When is my IVD subject to PECP?
The IVDR 2017/746, and more specifically Article 48(6), defines that for risk class D devices, the Notified Body has to evaluate whether to consult with the expert panel on the performance evaluation report, provided by the manufacturer.
In order for the Notified Body to evaluate, there are conditions defined, which are:
- The absence of common specifications (CS) for the risk class D device under review
- where it is the first certification for that type of device.
what are common specifications?
The IVDR 2017/746 specifies in the opening text under (21), that the European Commission has the power to adopt common technical specifications for groups or categories of IVDs.
The CS are used specifically in areas where no harmonised standards exist or where they are insufficient. A manufacturer, complying to the established CS, will inherently comply with the general safety and performance requirements (GSPRs), the requirements for performance studies and performance evaluation and/or post-market follow-up.
Any CS will be published in the Official Journal of the European Union. Once published, the CS is understood to be “available” and no consultation under the PECP is necessary for that IVD.
How to determine the IVD class?
Annex VIII of the IVDR 2017/746 does provide the classification rules for IVDs.
Within a total of 7 Rules, the classification for any IVD can be derived thereof. The risk classes are divided into 4 levels, i.e. A, B, C, D, whereas A is of lowest risk and D of highest risk.
How is "first certification" defined?
Notified Bodies should consult with the MDCG where it is the first certification for that specific type of device and there is no similar device on the market having the same intended purpose and based on similar technology.
With this, Article 48(6) of the IVDR 2017/746 mentioning “first certification for that type of device” should be understood as the first certification under the former directive IVDD 98/79/EC or under the current regulation IVDR 2017/746 by any notified body in relation to a product with a specific intended purpose and specific analysis technology and process.
Who is the expert group?
The Expert Group is the Medical Device Coordination Group, short MDCG. The MDCG is implemented by the European Commission and is composed of persons designated by the Member States based on their role and
expertise in the field of medical devices under MDR 2017/745 including in vitro diagnostic medical devices under IVDR 2017/746.
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