Package Insert 42
Interesting facts and figures for customers and partners of mt-g.
October 2017
In the spotlight
Medical Device Regulation
For some time now, the medical engineering sector has been looking to Brussels with bated breath: The new regulations relating to
  • Medical devices (Medical Device Regulation [MDR])
  • In-vitro diagnostics (In-Vitro Diagnostic Regulation [IVDR])
were published in the Official Journal of the European Union in May 2017 and will be valid from May 2020.

The new regulations are designed to make medical devices and in-vitro diagnostics inherently safer. The motivation for this push was provided not least by the breast implant scandal, which raised the question of safety standards for medical devices. In order to achieve the production of safe products, the European legislative bodies prescribed some changes to the existing medical device directives, which must be implemented by medical device manufacturers within a transitional period of three years, or five years for in-vitro diagnostics manufacturers.

For example, one of the changes introduced is the Unique Device Identifiers (UDI for short). A unique code is assigned to each medical device, thereby ensuring improved traceability. This will make individual products or batches easier to identify, which can simplify field safety corrective actions, for example. The use of UDIs is also intended to combat product counterfeiting.

The classification of medical devices is also set to change. Going forwards, medical software, in particular, will probably only rarely be classified in Class I – for which the requirements are less complex; instead, it will be classified as Class IIa at the least. This means considerable additional work for developers/manufacturers, as the documentation requirements are significantly more extensive in higher classes. The same applies to Class IIb implants, which will probably be moved up to Class III, thereby increasing the already extensive regulatory requirements still further.

The fact that these changes will not be welcomed by all manufacturers and experts should be obvious, and these sentiments may also already have been expressed within your company. Opinion is divided on one question in particular: Is it really the legal requirements that are the problem or is it rather the lack of control on the market that actually needs improvement?

When increased requirements are introduced, that is ostensibly all well and good, but should it not be the checks carried out by the relevant bodies and authorities that prevent misuse? And does it not just generate costs for companies that are ultimately not offset by any substantial increase in safety when it comes to marketing the product?

Despite all the uncertainty, it is likely that the increased documentation requirements will result in an increased demand for translation. Within the context of clinical evaluation, the MDR generally requires more evidence and documents than was the case for the MDD. For example, within the scope of the technical documentation to be taken into consideration, brochures, catalogues and packaging texts are now also required in addition to technical specifications.

We must therefore be ready for the responses and the measures implemented by manufacturers. If you already require translation of your documentation in the meantime, please do not hesitate to contact us! We will be only too pleased to help you.

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