Medical Product Directive

Guideline of the Commission for Principles of Good Manufacturing Practice for Medical Products, Directive 91/356/EEC, 1991. 

Where there is a dosing device provided with the product, the dose reproducibility and accuracy should be demonstrated. Examples include dropper devices, dose-measuring devices, and pen injectors. The instructions for use should also be discussed for such devices and may be particularly important for devices such as two-chamber cartridges and the like containing suspension products. It might be necessary to discuss how dosing devices meet the relevant Essential Requirements of the Medical Device Directives with reference to appropriate and relevant harmonized and other European (EN) and International Standards Organization (ISO) standards. 

The basic structure, concepts and terminology of the three Directives on AlMDs, MDs and 1 VDs are identical the differences that exist among them arise out of the different nature of these products. The following discussion will therefore focus on the medical devices directive (MDD), since this is the central Directive and covers most products. Short sections follow on AlMDs and IVDs. Detailed analysis of the relevant provisions would fill a large book what is intended here is to highlight the important aspects which should be considered. 

Other obligations apply to distributors of consumer products. The GPS obligations apply in the absence of other specific rules of Community law governing the safety of such products. It is clear that the obligations under the medical device Directives cover most, if not all, producers obligations which arise under the GPS Directive as set out above. Manufacturers are... 

From a classification point of view, ocular endotamponades are classical medical devices. Their application inside the human eye requires, besides ultra-purity, special controls during the manufacturing as well as for the release of finished products. They must be non-toxic and sterile and have to meet the general requirements of the European Medical Device Directive (MDD). 

The Web sites on antidepressants appear to market the products directly to women, often without clear medical justification. 

In Europe, prior to the CE mark, medical devices were registered in individual countries, each having a set of specific registration requirements. In June 1993, the Council of European Communities issued the medical device directive (MDD), which has been transposed into national laws throughout the EC. The purpose of adoption of the MDD was to allow the health care industry to benefit from the advantages of a single European market and allow products to circulate freely in the EC without additional technical constraints issued by the various member states. 

Neither the FDC Act nor FDA s implementing regulations define the term switch, which typically refers to moving a drug product from Rx to OTC status. FDA will allow a switch when the prescription requirements are no longer necessary to protect the public health and the drug is safe and effective for use in self-medication as directed in the proposed OTC product labeling [89]. 

The efforts to develop a harmonized system concerning direct safety, efficacy, and quality go back to 1965, when the first harmonized directive was issued [95]. Ten years later, the Committee for Proprietary Medicinal Products (CPMP) was established [96]. In 1989, the International Conference on Flarmonization (ICFI) was founded, and the EMEA began operation on January 1,1995 [97]. The EMEA serves as an advisory board, but is responsible for coordinating the approval, manufacturing, and inspection of medical products between the CPMP and member states regulatory bodies [98]. 

DEHP exposure of humans might result from intravenous administration of blood that has been stored in plastic containers, or through hemodialysis. Under situations such as these, in which DEHP is introduced directly into the blood, it is possible to evaluate exposure by measuring blood DEHP concentrations. DEHP metabolites, MEHP and phthalic acid, are also measured in the blood to determine exposure from medical products or devices (Barry et al. 1989 Sjoberg and Bondesson 1985). If the total amount of phthalate is to be monitored, the phthalate esters are first de-esterified (Liss et al. 1985). Techniques that measure total phthalic acid are not specific for DEHP exposure since other alkyl phthalic acid esters that are used as plasticizers will also produce phthalic acid after de-esterification. 

EU directive 75/318/EEC (1989) Guideline Clinical Investigations of Medical Products in Children, March 1989... 

In order to more directly induce innovation for substitution, authorities have often created projects in cooperation with progressive manufacturers, main users, and universities, in order to develop proper substitutes. Examples include the Gron Kemi project in Southwest Sweden and which may be visited at http //www.gronkemi.nu/ start eng.html. Also, various initiatives to phase out lead and other substances from various product groups in the Danish Renere Produkter program may be consulted on OXFORD AS/IIIEE 2006. Several countries have initiated research programs that aim to phase out chemicals from medical products and other applications. 

EEC directives and guidelines as well as the volumes summarizing "The Rules governing Medical Products in the European Community" are available on sale from ... 

Alcohol has few direct medical uses but is an ingredient in several legitimate medical products. Alcohol s acute action is evident in a wide variety of physiological, sensorimotor, and behavioral effects. In... 

Drug samples shall be offered in conformity with the directives issued by the Medical Products Agency. 

This activity, established under the Medicines Act 1968, still remains wholly within the remit of national regulatory authorities but in accordance with Directive 92/25 EEC on the wholesale distribution of medical products for human use (Official Journal LI 13/1-4 30 April 1992). 

The interaction between CPMP (which reports to the Enterprise Directorate, formerly the Commissions DG m Industry Affairs) and the new Medical Products and Medical Devices Committee, which reports to the Health Directorate, formerly DG XXIV Consumer Policy, is very uncertain. It has to be borne in mind that the objective of Directive 65/65 was to advance the... 

The Medical Device Directive 93/42 defines medical devices and products, which combine a drug with a device. For regulatory purposes, the latter are subdivided and dealt with as follows ... 

The market size is 1700 million 70% of pharmaceutical products are purchased directly from pharmacies. Koreans prefer locally manufactured medical products over imported foreign drugs. Traditional therapeutic herbal products are still widely popular. This applies possibly to most of... 

Direct mail MedWatch The FDA medical products reporting program Food and Drag Administration 5600 Fishers Lane Rockville, MD 20852-9787... 

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