Med-info Guidance Documents
Click on the links below to download and view our 'Med-Info' Guidance literature.
Our services at a glance
Medical and Health Services [ PDF 384 kB ]
Providing Success on Global Markets
Directives / Design Dossiers
Med-Info EN60601-1 Third edition [ PDF 76 kB ]
MDD RL 93/42/EWG [ PDF 120 kB ]
Practice-oriented summary of the most important aspects and requirements.
MDD 93/42/EEC - Essential Requirement 7.5 [ PDF 81 kB ]
Carcinogenic, Mutagenic & Reprotoxic Substances (e.g. DEHP)
MDD revised
[ PDF 93 kB ] A survey of essential modifications.
MEDDEV [ PDF 112 kB ]
Practice-oriented summary of the most important aspects and requirements.
IVD RL 98/79/EG [ PDF 90 kB ]
Practice-oriented summary of the most important aspects and requirements.
EN 60601-1-2:2001 [ PDF 77 kB ]
Info about the generic standard for electromagnetic compatibility for medical electrical equipment with tips how to upgrade.
EN 60601-1: 3rd edition [ PDF 76 kB ]
Meanwhile a third edition of 60601-1-2 has been published as an IEC version dated quartal 3-2007. The new version is only an adaption to IEC 60601-1:3rd edition correcting failures.
2005/50/EG Reclassification of Joint Implants [ PDF 75 kB ]
Activities and schedule resulting from the reclassification of joint implants for hips, knees and shoulders.
Design Dossiers [ PDF 79 kB ]
Information about the content of Design Dossiers (technical files for class III devices that are comprehensively examined by the Notified Body).
Forms and requirements
[ PDF 77 kB ] Extension of EC Certificates - Detailed requirements for Clinical Data to be submitted.
Standards for Product Usability [ PDF 75 kB ]
Standards IEC 60601-1-6 and IEC 62366 regarding product usability - what is it all about and what are the advantages for manufacturers of medical devices.
Clinical Department
Clinical Reports acc. to MEDDEV 2.7.1 [ PDF 78 kB ]
Items and aspects that have to be checked or reflected in detail.
Clinical Affairs - Requirements for clinical data [ PDF 76 kB ]
Hints which are generally checked during an in-house review of a clinical report are based on our experience with documentations submitted in the past; they give additional advice for the demands outlined in the MEDDEV.
Clinical Data requirements for EC certificate extension
[ PDF 59 kB ] Description of the process for the extension of certifications validity of EC certificates acc. to AIMDD, MDD and IVD.
Animal Origin [ PDF 73 kB ]
Useful advice how manufacturers of medical devices can prepare themselves for the requirements laid down in for medical devices utilizing tissues of animal origin.
Information Required [ PDF 81 kB ]
Assessment of Medical Devices incorporating material of animal origin - information required by TÜV Product Service as the Notified Body (NB).
Human blood derivatives [ PDF 73 kB ]
Consultation of Medical devices combined with human blood derivatives
TSE certificates of suitability [ PDF 75 kB ]
Medical devices utilizing material of animal origin – the value of transmissible spongiform encephalopathy (TSE) certificates of suitability (EDQM certificates)
Biological safety on all levels [ PDF 74 kB ]
with emphasis on virus inactivation/elimination (EN 12442-3:2000). Bulletin compiles information on the documentation to be provided to demonstrate compliance with part three of the standard.
Tools for tissue engineering
[ PDF 101 kB ] The Directive 2006/86/EC asks for some special requirements with regard to the equipment utilized for the handling of cells.
Market Authorization of Combined Advanced Therapy Medicinal Products
[ PDF 104 kB ] Combinations of Advanced Therapy Medicinal Products with medical devices represent a new type of combination products requiring a fundamentally new approach for market authorization.
International Markets
Globalization of Medical Device Approval [ PDF 89 kB ]
How far are we along the path to the globalization of medical device approval. Information about the current situation in the EU and other important markets.
Market Access USA and Canada (NRTL & FES) [ PDF 168 kB ]
Ensure that you meet the requirements for medical device market approval in the US and Canada.
The Japanese Pharmaceutical Affairs Law [ PDF 78 kB ]
Practice-oriented summary of the most important aspects and requirements contained in Japanese PAL and related ordinances.
More services
Cooperation for Hygiene [ PDF 91 kB ]
Safety for patients and the users of medical devices! To achieve this target, a main focus on hygienic aspects is required. TÜV Product Service together with the German Association for Hospital Hygiene (DGKH) combine their expertise by granting a combined test mark.
Quality Management in Dialysis [ PDF 88 kB ]
The service provision in the health sector requires quality and transparency. It is foreseeable that the reimbursement for treatments will be linked to the fulfilment of defined quality criteria – as it has already been implemented in Germany and other countries. Tenders often demand a QM certificate.
ElektroG - Deadlines and Obligations for Manufacturers of Medical Products [ PDF 99 kB ]
Information on the implementation of the Electrical and Electronic Equipment Act (ElektroG) for manufacturers of medical products
EN 60601-2-5 [ PDF 82 kB ]
Due to the special characteristics of therapeutic ultrasound devices, additional safety aspects beyond the requirements of EN 60601-1 have to be observed. These special require ments are laid down in EN 60601-2-5. This Med-Info outlines the requirements of EN 60601-2-5 for therapeutic ultrasound devices.
EN 60601-2-37 [ PDF 81 kB ]
Due to the special characteristics of diagnostic ultrasound devices, additional safety aspects beyond the requirements of EN 60601-1 have to be observed. The special requirements resulting from this are laid down in the EN 60601-2-37 standard. This Med-Info outlines the requirements of EN 60601-2-37 for diagnostic ultrasound devices.
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