[May 22 Free QMS Seminar] EU and UK Medical Device/IVD Regulations: Reading from 2026 Latest Trends
Berry Inc. will host a free online seminar on May 22, 2026, featuring experts from BSI Group Japan. The session will cover the latest regulatory updates in the EU and UK, including EU MDR/IVDR, the EU AI Act, and UKCA marking, providing strategic tips for dealing with notified bodies.
📋 Article Processing Timeline
- 📰 Published: April 28, 2026 at 22:00
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BSI Group Japan, the largest notified body in the EU, provides a thorough explanation of trends in this period of regulatory transition.
Berry Inc. (Headquarters: Taito-ku, Tokyo; CEO: Yuji Nakano) will hold a free online seminar titled 'EU and UK Medical Device/IVD Regulations: Reading from 2026 Latest Trends - Updates on EU AI Act / EU MDR / IVDR and the UKCA Marking System' on Friday, May 22, 2026, from 14:00 to 15:30. We will welcome Mr. Junya Onae and Ms. Narumi Oishi from BSI Group Japan K.K., the Japanese subsidiary of BSI (British Standards Institution), which is the largest notified body in the EU and a leading approved body for the UKCA system. They will provide clear explanations of strategic response points during this regulatory transition period from the unique perspective of a certification body.
[Recommended for:]
- Companies exporting or considering exporting medical devices to the EU/UK markets.
- QMS managers and Quality Assurance departments proceeding with EU MDR/IVDR transition.
- Those who want to understand the impact of the EU AI Act on their products.
- Those seeking the latest information on the UKCA marking system.
- Those considering or struggling with changing their certification body.
- Those facing challenges in organizing multiple certification schemes such as ISO 13485 / MDSAP / PMDA.
- Those considering the introduction or improvement of eQMS.
[Background and Objectives of the Seminar]
Medical device regulations in Europe and the UK are at a major turning point, with the transition periods for EU MDR/IVDR reaching their climax and the enforcement of the 'EU AI Act,' the world's first AI legislation, beginning. For Japanese medical device manufacturers, it is essential to accurately grasp these regulatory changes and respond strategically to maintain and expand access to the EU and UK markets. However, in the field, many voices are heard saying, 'I can't decide where to start' or 'I'm struggling with how to deal with notified bodies' due to the difficulty of organizing information across multiple concurrent certification schemes like ISO 13485, MDSAP, PMDA, EU MDR/IVDR, and UKCA.
In this seminar, Mr. Junya Onae and Ms. Narumi Oishi from BSI Group Japan K.K. will take the stage. They will provide practical explanations of the latest 2026 regulatory updates and points for maximizing the use of certification bodies.
[Outline]
Date and Time: Friday, May 22, 2026, 14:00–15:30
Format: Online (Zoom planned)
Target Audience: QMS managers, QA departments, manufacturing managers, technical supervisors, management, etc.
Organizer: Berry Inc.
Participation Fee: Free (Pre-registration required)
[Seminar Content]
Part 1: 'EU and UK Medical Device/IVD Regulations: Reading from 2026 Latest Trends'
Speakers: Mr. Junya Onae and Ms. Narumi Oishi, BSI Group Japan K.K.
They will explain the latest 2026 update information on EU MDR/IVDR, EU AI Act, and the UKCA marking system, along with tips for dealing with notified bodies from BSI's unique perspective. They will provide specific points that Japanese manufacturers should keep in mind, such as prioritizing among parallel certification schemes and practical considerations during transition and audit responses.
Part 2: 'Introduction to QMSmart Solutions'
Speaker: Yuji Nakano, CEO, Berry Inc.
An overview and case studies of the cloud-based eQMS 'QMSmart' will be introduced. It will cover how to centralize QMS operations such as document management, quality event management (CAPA), and training, and how to improve onsite efficiency with AI-driven regulatory compliance checks and root cause analysis functions.
Part 3: 'Q&A Session'
Questions will be accepted during the webinar. The end time may be extended depending on the questions.
[Speaker Profiles]
Mr. Junya Onae (BSI Group Japan K.K.)
Joined BSI in September 2020, pursuing 'predictable' delivery excellence in EU MDR/IVDR, UKCA, MDSAP, ISO 13485, and PMDA certification. Before joining BSI, he spent approximately 18 years at a German certification body, serving as the head of testing, auditing, and certification for medical devices in the Asia-Pacific region and Japan.
Ms. Narumi Oishi (BSI Group Japan K.K.)
Joined BSI Group Japan's medical device certification division as a sales representative in July 2021 from another industry.
Berry Inc. (Headquarters: Taito-ku, Tokyo; CEO: Yuji Nakano) will hold a free online seminar titled 'EU and UK Medical Device/IVD Regulations: Reading from 2026 Latest Trends - Updates on EU AI Act / EU MDR / IVDR and the UKCA Marking System' on Friday, May 22, 2026, from 14:00 to 15:30. We will welcome Mr. Junya Onae and Ms. Narumi Oishi from BSI Group Japan K.K., the Japanese subsidiary of BSI (British Standards Institution), which is the largest notified body in the EU and a leading approved body for the UKCA system. They will provide clear explanations of strategic response points during this regulatory transition period from the unique perspective of a certification body.
[Recommended for:]
- Companies exporting or considering exporting medical devices to the EU/UK markets.
- QMS managers and Quality Assurance departments proceeding with EU MDR/IVDR transition.
- Those who want to understand the impact of the EU AI Act on their products.
- Those seeking the latest information on the UKCA marking system.
- Those considering or struggling with changing their certification body.
- Those facing challenges in organizing multiple certification schemes such as ISO 13485 / MDSAP / PMDA.
- Those considering the introduction or improvement of eQMS.
[Background and Objectives of the Seminar]
Medical device regulations in Europe and the UK are at a major turning point, with the transition periods for EU MDR/IVDR reaching their climax and the enforcement of the 'EU AI Act,' the world's first AI legislation, beginning. For Japanese medical device manufacturers, it is essential to accurately grasp these regulatory changes and respond strategically to maintain and expand access to the EU and UK markets. However, in the field, many voices are heard saying, 'I can't decide where to start' or 'I'm struggling with how to deal with notified bodies' due to the difficulty of organizing information across multiple concurrent certification schemes like ISO 13485, MDSAP, PMDA, EU MDR/IVDR, and UKCA.
In this seminar, Mr. Junya Onae and Ms. Narumi Oishi from BSI Group Japan K.K. will take the stage. They will provide practical explanations of the latest 2026 regulatory updates and points for maximizing the use of certification bodies.
[Outline]
Date and Time: Friday, May 22, 2026, 14:00–15:30
Format: Online (Zoom planned)
Target Audience: QMS managers, QA departments, manufacturing managers, technical supervisors, management, etc.
Organizer: Berry Inc.
Participation Fee: Free (Pre-registration required)
[Seminar Content]
Part 1: 'EU and UK Medical Device/IVD Regulations: Reading from 2026 Latest Trends'
Speakers: Mr. Junya Onae and Ms. Narumi Oishi, BSI Group Japan K.K.
They will explain the latest 2026 update information on EU MDR/IVDR, EU AI Act, and the UKCA marking system, along with tips for dealing with notified bodies from BSI's unique perspective. They will provide specific points that Japanese manufacturers should keep in mind, such as prioritizing among parallel certification schemes and practical considerations during transition and audit responses.
Part 2: 'Introduction to QMSmart Solutions'
Speaker: Yuji Nakano, CEO, Berry Inc.
An overview and case studies of the cloud-based eQMS 'QMSmart' will be introduced. It will cover how to centralize QMS operations such as document management, quality event management (CAPA), and training, and how to improve onsite efficiency with AI-driven regulatory compliance checks and root cause analysis functions.
Part 3: 'Q&A Session'
Questions will be accepted during the webinar. The end time may be extended depending on the questions.
[Speaker Profiles]
Mr. Junya Onae (BSI Group Japan K.K.)
Joined BSI in September 2020, pursuing 'predictable' delivery excellence in EU MDR/IVDR, UKCA, MDSAP, ISO 13485, and PMDA certification. Before joining BSI, he spent approximately 18 years at a German certification body, serving as the head of testing, auditing, and certification for medical devices in the Asia-Pacific region and Japan.
Ms. Narumi Oishi (BSI Group Japan K.K.)
Joined BSI Group Japan's medical device certification division as a sales representative in July 2021 from another industry.