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Notified Body
A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations. A manufacturer can use voluntarily European harmonised standards to demonstrate that a product complies with some (or all) of the EU essential requirements; alternatively, a notified body assess the conformity to these essential requirements. Conformity assessment can include inspection and examination of a product, its design, and the manufacturing environment and processes associated with it. For example, a notified body may designate that a medical device conforms to the essential requirements of the Medical Devices Regulation (MDR (EU) 2017/745) which defines the applicable legislation, including the general safety and performance requirements, for medical de ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Conformité Européenne (logo)
On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA), but is also found on products sold elsewhere that have been manufactured to EEA standards. The mark indicates that the product may be traded freely in any part of the European Economic Area, regardless of its country of origin. It consists of the CE logo and, if applicable, the four digit identification number of the notified body involved in the conformity assessment procedure. "CE" is the abbreviation of ( French for "European conformity"). Meaning The mark on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant EU legislation and the product may be sold anywhere in the European Economic Area ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Breast Implant
A breast implant is a prosthesis used to change the size, shape, and contour of a person's breast. In reconstructive plastic surgery, breast implants can be placed to restore a natural looking breast following a mastectomy, to correct congenital defects and deformities of the chest wall or, cosmetically, to enlarge the appearance of the breast through breast augmentation surgery. Complications of implants may include breast pain, rashes, skin changes, infection, rupture, cosmetic changes to the breasts such as asymmetry and hardness, and a fluid collection around the breast. The most serious complication is a type of lymphoma (cancer of the immune system) known as Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). There are four general types of breast implants, defined by their filler material: saline solution, silicone gel, structured and composite filler. The saline implant has an elastomer silicone shell filled with sterile saline solution during surge ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation In The European Union
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For example: * in biology, gene regulation and metabolic regulation allow living organisms to adapt to their environment and maintain homeostasis; * in government, typically regulation means stipulations of the delegated legislation which is drafted by subject-matter experts to enforce primary legislation; * in business, industry self-regulation occurs through self-regulatory organizations and trade associations which allow industries to set and enforce rules with less government involvement; and, * in psychology, self-regulation theory is the study of how individuals regulate their thoughts and behaviors to reach goals. Social Regulation in the social, political, psychological, and economic domains can take many forms: legal restrictions ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Deutsches Institut Für Bautechnik
Deutsches Institut für Bautechnik (DIBt) is a technical authority in the construction sector. The Institute carries out its activities on the basis of an agreement concluded between the Federation and the German federal states (Länder). Its most important task is the approval of non-regulated construction products and construction techniques. The Institute is based in Berlin. Fields of activity Deutsches Institut für Bautechnik's fields of activity are: * grants national technical approvals (''allgemeine bauaufsichtliche Zulassungen'') for construction products and construction techniques. * issues European Technical Assessments (ETAs) for construction products in accordance with the Construction Products Regulation (Regulation (EU) No 305/2011). * draws up the Construction Products Lists (''Bauregellisten'') A and B as well as List C, and publishes them on behalf of the German federal states (''Länder''). The Construction Products Lists A and B contain officially recog ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation (EU) 2017/745
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021. The regulation was published on 5 April 2017 and came into force on 25 May 2017. Originally approved medical devices will have a transition time of three years (until 26 May 2021) to meet new requirements. Changes Changes compared to the Medical Device Directive include changes in device classification and device scope, stricter oversight of manufacturers by Notified Bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC) and of the economic operator concept, the requirement of Unique Device Identification marking for devices, EUDAMED registration (see below), UDI requirements, and increased post-market surveillance activities. Scope and classificatio ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Litigation
- A lawsuit is a proceeding by a party or parties against another in the civil court of law. The archaic term "suit in law" is found in only a small number of laws still in effect today. The term "lawsuit" is used in reference to a civil action brought by a plaintiff (a party who claims to have incurred loss as a result of a defendant's actions) requests a legal remedy or equitable remedy from a court. The defendant is required to respond to the plaintiff's complaint. If the plaintiff is successful, judgment is in the plaintiff's favor, and a variety of court orders may be issued to enforce a right, award damages, or impose a temporary or permanent injunction to prevent an act or compel an act. A declaratory judgment may be issued to prevent future legal disputes. A lawsuit may involve dispute resolution of private law issues between individuals, business entities or non-profit organizations. A lawsuit may also enable the state to be treated as if it were a private party i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Court Of Justice Of The European Union
The Court of Justice of the European Union (CJEU) (french: Cour de justice de l'Union européenne or "''CJUE''"; Latin: Curia) is the Judiciary, judicial branch of the European Union (EU). Seated in the Kirchberg, Luxembourg, Kirchberg quarter of Luxembourg City, Luxembourg, this EU institution consists of two separate courts: the European Court of Justice, Court of Justice and the General Court (European Union), General Court. From 2005 to 2016 it also contained the European Union Civil Service Tribunal, Civil Service Tribunal. It has a ''sui generis'' court system, meaning ’of its own kind’, and is a supranational institution. The CJEU is the chief judicial authority of the European Union and oversees the uniform application and interpretation of European Union law, in co-operation with the national judiciary of the member states. The CJEU also resolves legal disputes between national governments and EU institutions, and may take action against EU institutions on behalf ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Restitution
The law of restitution is the law of gains-based recovery, in which a court orders the defendant to ''give up'' their gains to the claimant. It should be contrasted with the law of compensation, the law of loss-based recovery, in which a court orders the defendant to ''pay'' the claimant for their loss. Evolving Meaning ''American Jurisprudence'' 2d edition notes: Legal vs Equitable Remedy Restitution may be either a legal remedy or an equitable remedy, "depend ngupon the basis for the plaintiff's claim and the nature of the underlying remedies sought". Generally, restitution and equitable tracing is an equitable remedy when the money or property wrongfully in the possession of defendant is traceable (i.e., can be tied to "particular funds or property"). In such a case, restitution comes in the form of a constructive trust or equitable lien. Where the particular property at issue cannot be particularly identified, restitution is a legal remedy. This occurs, for example ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Traceability
Traceability is the capability to trace something. In some cases, it is interpreted as the ability to verify the history, location, or application of an item by means of documented recorded identification. Other common definitions include the capability (and implementation) of keeping track of a given set or type of information to a given degree, or the ability to chronologically interrelate uniquely identifiable entities in a way that is verifiable. Traceability is applicable to measurement, supply chain, software development, healthcare and security. Measurement The term ''measurement traceability'' is used to refer to an unbroken chain of comparisons relating an instrument's measurements to a known standard. Calibration to a traceable standard can be used to determine an instrument's bias, precision, and accuracy. It may also be used to show a chain of custody - from current interpretation of evidence to the actual evidence in a legal context, or history of handling of any info ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Grade Silicone
Medical grade silicones are silicones tested for biocompatibility and are appropriate to be used for medical applications. In the United States, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regulates devices implanted into the body. It does not regulate materials other than certain dental materials. The FDA regulate silicones used in food contact under the auspices of the Center for Food Safety and Nutrition (CFSAN) and for use in pharmaceuticals under the auspices of the Center for Drug Evaluation and Research (CDER). Medical grade silicones are generally grouped into three categories: non implantable, short term implantable, and long-term implantable. Materials approved as Class V and VI can be considered medical grade. Most medical grade silicones are at least Class VI certified. Silicone suppliers and some silicone prototyping companies provide guidelines for material use. Uses *Tubing * Drains *Feeding tubes *Catheters *Implants ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Silicone Gel
A silicone or polysiloxane is a polymer made up of siloxane (−R2Si−O−SiR2−, where R = organic group). They are typically colorless oils or rubber-like substances. Silicones are used in sealants, adhesives, lubricants, medicine, cooking utensils, thermal insulation, and electrical insulation. Some common forms include silicone oil, silicone grease, silicone rubber, silicone resin, and silicone caulk. Chemistry More precisely called polymerized siloxanes or polysiloxanes, silicones consist of an inorganic silicon–oxygen backbone chain (⋯−Si−O−Si−O−Si−O−⋯) with two organic groups attached to each silicon center. Commonly, the organic groups are methyl. The materials can be cyclic or polymeric. By varying the −Si−O− chain lengths, side groups, and crosslinking, silicones can be synthesized with a wide variety of properties and compositions. They can vary in consistency from liquid to gel to rubber to hard plastic. The most common siloxane i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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