The below mentioned principles; essential requirements are limited

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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 multiple
processes that the manufacturers follow in product development, manufacturing,
marketing and after sales. Other important factor in QMS is risk management
which is a high priority, it is strictly controlled and properly regulated in
the product design. Globally, ISO 14971 is the standard quality system that
regulates the risk management process. This standard must be complied to and
followed while implementing QMS.

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There are three
directives initiated by European commission which is based as an innovative
approach and designed to protect consumers (in this instance patients) and to
allow the free movement of goods. The new Approach Directives are based on the below
mentioned principles; essential requirements are limited by harmonization and
products which full filling the essential requirements are only placed on the
market. These standards or other specifications always remains voluntary and
manufacturers can choose any technical solution and up gradation that provides
compliance with the essential requirements. Medical Devices Directive which is
considered as core of the legislation is best understood by the system. The quality
system is needed and essential for the manufacturer to get CE marking and also
for design, marketing, production, release and for individual risk assessment. It’s
depend on the categorization that supervision, level of control and the content
of data to support the product.

The manufacturer is
allowed to affix a CE mark for the low risk (category I) devices and combines
and registers the product with a national competent authority system which is
considered as self-certification. The national agencies (such as MDA) will analyses
and understand through their inspection and audit programme that the
manufacturer has complied and fulfill with all the requirements. MDA will take immediate
and important actions if requirements are not met 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 has been granted a CE mark in one Member State,
it can be marketed in all the other European Member States without further
controls and no further evaluations. 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 underpinned 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).

Categories: Industry


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