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Virtual Tour

MEDiLEX is an interactive reference tool that acts as a single source for all the latest information on EU legislation in the fields of medical equipment and in vitro diagnostic devices. It provides all the relevant documents in one tool.
The concept of MEDiLEX is that of an interactive loose-leaf binder. What sets MEDiLEX apart from printed works is its network structure. The individual documents are interconnected with numerous cross-references. With an integrated full-text search, MEDiLEX enables you to locate quickly and accurately the passages and terms which are important for you. Tedious searching is a thing of the past.
Order your MEDiLEX license today! There is no risk: if you are not won over by MEDiLEX, you can return the goods within 4 weeks to get your money back!

 

Headline:

European Union legislative procedure

  • MEDiLEX-Europaeische Richtlinien 1
  • MEDiLEX-Europaeische Richtlinien 2
  • MEDiLEX-Europaeische Richtlinien 3
  • MEDiLEX-Europaeische Richtlinien 4
  • MEDiLEX-Europaeische Richtlinien 5
  • MEDiLEX-Europaeische Richtlinien 6
  • MEDiLEX-Europaeische Richtlinien 7
  • MEDiLEX-Europaeische Richtlinien 8

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices is one of three EU directives on medical equipment and is referred to in Germany and Austria for short as the Medical Device Directive. International one speaks of the directive as Medical Device Directive (MDD), or Directive 93/42/EEC. It is the most important regulatory instrument for proof of safety and medical-technical performance of medical devices in the European Economic Area.
Furthermore, there are numerous other important European policies which concern the manufacturers of medical equipment and IVD that are available in MEDiLEX, clearly laid out and in full text. In addition, here you will also find current decisions, recommendations, resolutions, and implementation rulings which affect you as a manufacturer.

Headline:

European implementation of directives on medical equipment

  • MEDiLEX-Europaeische Umsetzungen 1
  • MEDiLEX-Europaeische Umsetzungen 2
  • MEDiLEX-Europaeische Umsetzungen 3
  • MEDiLEX-Europaeische Umsetzungen 4
  • MEDiLEX-Europaeische Umsetzungen 5
  • MEDiLEX-Europaeische Umsetzungen 7

In every country in the European Union and associated countries, these European directives are implemented through national laws. This means that laws on medical equipment include qualitative regulations. In Germany and Austria, this is through the Medical Devices Directive (Medizinproduktegesetz, MPG).
Switzerland, although not a member of either the EU or the EEA, has the Therapeutic Products Act (Heilmittelgesetz), which leans heavily on the EU directives.
MEDiLEX includes the European implementations for Austria and Switzerland as well as the relevant agreements and regulations in full text and interactively linked.

Headline:

German law

  • MEDiLEX-Deutsche Gesetze 1
  • MEDiLEX-Deutsche Gesetze 2
  • MEDiLEX-Deutsche Gesetze 6
  • MEDiLEX-Deutsche Gesetze 3
  • MEDiLEX-Deutsche Gesetze 4
  • MEDiLEX-Deutsche Gesetze 5
  • MEDiLEX-Deutsche Gesetze 7

In Germany, the Medical Devices Directive (Medizinproduktegesetz, MPG) covers the national implementation of European Directives 90/385/EEC on active implantable medical devices, Directive 93/42/EEC for medical devices and Directive 98/79/EC on in vitro diagnostic devices. It includes the technical, medical and information requirements for the marketing of medical equipment (through manufacture or import) in the European Economic Area (EEA).
Furthermore, manufacturers of medical equipment are subject, depending on the product, to numerous other legal provisions, such as the Medicines Act, the Chemicals Act, the Genetic Diagnostics Act, the Law on Electromagnetic Compatibility of Equipment, the Product Liability Act, and/or the Product Safety Act.

Headline:

Provisions of the Medical Devices Directive

  • MEDiLEX-Verodnungen zum MPG 1
  • MEDiLEX-Verodnungen zum MPG 2
  • MEDiLEX-Verodnungen zum MPG 3
  • MEDiLEX-Verodnungen zum MPG 4

The Installation, Operation and Application of Medical Devices Act (Medizinprodukte-Betreiberverordnung – MPBetreibV) is based on the statutory authorization of § 37 para 5 of the Medical Devices Directive (Medizinproduktegesetz, MPG). It regulates the installation, operation, application, and maintenance of medical equipment in accordance with § 3 of the MDD and is the national regulatory framework for all professional installers, users and operators of medical devices.
Alongside this ordinance of the Medical Devices Directive, MEDiLEX also includes the following additional legal regulations in full text:

  • The Medical Fee Ordinance (BKostV-MPG)
  • The Medical Devices Conformity Assessment Regulation (MPKV)
  • The Medical Device Clinical Trials Regulation (MPKPV)
  • The Medical Devices Safety Plan Regulation (MPSV)
  • The Medical Devices Ordinance (MPV)
  • The Prescription Regulation (MPVerschrV)
  • The Regulation On Distribution Channels For Medical Devices (MPVertrV)

 

Headline:

Other acts and standards

  • MEDiLEX-Sonstige Verordnungen 1
  • MEDiLEX-Sonstige Verordnungen 2
  • MEDiLEX-Sonstige Verordnungen 3
  • MEDiLEX-Sonstige Verordnungen 4
  • MEDiLEX-Sonstige Verordnungen 5

In addition to the direct statutory instruments to Medical Devices Directive, MEDiLEX includes over one hundred other regulations that are relevant to you as a manufacturer of medical equipment (the full list is enumerated below). Also, a detailed list of changes accompanies each regulation, in which you can see at which time the changes were implemented. This allows you to pick out very quickly whether the current changes have an impact on the regulatory requirements concerning you, and act accordingly.

The Wastewater Act (AbwV)
AtKostV - The Cost Provision of the Atomic Energy Act
The General Administrative Regulation to § 40 para. 2, § 95 para. 3 of the Radiation Protection Ordinance and § 35 para. 2 of the X-ray Ordinance (AVV radiation passport)
AwSV - The Provision on Systems for Handling Water-Polluting Substances
The General Administrative Regulation on the Procedure for Official Supervision of the Observance of the Principles of Good Laboratory Practice (GLP-ChemVwV)
The Display Provision of the Medicines Act (AMG-AV)
The Cost Provision of the Medicines Act (AMGKostV)
The Requirements for the Design, Features and Operation of Decentralized Disinfectant Dosing: Directive of the Federal Institute for Materials Research and Testing, the Robert Koch Institute and the Commission for Hospital Hygiene and Infection Prevention
The Occupational Safety and Health Provision on Artificial Optical Radiation (OStrV)
The Medicines Directive (AM-RL) Directive of the Federal Joint Committee on the Regulation of Drugs in Statutory Health Care
The Transmissible Spongiform Encephalopathy Provision of the Medicines Act
The Coloring Provision of the Medicines Act (AMFarbV)
The Hardship Provision of the Medicines Act (AMHV)
The Benefit Assessment Provision of the Medicines Act (AM NutzenV)
The Price Provision of the Medicines Act (AMPreisV)
The Provision on Pharmacy-Only and Non-Prescription Medicines (AMVerkRV)
The Medicines Prescription Provision (AMVV)
The Pharmaceutical and Drug Manufacture Provision (AMWHV)
The Nuclear Waste Shipment Provision (AtAV)
The Narcotics Cost Provision (BtMKostV)
The Narcotics Prescription Provision (BtMVV)
The Domestic Market Animal Health Protection Provision (BmTierSSchV)
4. BImSchV - The Provision on Installations Requiring Approval
The Biological Material Deposition Provision (BioMatHintV)
The Biological Agents Provision (BioStoffV)
The Biocide Notification Provision (ChemBiozidMeldeV)
The Biocide Authorization Provision (ChemBiozidZulV)
The Blood Stem Cell Facilities Register Provision (BERV) <revision>
The Federal Cost Provision of the Genetic Engineering Act (BGenTGKostV)
The Climate Protection Provision of the Chemicals Act (ChemKlimaschutzV)
The Costs Provision of the Chemicals Act (ChemKostV)
The Penalties and Fines Provision of the Chemicals Act (ChemStrOWiV)
The Prohibition Provision of the Chemicals Act (ChemVerbotsV)
Introductory Guidance on the CLP Regulation
The DIMDI Provision (DIMDIV)
DIMDI AMV - The DIMDI Provision of the Medicines Act on the Database-Supported Information System for Drugs of the German Institute for Medical Documentation and Information
The Implementation of the X-ray Provision
The Calibration Provision
The Waste Electrical and Electronic Equipment Act Cost Provision (ElektroGKostV)
ElektroStoffV - The EEE Substances Provision
The Units Provision (EinhV)
The Technical Qualification Directive Technique in accordance with the X-ray Provision
The Hazardous Substances Provision (GefStoffV)
The Cost Provision of the Report of the Genetic Diagnostics Committee in accordance with the Genetic Diagnostic Act (GenDKKostV)
The Consultation Provision of the Genetic Engineering Act (GenTAnhV)
The Records Provision of the Genetic Engineering Act (GenTAufzV)
The Stakes Provision of the Genetic Engineering Act (GenTBetV)
The Emergency Provision of the Genetic Engineering Act (GenTNotfV)
The Safety Provision of the Genetic Engineering Act (GenTSV)
The Procedures Provision of the Genetic Engineering Act (GenTVfV)
GFK - The Common International Questionnaire for Proficiency Examination in accordance with § 5 of the Chemicals Prohibition Ordinance <revised>
The Hemotherapy Guidelines for the Collection of Blood and Blood Components and for the Use of Blood Products
The Cosmetics Provision
The Cost Provision for Official Duties of the Paul-Ehrlich-Institut pursuant to the Medicinal Products Act
The Cost Provision for Official Acts according to the Law on Electromagnetic Compatibility of Devices (EMVKostV)
The Cost Provision for the Registration of Homeopathic Medicinal Products by the Federal Institute for Drugs and Medical Devices and the Federal Office of Consumer Protection and Food Safety
The Cost Provision of the Stem Cell Act (StZG-KOSTV)
The Hospital Remuneration Act (KHEntgG)
The Hospital Financing Act (KHG)
The Early Cancer Detection Directive
The Guidelines for Metrological Controls of Medical Devices with Measuring Functionality (LMKM)
The Guidelines for the Biological Agents Provision (LASI publication 23)
The List of Treatment Substances and Disinfection Procedures in accordance with § 11 of the German Drinking Water Provision 2001 - May 2012 Status
MPGVwV - The Medical Devices Implementation Regulation: General Administrative Regulation for the Implementation of the Medical Device Directive
The Medical Device Provision (MedGV)
The Communication from the Commission for Hospital Hygiene and Infection Prevention
Mm-R - The Minimum Quantity Regulations: The Regulations of the Federal Joint Committee in accordance with § 137 paragraph 3 sentence 1 number 2 SGB V for Hospitals Approved under § 108 SGB V
The Package Size Provision (PackungsV)
The Care Statistics Provision (PflegeStatV)
Preimplantation Diagnostic Provision (PIDV): The Provision on the Regulations for Preimplantation Diagnostics
The Testing Instructions for the Implementation of the Supplementary Testing Positions according EPQC 4th Edition for Digital Mammography Systems
The Quality Assessment Directive: The Radiology directive of the Federal Joint Committee on Criteria for Quality Assessment in Diagnostic Radiology
rl_qsd - The Dialysis Quality Assurance Directive: Directive to ensure the quality of dialysis treatments according to §§ 136 and 137 paragraph 1 No. 1 of the Fifth Book of the Social Code (SGB V)
QS-RL - The Quality Assurance Directive in accordance with the X-ray Provision
The Guidelines of the German Medical Association for Quality Assurance in Immunohematology
The Guidelines of the German Medical Association for Quality Assurance in Microbiology (Parts A and B)
The Guideline of the German Medical Association for Quality Assurance in Quantitative Medical Laboratory Studies
The Guideline of Physical Radiation Protection Control for Determination of Body Doses Part 1: Determination of Body Dose from Exposure to External Radiation
The Guidelines for Monitoring Radiation Exposure at Work in accordance with Part 3, Chapter 2 of the Radiation Protection Provision
The Directive of the Federal Joint Committee on the Regulation of Drugs in Statutory Health Care
The Guidelines on Artificial Insemination: the Guidelines of the Federal Committee of Physicians and Health Insurers on medical measures for artificial insemination
The Guidelines for Promotion of Molecular Diagnostics
The Guidelines for Promotion of "Innovative Therapies on a Molecular and Cellular Basis"
The X-Ray Provision (RöV)
The Signature Provision (SigV)
The Implementation of the X-Ray and Radiation Protection Provisions - Measurement of Personal Dosage with Electronic Personal Dosimeters in Pulsed Fields
The Radiation Protection Provision (StrlSchV)
The Radiation Protection Provision (StrlSchV), as amended in 1989
SV RL - The Directive for Technical Examination of X-Ray Equipment and Sources of Stray Radiation Requiring a License
The Tattooing Provision
The Therapy Allergens Provision
The Transfusion Act Notification Provision (TFGMV): the Provision on Registration pursuant to §§ 21 and 22 of the Transfusion Act
The Provision on Notifiable Animal Diseases
The Provision on Requirements for Quality and Safety of Tissue Removal and Transfer according to the Transplantation Act (TPG Tissue Provision - TPG GeWV)
The Provision on Fees under the Electromagnetic Compatibility of Devices Act (EMVBeitrV)
<Amendments>
The Provision on Implementation of Good Clinical Practice in the Conduct of Clinical Trials of Medicinal Products for Human Use (GCP-V)
The Central Commission for Biological Safety Provision (ZKBSV)
The Provision on the Tissue Facilities Register in accordance with the Transplantation Act
The Provision Prohibiting the Use of Substances Contaminated with Aflatoxins in the Manufacture of Medicines
The Provision Banning the Use of Ethylene Oxide in Medicinal Products
The Provision on Notifiable Animal Diseases
The Provision on Quality and Safety of Organs: the provision on the requirements for organ and donor characterization and for the transport of organs, as well as the requirements for reporting serious adverse events and serious adverse reactions (TPG OrganV)
The Provision on Radioactive Drugs or Drugs Treated with Ionizing Radiation (AMRadV)
The Provision on Substances with Pharmacological Effect (PharmStV)
The Provision on Test Measures for the Introduction of Electronic Health Cards
The Provision to Protect against Foot-and-Mouth Disease (FMDV)
The Provision Amending the Jurisdiction of the Paul-Ehrlich-Institut
The Provision on Occupational Health Care (ArbMedVV)
The Provision Extending the Regulations Concerning the Authorization and Official Batch Testing of Test Sera and Test Antigens
The Provision Determining the Appropriate Administrative Authority for the Prosecution and Punishment of Offenses under § 23 para. 1 nos. 2, 4, 8, and 9 of the Waste Electrical and Electronic Equipment Act (ElektroGOWiZustV)
The Provision on the Central Ethics Committee for Stem Cell Research, and on the Appropriate Authority according to the Stem Cell Act (ZESV)
The Packaging Provision (VerpackV)
The Supply Medicine Provision (VersMedV)
Contracts in accordance with § 12 of the Transplantation Act

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