Start considering whether the Medical Device Coordination Group (MDCG) or the International Medical Device Regulator Forum (IMDRF) have issued any guidance document that may impact your medical device.It is essential to identify these standards early on in the development of the product as some may contain specifications which can impact the design of the product. For example, compliance with ISO 13485 ensures the presence of a solid Quality Management System as required by the MDR and IVDR.Īs MDs and IVDs can range from a wide variety of technologies and therapeutic areas with very different requirements, manufacturers should ensure that harmonised standards and international guidelines applicable to the device of interest are used. Manufacturers of MDs and IVDs have some general guidelines and standards available to support them comply with the general safety and performance requirements (GSPRs) set out in Annex I of the regulations. Identification of applicable guidelines, GSPR and standards Note that most devices (except MDs Class I and IVDs Class A and B) require the involvement of a notified body to assess the conformity of the device with the above mention regulations. From lower to higher risk, MDs are classified into Class I, Class IIa, Class IIb and Class III, whereas IVDs are divided into Classes A to D. For example, factors such as the degree of invasiveness, the part of the body affected, time in contact with the body and whether or not the device is active are considered when classifying devices. Examples include medicinal products, personal protective equipment, or lifestyle software without a medical purpose.īy using the applicable regulations, every device is then classified according to its risk. Some products may initially seem to fit the MD or IVD definition, but further assessment can conclude that they are not devices. The product’s qualification consists of evaluating whether it falls under the EU Medical Device Regulation EU MDR 2017/745 (MDR) or the In vitro diagnostics medical device Regulation EU IVDR 2017/746 (IVDR), respectively. Once the product’s intended purpose is defined, the following steps include its qualification and classification. Note that the intended purpose must be consistent and present across all product documentation (technical documentation, clinical evaluation, labelling, instructions for use, promotion and sales material). The definition of the intended purpose will allow the device qualification (section 2) and classification (section 3). The intended purpose should be a concise statement (two to three sentences) that indicates the use for which the device is intended according to the manufacturer’s information.
Defining the intended purpose is crucial when planning the road to CE marking.
0 kommentar(er)
