Differences between Australian & EU Medical Device Regulation.
Information | Understanding | Best Practice.
Overview.The Australian regulatory framework introduced in October 2002, has many similarities with that adopted by the European Union (EU). However, while similar, the two systems do have some differences.
Regulatory frameworks.Australia regulates medical devices under:
the Therapeutic Goods Act 1989 (the Act)
the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).EU Medical Device Regulation has multiple directives to cover medical devices, such as:
Medical Device Directive (MDD) 93/42/EEC
Active Implantable Medical Device Directive (AIMDD) 90/385/EEC.
EU Directive 2007/47/EC, introduced on 5 September 2007 in the European Parliament, made significant amendments to the MDD and AIMDD.
In vitro diagnostic devices.The regulatory frameworks for in vitro diagnostic devices (IVDs) are different in Australia and the EU. In the EU, IVDs are covered by the IVD Directive 98/79/EC. In Australia, IVDs are regulated as a subset of medical devices but have distinct regulatory requirements.
Australian sponsor and European authorized representative.In Australia, sponsors take responsibility for the import, supply, or export of a medical device. A sponsor must be a resident or carrying on business in Australia.
In the EU, if the manufacturer does not have a registered place of business in a member state, the manufacturer must designate a single authorized representative in the EU responsible for placing the devices on the market. The authorized representative has the mandate to act and be contacted in lieu of the manufacturer in relation to meeting the obligations imposed by the MDD or AIMDD for all classes of devices. The authorized representative must be identified in the labeling supplied with the device.
Please note: Directive 2007/47/EC clarifies that manufacturers outside the EU require a single authorized representative who is established in the EU.
Identification of sponsor and authorized representative.In Australia, the information provided with the medical device must allow both the sponsor and manufacturer to be identified. The sponsor’s name and address must be provided with the device in accordance with Regulation 10.2 of the Regulations and must be located either:
on the device itself, unless it is not appropriate or practicable to do so, or
on the packaging of the device, unless it is not appropriate or practicable to do so, or
in documents supplied with the device.In the EU, Essential Requirements require the manufacturer to place the name and address of either the person responsible or the authorized representative of the manufacturer or the importer established within the EU to be on the label or outer package or instructions for use.
Conformity assessment procedures.The EU and Australian conformity assessment procedures are closely aligned.
In the EU, manufacturers may need to engage a Notified Body to obtain conformity assessment certification. This certification is called CE Certification. Once this certification has been issued the manufacturer may affix the CE mark to their devices prior to supply.
Declarations of conformity.In the EU, manufacturers make a Declaration of Conformity (DoC) under the MDD or AIMDD. This is a formal statement signed by an authorized representative of the manufacturer. The DoC states that the device (including the name, type or model of the device) has been verified in accordance with the relevant conformity assessment procedure and meets the requirements of the MDD or AIMDD.
In Australia, the conformity assessment procedures require the manufacturer to make a DoC in accordance with the Australian legislative requirements. The Australian DoC:
is made under the relevant clause of Schedule 3 of the Regulations
states that the device (including the name, type or model of the device) has been verified in accordance with the relevant Australian conformity assessment procedure
includes the GMDN code and classification of the devices
indicates the Unique Product Identifier for each Class III and AIMD device.
Australian Register of Therapeutic Goods (ARTG) and CE marking.The ARTG is the register of information about therapeutic goods for human use that may be imported, supplied in or exported from Australia. All medical devices, including Class I, must be included in the ARTG before supply in Australia. There are limited exceptions to this requirement specified in the legislation, such as for experimental use.
In the EU, the manufacturer must affix the CE marking to medical devices prior to supply. CE marking or CE Certification alone does not authorize supply in Australia. The authorized representative of the manufacturer of Class I medical devices exported to the EU must register details with their EU Competent Authority. For higher class devices, the manufacturer’s Notified Body must register details of CE certificates with their designating Competent Authority. The EU Competent Authorities have a centralized data-bank to store and share the above information as well as data relating to certificates, data obtained in accordance with vigilance procedures and data related to clinical investigations, but is not used to control supply of product in the EU. The Directive 2007/47/EC requires the data-bank to be fully operational by 5 September 2012.
Global Medical Device Nomenclature (GMDN) system.GMDN codes may be used internationally by regulatory bodies as a nomenclature system to help identify medical devices.
In Australia, GMDN codes are included on all:
entries in the ARTG
Australian Declarations of Conformity.In the EU, the adoption of GMDN codes has not been implemented to the same extent as in Australia. CE certificates are sometimes issued by EU Notified Bodies without reference to GMDN codes.
There may be differences between the GMDN Agency code table database and the TGA code table database.
Retention of records.In Australia, the manufacturer must keep all manufacturing records for at least 5 years from the last date of manufacture or the lifetime of the device, whichever is longer. However, distribution records relating to Class AIMD, Class III or implantable Class IIb medical devices must be retained by the sponsor for inspection by the TGA for 10 years.
Similarly, the EU directives require the retention of manufacturing records for 5 years from the last date of manufacture or the lifetime of the device, whichever is longer. However, for implantable devices, records must be kept for at least 15 years from the last date of manufacture.
Please note: Directive 2007/47/EC introduces the requirement that manufacturing records of implantable devices must be kept for at least 15 years from the last date of manufacture.
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation.
- FDA Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- European Medical Device Regulations (MDR’s).
- Current Good Manufacturing Practices. QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
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