Celegence (www.celegence.com/services/me...) provides the medical device industry with consulting services that are tailored to the evolving needs of manufacturers.
Our suite of services including EU MDR related support allows you to focus on your core responsibilities. With our guidance, bringing your devices to the market and keeping them there will be easier for your regulatory and quality teams.
Due to the ever-expanding prevalence and complexity of Drug Device Combination (DDC) products, the EU MDR has put these products under greater focus. Manufacturers of DDCs will now be required to receive Notified Body opinions to ensure the safety and performance of the device element of the combination product. Outlined in Annex 1 of the MDR, the General Safety and Performance Requirements (GSPRs) are required to be met for combination products prior to placing them on the market.
During our webinar titled “Combination Products: Seeking a Notified Body Opinion According to MDR Article 117,” Joseph spoke specifically about combination product types, requirements, the importance of notified body opinions, and the scope of MDR article 117.
Why should you watch this webinar?
1. To comprehend the impact of Article 117 of the MDR on Drug Device Combination (DDC) products
2. To understand the current status/requirements for combination products as per MDR
3. For an explanation of the new requirements for DDC manufacturers according to the MDR 2017/745
4. To gain knowledge on Notified Body Opinions - Requirements & Processes
For more information on how we can support manufacturers of combination products to ensure that their essential documentation and clinical evidence complies under the new MDR, you can reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services - www.celegence.com/services/me...