Recognition of CE Certificates for Medical Devices in 2023: What You Need to Know?

The American Chamber of Commerce in Ukraine, jointly with the member company UNI-CERT LLC, is glad to invite you to the upcoming Knowledge Webinar “Recognition of CE Certificates for Medical Devices in 2023: What You Need to Know?” scheduled for Tuesday, October 17, 11:00 AM.

Don’t miss an exceptional opportunity to learn from speakers on the main principles of assessing the conformity of medical devices through the recognition of EU certificates.

During the webinar, we will discuss:

  • Changes to the requirements for documents regarding the introduction into circulation and/or operation of medical devices during martial law
  • Consequences of postponing the entry into force of Regulation (EU) 2017/745 (MDR)
  • Legal basis of the recognition procedure and necessary conditions
  • List of required documents
  • Step-by-step conformity assessment by recognition of the EU certificate
  • Validity of the certificate issued by recognition and other restrictions
  • Performing surveillance audits for certificates issued by recognition
  • Extending the validity period of MDD certificates

Speakers of the event:

Roman Mykhalko, Director UNI-CERT

Anna Telpiakova, First Deputy Director UNI-CERT

The event will be held in Ukrainian. Simultaneous translation will not be provided.

The event will be held under Chatham House rules and is open for employees of Chamber member companies only.

The event will be held in online format. The link for joining will be sent only to registered participants. Registration is required to participate. Deadline for register is Monday, October 16, COB.

Share this:

Other news

24.01.2022

Cosmetic product safety: production regulation

Quality management // № 1-2 (49-50), January 2022 Guaranteeing the safety of products for consumers is a very important component of the image of cosmetics manufacturers. The leading motivation for the transition to work on GMP will be the standardization of production processes and the implementation of measures that make it possible to produce high-quality, […]

Read more
13.06.2024

A contract on recognition of the results of the assessment of conformity with UDEM Uluslararası Belgelendirme Denetim Eğitim Merkezi San. ve Tic. A.Ş. (2292)

We are pleased to inform you that the notified body UDEM Uluslararası Belgelendirme Denetim Eğitim Merkezi San. ve Tic. A.Ş. (EU notified body 2292) has signed an arrangement for the recognition of conformity assessment results with the UNI-CERT LLC. Due to this collaboration, our clients can significantly reduce their time and financial expenses for certification […]

Read more
19.08.2024

Formation of a technical file for medical devices

The program of the event is available only on Ukrainian

Read more