Frequently Asked Questions

Since 14 June 1998, the CE marking is mandatory for any medical device. To be entitled to label your product with the CE marking, you have to ensure conformity of your product with the directive 93/42/EEC (Medical Device Directive). This means that your product has to conform to the basic requirements specified by this directive. This includes technical documentation of the product. To view the contents required by the directive, simply visit our download center.

The exact steps for CE marking depend on the type of medical device, its classification. Explaining the different versions would be going too far at this point. Just call us and we will be happy to answer your questions.

This directive is applicable to active implantable medical devices. Thus, this directive covers any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.

These devices may be placed on the market and put into service only if they do not compromise the safety and health of the patient, the users, or, where applicable, third persons when properly implanted, maintained, and used in accordance with their intended purposes.

To read the full version of the directive, click here.

Risk analysis is one of the first steps when developing a medical device. With one or several FMEAs (failure mode and effect analysis), the risks of the medical device are analyzed and evaluated. However, FMEA merely constitutes one part of the risk management process according to EN ISO 14971.

We support you with every aspect of risk management throughout the life cycle of your medical device, e. g. by preparing and executing the FMEA, by providing the risk management report, and by implementing technical solutions to minimize the risks in terms of integrated safety.

Just contact us! We look forward to getting to know you!

On 21 March 2010, the transition period for DIN EN ISO 62366 (Application of usability engineering to medical devices) expired. According to 60601-1-6, originally only applicable to medical electrical equipment, this standard is now mandatory for all medical devices. This means that when developing a medical device, a usability engineering process needs to be installed and documented in a usability engineering file.

The usability assessment has by now become an integral part of medical device development. Together with our partners in this field we offer optimized solutions for implementing the usability process in your product development.

According to Section 19 (1) of the Act on Medical Devices, “evidence of the suitability of medical devices for the specified intended purpose shall be provided through a clinical evaluation based on clinical data [...]. The clinical evaluation [...] must be based on

data from scientific literature which cover the intended use of the medical device and the techniques involved in its use, as well as a written report containing a critical evaluation of these data, or
the results of all performance evaluation studies or other appropriate tests.”

It must be observed, however, that 1 only applies to the development of comparable medical devices and that all innovative products, therefore, require clinical investigation (as under 2) which implies that technical documentation according to MPKPV is essential.

Section 20 of the Act on Medical Devices defines the prerequisites for clinical investigations of medical devices; Annex X to the Directive 93/42/EEC provides a clearer definition of clinical evaluation.

We will be happy to support you with the clinical evaluation of your product. Just contact us and together we will find the solution that best fits you and your product.

In the scope of quality assurance, medical device manufacturers have to proof integrated and comprehensive fault management. In particular deviations that have been recorded but not tracked completely and corrected with adequate measures are in the focus of audits and inspections.

CAPA is a quality management concept and was adopted from the US FDA by the new EU GMP guideline. The focus of CAPA is on the systematic assessment of discrepancies (e. g. failure and/or deviation) and the attempt to prevent repetitive occurrence (corrective action) or to prevent occurrence a priori (preventive action).

Metecon supports you in the successful implementation of the CAPA concept so that your documentation fully meets the expectations of authorities and notified bodies. Just call us – we look forward to getting to know you!

A new medical device has to overcome the obstacles of regulatory approval before it may be launched on the market. To apply for this approval, the results of technical inspections, laboratory tests, simulations, etc. need to be submitted in writing. To standardize the format of these applications worldwide, the Global Harmonization Task Force (GHTF) developed the Summary Technical Documentation (STED).

A STED summarizes the development process of a medical device. It proves how the manufacturer assesses and rates the medical device’s quality, effectiveness, safety, and clinical benefit. Furthermore, it explains to what extent the product conforms to an accepted and/or published standard.

A STED should include the following six main chapters:

1. Device Description:
Description of the product, the intended use, the exterior and interior structure, classification according to the definitions of the Act on Medical Devices,

2. Labelling:
List of required labelling (pictograms according to DIN EN ISO 980) associated with the device itself, the instructions for use, and promotional material,

3. Design and Manufacturing Information:
Overview of the device’s individual manufacturing stages,

4. Essential Principles Checklist:
List of essential principles that offers evidence of the device’s conformity,

5. Risk Analysis and Control Summary:
Overview of the risks identified during the risk analysis process and how these risks have been controlled,

6. Product Verification and Validation:
Overview of the device’s verification and validation as well as of materials used for its manufacture.

Yes, we are ISO 13485 and ISO 9001 certified. The certificates are available for your reference and download in pdf format in our download center.