Clinical data is essentially the safety and performance information that is generated from the use of a medical device. To demonstrate safety and performance of a medical device, clinical evidence must be provided. Basically, there are two possibilities to generate clinical evidence. Firstly, clinical data may be collected through clinical investigations conducted with the respective medical device. The second possibility may be the demonstration of safety and performance based on data already publicly available. This could be data published in scientific literature or data for comparable devices through the literature route. In this scenario, demonstration of comparability and/or equivalence, respectively, is required. For example, this could be based on directly comparative bench tests and/or pre-clinical studies.
If applicable, both routes of clinical investigation and clinical evaluation via literature must be used in order to prove clinical safety and performance of a medical device before a device may be placed on the market.
PMCF (Post-market clinical follow-up) studies are part of the clinical post market vigilance system and are studies which have to be conducted (in addition to any pre-market activities) after the device has been placed onto the market.
Clinical Data generated through a PMCF study may only serve to confirm safety and performance. The objectives of such a study has to be covered by the scope for which the device is already approved, e.g. with regard to intended use and indications.
Moreover PMCF studies serve to generate data regarding complications and/or problems which may only become apparent after wide-spread or long term use of the device.
Clinical investigation for medical devices is any systematic investigation on one or more human subjects, undertaken to assess the safety or performance of a medical device.
Clinical investigations must be carried out in accordance with the Helsinki Declaration and in accordance with local regulations.
Clinical evaluation can utilise the following literature:
- Clinical investigation or other studies of a similar device reported in scientific literature
- Published and/or unpublished reports on other clinical experience of either the device in question or a similar device
As a new medical device is not the sum of its partial equivalences to different established products, it is essential to establish equivalency of both devices when establishing clinical safety and performance of a medical device via clinical data. This can be achieved by using published data on established devices, bench tests and in-vivo animal studies.
According to Annex 1.I.5a of directive 90/385/EEC (AIMDD) and Annex I.I.6a of directive 93/42/EEC (MDD), demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7/Annex X of the respective directive. It is also anticipated that the guidelines of MEDDEV 2.7.1 rev. 3 - Clinical Evaluation, part of a set of guidelines relating to questions of application of EU-Directives on Medical Devices, are likely to be followed by European Union member states, even though it is legally non binding.
Post-market clinical follow-up studies are conducted following the CE marking of a device and are intended to answer specific questions relating to clinical safety or performance of a device when used in accordance with its approved labelling.
Post-market clinical follow-up studies may be needed as rare complications or problems may only become apparent after wide-spread or long term use of the device. In addition, there may be limitations to the clinical data available in the pre-market phase. These include limited sample sizes, short duration of testing and heterogenous sample groups. It is important to note that data obtained from post-market clinical follow-up studies are not intended to replace the pre-market data necessary to demonstrate conformity with regulatory requirements.
The decision to conduct post-market clinical follow-up studies must be based on the identification of possible residual risks and/or the lack of clarity in long term clinical performance that may impact the benefit/risk ratio of a medical device.
Post-market clinical follow-up studies are mandatory for:
- Innovative medical device and products
- Medical devices used in high risk anatomical locations
- Medical devices affected by the emergence of new information on safety or performance
- Medical devices where the CE mark was issued based on equivalence
MEDDEV 2.12-2 rev. 2 - Post market clinical follow up studies, is part of a set of guidelines relating to questions of application of EU-Directives on Medical Devices. The guidelines are likely to be followed by European Union member states, even though it is legally non binding.
The document reflects positions taken by representatives of interest parties in the medical devices sector and serves as a guide for manufacturers and Notified Bodies on how to carry out post-market clinical follow-up studies in order to fulfil post-market surveillance obligations according to Medical Devices Directives (MDD).