The regulation of the medical device industry throughout Europe has gone essentially unchanged since the 1990s, so a reform was overdue and necessary in order to improve the standards, protocols, and processes in the design and manufacture of medical devices in Europe. If you sell medical devices in Europe you will need to comply with the EU MDR.
European Medical Device Regulation (EU MDR)
One recent significant reform was the adoption of the Proposal for a Regulation of the European Parliament and the Council on European medical devices (EU MDR) and in-vitro diagnostics (EU IVDR) in September 2021.
This proposal gave the medical device regulators a lot more control, power, and oversight of the Notified Bodies (independent third parties that perform conformity assessments for medium-risk and high-risk devices) and the whole medical device industry throughout Europe.
This regulation demanded the mandatory adoption of high standards in quality and safety not only in the medical devices that were manufactured in Europe, but also any devices being supplied to Europe.
In their April 2017 updated Medical Device Regulation (MDR), the European Parliament and Council released even stricter regulatory stipulations on how the EU will approve medical devices.
In May 2020, these new regulations will replace the current EU Medical Device Directive (MDD); these directives must be adhered to if medical device designers and manufacturers want approval to introduce their medical devices into the EU market.
The new EU MDR regulation encompasses these guidelines:
- All medical devices marketed in Europe must undergo a rigorous assessment of how safe they are and if they perform to the standards that they claim
- A transparency of information is demanded in order to identify the benefits to patients of the medical devices, as well as the overall risk/benefit ratio
- Succinct rules put in place to make standardization and support simpler and to make trading between EU member states less complex
- Support innovation and identify the specific needs of the many smaller manufacturers of medical devices
- Give more responsibilities to (while still scrutinizing) the independent third parties that perform conformity assessments on the devices
Compliance to the EU MDR will require medical device manufacturers to take on an enterprise-wide approach; every facet of the design, development, manufacture, marketing, distribution, and sale of the devices will be affected. Hence the need for translating medical devices software, user manuals, instructions for use, labels and packaging.
Because the regulations bring with them more scrutiny and accountability on the overall medical device industry, every level of the process – from clinical trials, test qualifications, performance evaluations, audits, software regulations, and cybersecurity are involved.
Since the EU MDR guidelines are mandatory, medical device manufacturers must also ensure every level of the device development and market process is translated into each language for each European state where they plan to promote and sell the device.
While each step of adhering to the EU MDR guidelines is equally important, being able to precisely explain and present all the requirements, information, benefits, and risks of the medical device is surely the most important.
It won’t matter if you’ve met all the requirements demanded of the EU MDR if you’ve not translated all those details at all! Don't waste time and contact us today to get a free quote for medical translation.