The impact of new European Medical Device regulations
The New Regulation (EU) 2017/745 for medical devices (MDRs), which went into effect on May 26, 2021, is a major update to the regulatory framework in the European Union (EU). As such, the entire industry is focusing on preparing for compliance.
The good news is that the new regulation varies from product to product; the primary additions are related to documentation, with additional product information and traceability requirements. But, even if new requirements do not impact the functionality or risk profile of the products, medical device manufacturers’ compliance requirements are significant.
Manufacturers trust Siemens as the manufacturing solutions leader in MD&D which is why Siemens has summarized the new MDR requirements in this article with the aim to give MD&D companies the critical facts about the regulations, and provide support to medical device manufacturers on what they should be doing to ensure compliance.
What are the EU medical device manufacturer obligations? How are EU manufacturers preparing for compliance? These are just a couple of the recurring questions that manufacturers in the MD&D industry are looking for and that Siemens is addressing with its solutions.
You can find out more in our latest article!
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