The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives. The letters ‘CE’ are an abbreviation of Conformité Européenne, French word for European conformity. The CE mark must be affixed to a product if it falls under the scope of ‘New Approach’ Directives of European union.

Without the CE marking, and thus without complying with the provisions of the Directives, the product may not be placed in the market or put into service in the fifteen member states of the European Union and Norway, Iceland and Liechtenstein. However, if the product meets the provisions of the applicable European Directives, and the CE mark is affixed to a product, these countries may not prohibit, restrict or impede the placing in the market or putting into service of the product.

The CE Mark is compulsory within the context of the application of EC New Approach Directives. Thus, CE marking can, be regarded as the product’s ‘trade passport’ for Europe.

Notified bodies are recognized organizations within Member States, which can certify conformity assessment on the basis of the New Approach Directives.

KEY DIRECTIVES

Machinery Safety – 98/37/EEC

All Machines in the European Economic Area (EEA) from January 1st 1995 must comply with the Machinery Directive and be safe. Also all components which are supplied separately to fulfill a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons.

EMC – 2004/108/EC

The EMC Directive applies to apparatus liable to cause electromagnetic disturbance or the performance of which is liable to be affected by such disturbance.

Low Voltage Equipment – 2006/95/EC

The Low Voltage Directive applies to all electrical equipment designed for use with a voltage rating between 50 and 1,000v for alternating current and between 75V and 1,500V for direct current. These voltage criteria define the scope of the directive rather than the limit at which you start applying the regulations (e.g. hazards in 12Vdc circuits of a 240Vac supplied computer are covered under the LVD).

Pressure Equipment – 97/23/EC

This directive covers equipments which affects equipment operating at a pressure greater than 0.5 bars, entered into force and is mandatory from May 2002.

Medical Devices General – 93/42/EEC

All medical products marketed in European Union must carry the CE Marking under Medical Device directive. There are essential requirements in the MDD (such as safety, efficacy and EMC), and products must meet all applicable requirements.

Construction Products Directive – 89/106/EEC

Construction Product means any products, which is produced for incorporation in a permanent manner in construction works, including both building and civil engineering works.

UKCA marking (UK Conformity Assessed marking) is the UK product marking requirement that will be needed for products being placed on the market in Great Britain (England, Scotland and Wales), substituting the EU requirements for CE Marking (CE marking will continue to be accepted in Northern Ireland). UKCA marking will indicate that a product placed on the Great Britain market meets the UKCA Marking requirements. UKCA marking was specified in the original ‘EU Exit’ UK Statutory Instruments, and for most products this is defined in UK Statutory Instrument 2019 No. 696 and amendments (exceptions being Automotive, Marine and Medical devices for example).

The Central Drugs Standard Control Organisation(CDSCO) under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India. Its headquarter is located at FDA Bhawan, Kotla Road, New Delhi 110002 and also has six zonal offices,four sub zonal offices,thirteen Port offices and seven laboratories spread across the country.

The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics.It envisages uniform implementation of the provisions of the Act & Rules made there under for ensuring the safety, rights and well being of the patients by regulating the drugs and cosmetics. CDSCO is constantly thriving upon to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.

Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

About ISO 13485:

ISO 13485:2016 is that the commonplace for a top quality Management System (“QMS”) for the planning and manufacture of Medical Devices. Certification to the quality needs associate degree organization’s quality management system to pass a third-party Medical Device Single program, or “MDSAP” Audit. For the foremost part: ISO 13485 = ISO 9001 + further Medical Device necessities.
While ISO 13485:2016 remains a complete document, it aligns with ISO 9001:2008. (Yes, 2008, not 2015.) this can be as a result of it doesn’t follow the high-level structure (Annex L) of the most recent version of ISO 9001 (which is 9001:2015). additionally, the documentation and safety necessities square measure a lot of larger underneath ISO 13485:2016, whereas ISO 9001:2015 puts target client satisfaction and continuous improvement.
This international commonplace is obligatory in some countries, and within the U.S. the authority has planned a rule which might harmonize U.S. authority twenty one CFR 820 with ISO 13485:2016, creating ISO 13485 the FDA’s obligatory QMS for Medical Devices (the rule is predicted to be discharged in 2019).