The Sterilization Road Map to Authorization in the EU
Sterile Medical Devices must follow the regulations and standards for CE marking that went into effect May 2021. Medical devices being sold in Europe require a CE mark, even if the product is imported from outside the Economic European Area (EEA). CE marking certifies that a medical device complies with regulatory requirements under European Regulation (MDR 2017/745 and IVDR 2017/746). Upon receipt of the certification / CE mark the product can be freely marked, sold, and marketed anywhere in the Economic European Area (EEA).
In this webinar, the strategic process of obtaining a CE mark, the defined product use and classification, as well as sterilization conformity assessment will be covered. Additionally, the interaction and experiences with contract sterilizers regarding MDR will be reviewed, including key validation information required for obtaining a CE mark for a sterile product.
Medical device manufacturers developing new products or improving the design, or packaging of new or existing products are invited to register for this free webinar to gain a greater understanding of the:
- The process to obtain a CE mark and certification under updated EU and ISO regulations.
- Ensure compliance with regulations and product/process safety.
- Understand the interactions with a contract sterilizer, for the validation process and submission requirements to obtain a CE mark for a sterile medical device.
About the Speakers
Regulatory Compliance Associates® (RCA) provides regulatory compliance consulting to the following industries for resolution of life science challenges:
- Life Sciences
- Biologic & Biotechnology
- Sterile compounding
- Medical device
- Lab Testing
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.