Educated at:                 

Leicester College of Art and Technology, UK        Trondheim Technical University, Norway

Former occupation:                                                         

Special Adviser on Medical Devices at the Norwegian  Board of Health (NBH). NBH is the Competent Authority for Medical Devices in Norway

Experience:

National delegate to:             

European Commission Medical Devices Expert Group, including Sub Groups on Vigilance, on Surveillance of Notified Bodies and EUDAMED Steering Group

EFTA delegate to:            

Global Harmonization Task Force: Plenary, Study Group 2 on Vigilance and Study Group 4 on Auditing

National delegate to:             

CEN BTS3 Healthcare, ISO TC 210 Quality management and corresponding general aspects for medical devices - WG3

Lecturer at the PRAQ III Seminars in Central and Eastern Europe (Albania, Macedonia, Bosnia, Slovenia, Slovakia, Hungary, Lithuenia, Romania)

Member of the Project Council of the Global Medical Device Nomenclature

GMDN (Global Medical Device Nomenclature) is based on EN ISO 15225 Nomenclature – Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange. Some 70 people were involved in its development, notably from Europe, Japan and US.

Within all medical devices regulations a number of obligations are placed on the manufacturer. Authorities are faced with the task of  regulating manufacturers and their devices, and people are involved in trade with these devices, e.g., suppliers, before these devices finally are brought into use. Hence, as an assistance tool, there is a need for a common method for describing and identifying the device in question in an unambiguous manner.

The GMDN’s main content is a generic definition and a term suitable for each group of devices having a number of properties in common. These Groups, at present some 7.000, each have their own unique code assigned. The Generic Device Groups are placed into 12 Categories. Below the level of Generic Device Group the manufacturer operates with his Device Type identification.

The manufacturer will go through some kind of procedure before a device is allowed on the market. A standardised, well formulated generic description of the device, together with an appropriate term name, will facilitate necessary communication.

In the post marketing phase feedback from the users is an all important key factor for any vigilance system where information is collected and reacted upon. For trading purposes, including tendering procedures, the generic definition given in the GMDN is useful. With electronic trading these advantages will be obvious.

All parties involved with medical devices; be it manufacturers, regulators, conformity assessment bodies, traders, owners or users will all have a common interest in an unambiguous  classification, i.e. a definition and term, with each device. The obvious person to assign a device to its class is the manufacturer.