for the purchase of new plants and machines.

The water management may regulate the duties of waste water treatment and the protection of the groundwater. Technical safety standards as well as cleaning methods, or directives for the prevention of waste water before such water reaches the public sewer system, are therefore introduced and enforced. It may regulate, the protection of the soil and the groundwater during the handling of water-polluting substances.

The regulations covering wastes may regulate the proper avoidance, recycling and disposal of waste, from their production to their final disposal (e.g. waste deposit). 

Conditions laid down by the authorities in the field of environmental protection: The operation of plants and machines with official approval requirement and the implementation of environmental activities may be subject to official authorities reviews. These conditions are fixed for each production site in a tabular form in a site-specific environmental Statement as far as applicable. The plant executive personnel ensure the compliance with these conditions.

 

Aesculap AG 

US:

  • 21 Code of Federal Regulations (CFR) 820 Quality System Regulation (QSR) for Medical devices and related regulations, also known as FDA (Food and Drug Administration ) requirements

Canada:

  • Medical Device Regulations: Canadian Medical Devices Regulations (CMDR)

European Union:

  • EU directive 93/42/EEC Concerning medical devices
  • EU-directive 722/2012 EU Animal Tissue Regulations in Effect for Some Medical Devices
  • EU-directive 2002/96/EG Waste Electrical and Electronic Equipment
  • ISO 9001:2008 Quality management systems - Requirements
  • ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
  • ISO 14001:2004 Environmental management systems
  • OHSAS 18001:2007 Occupational Health and Safety Assessment Systems
  • ISO 50001:2011 Energy management systems
  • 1836/93 Community Eco-Management and Scheme

Related guidelines for Good Clinical Practice and Good Laboratory Practice as well as other national laws in Japan, Korea, Taiwan, Brazil etc.

 

B. Braun Avitum

US:

  • 21 Code of Federal Regulations (CFR) 820 Quality System Regulation (QSR) for Medical devices and related regulations, also known as FDA (Food and Drug Administration) requirements

Canada:

  • Medical Device Regulations 

European Union:

  • EU directive 93/42/EEC of the council concerning medical devices
  • ISO 9001 Quality management systems
  • ISO 13485 Medical devices - Quality management systems
  • ISO 14001 Environmental management systems
  • ISO 50001 Energy management systems
  • OHSAS 18001 Occupational health and safety management systems
  • IEC/TR 62653 Guideline for safe operation of medical equipment used for haemodialysis treatments

National laws and regulations for medical devices and medicinals in the countries where the products are distributed Standards for medical devices and medicinals for the extracorporeal blood treatment

 

OPM

  • DIN EN ISO 9001:2008 Quality management systems – Requirements of the QM-presentation in design, development, production, assembly and maintenance
  • DIN EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes 

Canada:

  • Canadian Medical Devices Regulations (CMDR) 

European Regulation:

  • EC Regulation 1935/2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC of 27th Oct. 2004
  • EC Regulation 1223/2009 on cosmetic products 

European Directives:

  • EMC Directive 2004/108/EC Electromagnetic Compatibility
  • 93/42/EC Medical Device Directive
  • 98/79/EC In Vitro Diagnostic Medical Devices
  • 98/8/ EC Biocidal Products
  • 2002/96/EC Waste Electrical and Electronic Equipment
  • 2002/95/EC Restriction of Hazardous Substances in Electrical and Electronic Equipment
  • 67/548/EEC Dangerous Substances
  • 89/686/EEC Personal Protective Equipment
  • 2013/C 68/01 Good Distribution Practice of Medicinal Products for Human Use 

German Laws:

  • AMG Medicines Act
  • BtMG Narcotics Act
  • MPG Medical Devices Directive
  • HWG Law on advertising in the field of healing being
  • KrWG Recycling Law
  • LFGB Foods, Commodities and Feed Code (01.09.2005)
  • ElektroG Act Governing the Sale, Return and Environmentally Sound Disposal of
  • Electrical and Electronic Equipment (Electrical and Electronic Equipment - WEEE)
  • ChemG Law on the Protection Against Hazardous Substances 

Regulation Medical Products:

  • MPG-KostVO Medical Products - Cost Regulation
  • DIMDIV DIMDI Regulation
  • MPV  Medical Products-Regulation
  • MPSV  Medical Product Safety Scheme Regulation
  • MPBetreibV Medical Products Operator Ordinance
  • MPVerschrV Regulation on the prescription of Medical Devices
  • MPVertrV Regulation on distribution channels for medical devices
  • MPKPV  Ordinance on Clinical Trials with Medical Devices 

Regulation Medicinal Products:

  • AMPreisV Drug price Regulation
  • AMHandelsV Regulation on the wholesale and drug agency
  • AMVV  Regulation on the prescription of Drugs
  • GCP-V  Regulation on the implementation of good Clinical practice in the conduct of clinical trials on medicinal products for Human use
  • AMGKostV AMG Cost Regulation
  • AMBezV Designation Regulation
  • AMG-EV AMG-filing Regulation
  • AMWarnV Drug Warning Regulation
  • AMVerkRV Regulation on pharmacy-only and non-prescription medicines
  • PackungsV Package Size Regulation
  • Cost for the admission of Medicinal products by the Federal Institute for Drugs and Medical Products and the Federal Office of Consumer Protection and Food Safety