The medical device design is controlled by the European Commission (CE) Directives in the European Union. The regulatory framework is categorized into three main Directives of devices. 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 device’s intended use, operating system and power output.
All the different regulatory bodies mandate that any 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 usually are not in contact with the human. The analysis is done from human substrate in a medical device, with the blood glucose meter as an example of Class I medical devices. Class II devices are in contact with the human and either modify the tissue or its functionality. Class III devices 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.
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 harmonized 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. The supervision, level of control and the content of data to support the product depend on the categorization.
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 appropriate enforcement action 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).medical device regulation