National enforcement authorities

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 ... 

While enforcement authority for informed consents exists in the FDA and in other non-US national and regional health authorities, the enforcement agency responsible for HIPAA in the US is the Office of Civil Rights (OCR) within the Department of Health and Human Services (HHS). Monitoring of HIPAA will likely occur by the Office of the Inspector General. 

The National Rivers Authority (NRA) enforces quality standards in surface waters. In order to ensure water quality, the NRA may prohibit the use of certain chemicals. The NRA can also establish Water Protection Zones , where certain activities are prohibited. 

CLEEN is a network of national chemicals inspectorates that coordinates and improves the enforcement of EU chemicals legislation (enforcement is the responsibility of the Member States). Is central task is the exchange of information between national enforcement authorities and it sets, in collaboration with the Member States, priorities for enforcement projects in the EU. 

EU medicines legislation has two broad aims - protection of public health and the creation of a single market for pharmaceuticals. EU legislation is initially proposed by the European Commission, goes through consultative and political processes and emerges via the European Parliament to be put into force by the Commission. In principle, if there is an apparent conflict with any national legislation, EU law takes precedence. However, this does not necessarily mean that national authorities cannot enforce additional requirements in their own territory. 

Presumption of conformity is a phrase associated with products that comply with all aspects of the relevant European harmonized standards. National enforcement authorities are obliged to recognize that equipment manufacmred in conformity with the harmonized standards, published in the Official Journal and transposed into national standards, are presumed to conform to the essential requirements of the directives. When a product is not in compliance with the appropriate European standards, the equipment will not benefit from a presumption of conformity conferred by the use of such standards. 

For most products and machines, the self-declaration process (module A) is possible. In practice the manufacturer performs the complete product assessment according to EU standards, issues the declaration, and affixes the CE marking to the product. A technical file or documentation must also be available on demand for national enforcement authorities. Keep in mind that this is an internal self-assessment process, a do-it-yourself approach, that results in issuance of the manufacturer s declaration of conformity and the CE marking (Figure 2-6). The buyer may demand proof of safety/EMC compliance in the form of a mark, certificate, or test report from a European notified or competent body. 

The technical file is for market surveillance purposes and must be kept at the disposal of national enforcement authorities. The documentation must be readily available to a duly substantiated request by enforcement authorities for inspection and control purposes. Failure to make the documentation available may constitute sufficient grounds for doubting the presumption of conformity. It is the manufacturers or their authorized representative in Europe who are ultimately responsible for the accuracy of the technical file. The technical files accuracy and the product safety/EMC conformity are of paramount importance. 

National enforcement authorities are obliged to recognize that products in conformity with harmonized standards ( EN listed in OJEC) and transposed into national standards are presumed to conform to the ERs of the directives. 

When a product becomes suspect the national enforcement authority will typically use the EN or equivalent national standards (usually with the help of a notified body) to evaluate the product s conformity or lack thereof. Taking any route other than the harmonized standards approach may work against diose who do not conform with the recognized standards, since compliance with these standards is universally recognized and expected by the enforcement authorities, notified bodies, and customers. 

European notified bodies (safety) and competent bodies (EMC) are accredited at the national level by the member states, such as in Germany at the European level accreditation occurs when notified to the Commission and listed in the Official Journal of the European Communities. These accredited bodies are sanctioned by the European Commission and the member states to interpret directives and standards, and issue test reports and certificates on conformity. When a product becomes suspect or an incident occurs, the national enforcement authority may consider a test report or certificate issued by a European body. Having the notified body mark, certificate, and test report usually shifts the onus of proof in the manufacturer s favor, since the product was evaluated and certified by European recognized experts. 

National enforcement authorities may consider marks, with report, as defense of due diligence. ... 

No Approval Mark or Certificate for potential customers and national enforcement authorities. 

A questionable product may come to the attention of the enforcement authorities by way of a customs inspection, market surveillance audit, user complaint, competitor, or incident. In any case, the national enforcement authorities rely on either the harmonized standards or their national transposed standards to assess the suspect products conformity or lack thereof. 

In the United States, the EPA pubUshes recommended national water quality effluent discharge criteria for the protection of aquatic life and human health, and is authorized to enforce compliance against these criteria under the Clean Water Act. States can elect to develop their own state-specific water quality criteria that are equal to, or more restrictive than, the EPA values. If a state elects not to institute its own state-specific standards then the EPA will promulgate standards for the state. The EPA s recommended water quality criteria are based on the highest concentration of a pollutant that is not expected to pose a significant risk to the majority of species in a given environment, and cover approximately 150 pollutants (EPA, 2014). The EPA criteria address total solids, aluminum, and copper, but do not specifically address alumina, ceria, or silica particles. 

Code Administration The American Society of Mechanical Engineers has written the ASME Boiler and Pressure Vessel Code, which contains rirles for the design, fabrication, and inspection of boilers and pressure vessels. The ASME Code is an American National Standard. Most states in the United States and all Canadian provinces have passed legislation which makes the ASME Code or certain parts of it their legal requirement. Orrly a few jurisdictions have adopted the code for all vessels. The others apply it to certain types of vessels or to boilers. States employ inspectors (usually under a chief boiler inspector) to enforce code provisions. The authorities also depend a great deal on insurance company inspectors to see that boilers and pressure vessels are maintained in a safe condition. 

Inspection Authority The National Board of Boiler and Pressure Vessel Inspectors is composed of the chief inspectors of states and municipalities in the United States and Canadian provinces which have made any pari of the Boiler and Pressure Vessel Code a legal requirement. This board promotes uniform enforcement of boiler and pressure-vessel rules. One of the board s imporiant activities is providing examinations for, and commissioning of, inspectors. Inspeciors so qualified and employed by an insurance company state, municipality, or Canadian province may inspect a pressure vessel and permit it to be stamped ASME—NB (National Board). An inspector employed by a vessel user may authorize the use of only the ASME stamp. The ASME Code Committee authorizes fabricators to use the various ASME stamps. The stamps, however, may be apphed to a vessel only with the approval of the inspector. 

This section covers only the tests that are essential on a completed motor, irrespective of the manufacturing procedure and stage quality checks. If ISO 9000 guidelines are assimilated, practised and enforced by a manufacturer so that a customer s trust is obtained, a final pre-despatch inspection by the customer may not be necessary. The customer, having gained confidence in the practices and Quality Assurance Systems of the manufacturer, may issue an authorization to the manufacturer to despatch the material under their own inspection certificate, rather than an inspection by the customer. We discuss below the test requirements procedure and the acceptance norms prescribed by various national and international standards for such machines and adopted by various manufacturers. 

Member states have a number of actions under the Directive. They have to appoint a competent authority (or authorities), transpose the Directive into national law, enforce it and provide information to the European Commission. 

Enforcement authority through police or National Guard... 

Crawshaw, T. Pre-Congress Workshop SETAC Effluent Toxicity Program, Implementation, Compliance and Enforcement National Rivers Authority (NRA) Worthing, West Sussex, UK, March 28, 1993. SETAC, Lissabon 1993. 

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