Clinical Evaluation Of Microcurrent Devices
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Clinical Evaluation of Medical Devices
Manufacturers of Medical Devices are clinically obliged to Evaluate Them
The Medical Devices Directive 93/42 EEC calls for The basic requirements For All medical devices in the European market to be met. It does not Matter whether this Product has already been introduced to the Market or is about to be Introduced. As Part of the Conformity Assessment Process, Manufacturers must comply with Annex X of the Directive And assess whether their Medical Device is. The Statements made about this Product are fulfilled. (Clinical Evaluation) Here, of course, the “Purpose of the Product” plays a decisive role, but not the Sole Ones. What is very often forgotten is that Advertising Statements on Flyers, Websites and Brochures are also included here and the Statements made have to be evaluated on them.
An Assessment with Significance
Before we come to the Content of the clinical Evaluation, I would like to explain at this Point the Scope of the clinical Evaluation. As Part of the Conformity Monitoring process , a so-called “technical documentation” is thus produced, for example, in the case of electric-medical products. The clinical Evaluation (other not to be confused with the clinical Trial!) is part of this technical Documentation and without this Component the Medical Device cannot be provided with a CE mark and is therefore not marketable For the European Market! So Should not be used on the Patient.
However, the clinical Evaluation is not just a Document that is produced and then disappears in the “P” Shelf and is no longer looked at, NO, it must be constantly monitored and reviewed by the Manufacturer in the so-called “Post-marketsurveillance” . The technical Documentation consists of a lot of Parts or Chapters, which interact with each other in an active Intertwining and interacting with each other. What does that mean? For example, if the Manufacturer has to evaluate the possible Risks, in the risk management Also prescribed, then of course the clinical Evaluation of the Medical Device plays into it.
What is the Goal of clinical Evaluation?
The Aim of the clinical Evaluation is quite simple at first Glance. It serves to ensure that the medical Devices on the European Market also fulfil a clinical proven Benefit and not only the Benefit for the Manufacturer to increase sales Figures. What further means that Manufacturers can also be careful with the Statements (especially Advertising) here. These Statements must be examined and documented in the Context of the clinical Evaluation for their actual Benefit.
Furthermore, as Part of the clinical Evaluation by the Manufacturer, it is necessary to ensure that there are no unexpected or unacceptable Side effects. Here, of course, risk management comes into Play, as already described Above!
Composition of clinical Evaluation
As the Name suggests, the clinical Evaluation is based on clinical Data. This Data is therefore Literature data or the Manufacturer already has a Predecessor (Equivalent device), a device comparable In effect to the Market. The Data of the Application of the Previous Device can and should, of course, be included in the Evaluation.
The designated Bodies such as the TÜV or the DEKRA (these check the technical documentation) presuppose that various Stellen/literary bodies are considered in the Course of the clinical Evaluation:
- Results from clinical Trials
- FDA Notifications of Problems with comparable Devices
- Feedback from the Market When comparable Devices are already Used
- And, of course, Notifications from The BfArM
Microcurrent Devices are usually IIa Risk-class Medical Devices. The ZLG, The CENTRAL Agency of The Countries for Health Protection in Pharmaceuticals and Medical Devices, has now ‘ applied ‘ to the designated bodies also for Medical Devices of the Risk class IIa The clinical Evaluation of the Manufacturers for Testing. For this, however, the designated Bodies must keep Specialist Personnel in From Doctors in the Company!! That’s quite a Challenge, not least for Manufacturers.
What does it mean if the clinical Evaluation is tested by, for example, the TÜV?
For Manufacturers, it means, first And foremost, adjusting to long Waiting times. Long Waits can mean 6 Months and more. And just for clinical Evaluation!!
For the designated Bodies, it means that You have to hire Doctors to meet the REQUIREMENTS of the ZLG. But where is the Matter interesting for the Manufacturers of Microstorming Devices?
Quite simply: All Those who have not yet lost their attention to quality Management and any Tests will definitely get one on the Lid and will probably be able to close the Gates in the near Future! We find this Right thing, because Quality Management, Safety and proof of Effectiveness are simply indispensable!
If the Device or Procedure has no Studies
However, If there are no Studies or scientifically accepted Work on the field of application or on the Statements of the Medical Device, the Manufacturer must carry out a clinical Trial! That means he needs to do a Study on the Statements. However, this is bound by very strict legal Regulations, because if there is no Literature on the Product or procedure yet, then there is no clinical Evaluation and therefore no CE mark!!
Regulatory Requirements for clinical Evaluation
There are a Variety of Documents, Standards and Guidelines that describe or dictate the Requirements for a clinical Evaluation.
Join The goals:
- § 19 MPG (Medical Devices Act)
- Annex X Of the MDD Medical Products Directive MDD 93/42/EEC
- The MEDDEV 2.7.1 Revision 4
As mentioned before, it gets really interesting if they don’t have any clinical Data themselves to create them! Here, the Legislature has built in very high Hurdles to Protect the Patient. Such as Section 20 of the Medical Devices Act And various other Regulations.
Be sure this Review is officially reviewed
The designated Bodies, as well as the Supervisory authorities, are becoming increasingly “stronger” in terms of controls and Reviews, especially in the clinical Evaluation. The Probability is very high that a Class IIa Medical Device will also be reviewed here in the near Future.
With the MDR, Regulation (EU) on Medical Devices 2017/745 everything will be different
The Publication of the Regulation (EU) on Medical Devices 2017/745 puts the clinical Evaluation in a completely different Light. Now it is finally clear what the Significance of this Assessment is for Manufacturers.