Active Implantable Medical Devices Directive
Medical devices (as a whole) include any instrument, appliance, software, etc. used for the purpose of prevention (e.g. vaccine-delivery devices), screening (e.g. mammography for breast cancer), diagnosis (e.g. use ultrasound system) treatment, or alleviation of disease. Medical devices are currently regulated under three main Directives covering:
- Active Implantable Medical Devices (AIMD),
- Medical Devices (MDD)
- In Vitro Diagnostic Medical Devices (IVDD)
AIMD is classified as a device which must rely on a source not provided by the body or gravity and be designed to be introduced into the body with the intention to remain there following the procedure. The directive specifies that these products should meet essential safety requirements in terms of function, sterility, material compatibility, marking, user instructions and design documentation. In addition there are requirements for type approval, production quality management, clinical investigation and manufacturer registration.
The Directive: AIMDD 90/385/EEC
AIMDD (Active Implantable Medical Device Directive) 90/385/EEC has been in place since June 20, 1990. This directive applies to devices according to Article 2.C AIMDD, which defines an active implantable medical device as:
any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure” additionally the directive requires that all active implantable medical device manufacturers must affix CE-Marking to the Directive in order to place their devices on the European Market. The AIMDD 90/385/ EEC also mentions the language requirement issue in Article 4.4, “when a device is put into service, Member States may require the information described in sections 13, 14 and 15 of Annex I to be in their national language(s).
Path to EU Market Entry: Compliance
Demonstrating CE compliance with the AIMDD requires CE certification by a Notified Body, which involves some of the following:
- Essential Requirements
- General requirements (” The devices must be designed and manufactured in such a way, that their use does not compromise the clinical condition or the safety of patients.”)
- Requirements regarding design and construction
- Manufacturer appoints a European Authorized Representative (2007/47/EC Article 10a(2))
- CE Declaration of Conformity (Complete quality assurance system)
- Quality system
- Examination of the design of the product
- Administrative provisions (the declaration of conformity)
- EC Type- Examination
- Make an application for evaluation of quality system to a notified body (Annex III, section 3)
- EC verification
- EC Declaration of Conformity to Type
- Quality system
- Statement concerning devices intended for special purposes
- Clinical evaluation
- Clinical investigation (purpose, ethical consideration, methods)
- Minimum criteria to be met when designating inspection bodies to be notified
- Conformity of CE marking
Restrictions of Hazardous Substances Directive
The RoHS Directive 2011/65/EU that came in to force on the 21st July 2011 has placed a restriction on the use of certain substances in electrical and electronic equipment of manufactured products including medical devices. The RoHS Directive has listed substances and their percentage restrictions which will apply to all electrical and electronic equipment in Annex II of this Directive. From the 22rd July 2014, all electronic and electrical equipment contained in medical devices must comply with the restrictions established in this Directive.
Notified Bodies for Active Implantable Medical Devices
Notified Bodies are responsible for ensuring that all the active implantable medical devices brought to the EU Market are safe and compliant. They help the manufacturers by implementing conformity assessment procedures and granting conformity certificates.
Here are some expectations that a Notified Body must meet before being designated by the EU Authorities. Their main role is to review the technical documentations and approve the Design Dossiers for all AIMD. They decide whether or not to grant them EC-Design Examination Certificates.
Selecting the most suitable Notified Body for an active implantable medical device is vital. Manufacturers can choose a Notified Body from the European Commission´s complete directory of Notified Bodies who are accredited for CE marking of active implantable medical devices. It is available on the NANDO website and the list contains more than 60 Notified Bodies from 22 countries (including Turkey and Australia).
Selecting the right Notified Body for your Active Implantable Medical Devices can be a daunting task. Contact us to learn more about Obelis Notified Body Selection services to simplify and streamline the process.
New Regulation Proposal: 542/2012 Compliance
On April 2nd, 2014 the European Parliament adopted a resolution introducing 347 amendments to the European Commission’s proposal for a new Regulation on medical devices. This resolution introduces the amendments that were initially voted on 22 October 2013 on first reading of the Commission’s proposal.
In accordance with the co-decision procedure, the text is now under review of the Council for 1st reading. At this stage, 2 outcomes are possible:
- The Council may side with the Parliament’s position, in which case the legislative act will be adopted;
- The Council may amend the text adopted by the Parliament’s, and return the proposal to Parliament for a 2nd reading.
When the new text will be adopted, medical manufacturing companies will have to make sure they are in compliance with new CE marking requirements in order to lawfully affix the CE mark.
- Introductions of rules concerning the reprocessing of single use devices: all medical devices are to be considered reusable and suitable for reprocessing by default. Only devices that will be defined by the Commission as being ‘unsuitable for reprocessing’ may be single use.
- Involvement of the Special Notified Bodies in the conformity assessment procedures of high-risk devices (e.g. class III and implantable devices) that would be designated by the European Medicines Agency (EMA).
- Introduction of medical devices for aesthetic purposes within the scope of the proposal for a Regulation on medical devices.
- The Unique Device Identification system proposed by the Commission was endorsed by the Parliament.
- Introduction of a prior approval by competent authorities in order to prove conformity with general safety and performance requirements by other means than clinical data. The possibility to use non-clinical testing methods to prove conformity is restricted to low-risk devices.
It is still unsure whether the Council will support the above-mentioned points. Obelis, in its role of European Authorized Representative, is constantly watching legislative developments so as to make sure to provide medical manufacturing companies with the best advisory services on CE marking.
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