European medical device

In the case of IVDs that require the involvement of a Notified Body, data on performance characteristics, the results of performance evaluation and device certificates issued by the Notified Body must be included in the submission. The Competent Authorities are responsible for entering the following information in a European medical device databank, EUDAMED ... 

This item very briefly sums up a recently-published report from EUCOMED (the European medical device industry trade association) on the use of ethylhexyl phthalate (DEHP) as a plasticiser in PVC medical products, and the risks associated therewith. 

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). 

European medical device requirements are defined in EU Directive 93/42/EEC published in 1994. National legislation and regulatory authorities such as the U.K. Medicines and Healthcare products Regulatory Authority (MHRA) enforce this directive. Four classes of device are defined, each of which requires a visible CE marking of conformity. CE marking of conformity means that the manufacturer is satisfied that the medical device conforms to relevant EU Directives and that it is fit for purpose. Technical documentation supporting conformity related to automated devices includes ... 

A number of regulators including those enforcing the European Medical Device Directive now prefer manufacturers to demonstrate conformity through compliance... 

The basis for the national or international standards (lEC, UL, VDE, MDD [the European Medical Device Directive]) is to reduce file risk of hazardous currents reaching the patient under normal conditions. Even under a single fault condition, patient safety shall be secured. 

The adoption of the European Medical Device Directive (MDD) in June of 1998 and the mandatory implementation of the CE label on all sterile medical devices marketed in the European Community have resulted in the compulsory use of expiration dates on all medical device packages. In Older to obtain the CE label, all the Essential Requirements of the directive must be met. The MDD states that the label must bear. . . where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and month. ... 

CE Mark. All medical textiles regarded as medical devices now placed on the market have to comply with the European Medical Devices Directive and bear the CE mark, demonstrating that they are fit for their intended purpose and meet the essential requirements of the Directive. If they are supplied sterile, then the manufacturer or suppher also needs to consult with a Notified Body. ... 

To define what we mean by a medical textile, it may be appropriate to use the same approach that has been established for a product qualifying as a medical device. Using this approach, n medical textile is defined as any textile product manufactured with the intention to be used to diagnose, prevent, monitor, treat or alleviate disease, to compensate an injury or handicap, to investigate, replace or modify the anatomy or a physiological process, or to control conception. This definition taken from the European Medical Device Directive (its U.S. counterpart is issued by the Food and Drug Association [FDA]) is made from a regulatory perspective and specifies what criteria medical devices need to fulfil to make them safe to use and make it possible to sort out... 

The European Medical Device Directive, http //ec.europa.eu/health/medical-devices/index en.htm. 

In response to ever-increasing innovation and development of medical textiles, medical textile performance testing is required during the manufacturing process. The test requirements developed by the European Medical Devices Directive are presented in this section. There are different classes of test methods and standards. However, the conformity with each test standard depends on the types and classes of the medical... 

Compliance Engineering Magazine Cosmetic/Personal Care Packaging European Medical Device Manufacturer Injection Molding Magazine... 

The pressure equipment directive was adopted by the European Parliament and the European Council in May 1997. It harmonises the national laws of the 15 Member States of the European Union relating to equipment subject to the pressure risk. That directive is one of the series of technical harmonisation directives such as for machinery, medical devices, simple pressure vessels, gas appliances and so on, which were foreseen by the Communities programme for the elimination of technical barriers to trade. It therefore aims to ensure the free placing on the market and putting into service of the equipment concerned within the European Union and the European Economic Area. At the same time it permits a flexible regulatory environment, allowing European industry to develop new techniques increasing thereby its international competitiveness. 

European Commission, Enterprise and Industry Directorate-General http //ec.europa.eu/enterprise/pharmaceuticals/index en.htm. http //ec.europa.eu/enterprise/medical devices/index en.htm. European Medicines Agency... 

The CE Mark is not specific to medical devices, but is used generally to indicate to European consumers that a product conforms to applicable European performance and safety requirements. It can be found on electrical equipment, children s toys and safety equipment, among other products. 

The responsibilities of Competent Authorities in terms of market vigilance are set out in the Articles of the device directives, whereas the obligations for manufacturers are contained in the Armexes. MEDDEV guide 2.12-1 provides detailed practical guidance on how the medical device vigilance system should operate within the EU, the European Economic Area (EEA) and Switzerland. This guidance was significantly... 

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. 

This presentation addresses tissue engineering and how it relates to biomaterials and medical devices. Consideration is given to risk analysis and risk management in tissue engineering, and current proposals are discussed for an approach to the regulation of tissue engineering products and regulatory processes in the European Union. EUROPEAN COMMUNITY EUROPEAN UNION UK WESTERN EUROPE... 

The debate over the use of soft PVC in medical devices continues. This article provides insights on the perspective of the medical device industry, and on the PVC industry s response to a Green Paper on PVC published by the European Commission in July 2000. We are also told that the Commission is committed to issuing a final communication on PVC in 2001. 6 refs. 

Medical grade plastics are discussed with reference to biocompatibility and the tests that the end-product manufacturer should perform in order to ensure the safety of the material. Regulatory requirements are described, and tabulated data is presented on mostly European suppliers of medical grade plastics. The data shows that most companies rely onUSP Class VI certificates to demonstrate the suitability of their materials for the medical industry. However, it is argued that most manufacturers of medical devices would benefit more from tests carried out according to ISO 10993. 6 refs. 

Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) (2007) Preliminary report on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk. European Commission, Health and Consumer Protection... 

Guidance is issued by the European Commission on medical device vigilance which includes an explanation of the difficult concept of when a deterioration in state of health should be considered serious ... 

---