The medical device design is controlled by the European Commission (CE) Directives in the European Union. Three main Directives of devices are categorized in the regulatory frame work. Council Directive 93/42/EEC relates to all medical devices, Council Directive 98/79/EC relates to in-vitro diagnostic devices and Directive 90/385/EEC to active implantable medical devices, respectively. Further amendments and regulations are mandated depending on the medical instruments intended operations, usability and electrical configurations.
All the global regulatory bodies follows that all the medical device needs to be classified according to similar categorization. There are three main categories of medical devices, Class I, Class II and Class III. In the EU, class II is further divided into IIa and IIb. Class I devices are not at all in contact with the human. The analysis is done from human substrate in a medical device, with the blood glucose meter as anH1 example of Class I medical devices. Class II devices are much more sophisticated and mainly using in diagnostics. It is in contact with the human and either modify the tissue or its functionality. Class III devices are high end devices which can save a human life and if it goes wrong it can kills also. It modify the human tissue and can be implanted into humans. The classification further mandates possible specific regulations, such as IEC 60601, namely that all medical devices with electronics need to comply with IEC 60601.
Two main quality management systems (QMS) in controlling and monitoring the medical device design are established for the companies developing them: 21CFR820 by the FDA (FDA 2013a), and ISO 13485 by the EU (ISO 13485). The QMS defines to different and various processes that the manufacturers concentrate and look into product development, manufacturing, marketing and after sales. Product design is other crucial factor which manufacturer mainly looks into. Risk management is also an high priority criteria for QMS to function properly. ISO 14971 is the standard quality system that regulates the risk management process globally. while implementing QMS this standard must be followed and implemented.
There are three directives put forward by European commission mainly for innovative approach and designed to protect consumers (patients) and to allow the cross border or free trading of goods. The new Approach Directives are based on the below mentioned principles; the products which only placed on the market are the ones which fulfilling the essential and important requirements and follow the directives. Manufacturers can choose any kind of solutions and up gradation of the products that also need to go along with directives and essential requirements. Medical Devices Directive which is considered as core of the legislation is best understood by the system. For getting the CE marking and other core ISO standards the quality management system is essential for a manufacturer at any cost. Not only CE marking but also for product design, production, risk management and marketing. QMS also can be categorized and adjust it levels depend on the categorization that supervision, level of control and the content of data to support the product.
CE mark for the low risk (category I) devices can be self-attested by the manufacturer itself. It can also done with a national competent authority system which is considered as self-certification. The national agencies (such as MDA) will check whether the requirements are fulfilled or not as per the directives. They do this through an audit programme. MDA will take important actions if requirements are not completed or if product is not certified with CE mark or the industry has not been registered yet.
For high-risk devices (class II and III) it is controlled and regulated through so called Notified or Conformity Assessment Bodies such as BSI (British Standards Institute) or companies supervised, audited and designated in each Member State of the European Union by the relevant Devices Agency (Competent Authority) of each country. Once the device got CE marking it can be start selling in all European union countries without further evaluation or controls. This is significantly different from the position for medicines. For example if an Italian Notified Body approves the device, then the manufacturer can promote and sale it immediately in the Germany, UK and any other EU countries. The Directives are followed by standards and by guidance documents.
However the regulation of medical device certification is carried out very unique in all EU but certain parameters such as coverage, reimbursement, and pricing – are made at the level of the individual EU member states (Table below).