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Notizie recenti

Article 16(4) Certification Scheme >

We are pleased to inform you that we are expanding our Notified Body services to offer a new certification scheme for MDR and IVDR: Article 16(4) Certification.

Rollout of EU Reference Laboratories for IVDR Class D devices >

As part of BSI Regulatory Services, Medical Devices commitment in maintaining IVDs manufacturers up to date on the EU regulatory framework developments, we issue this communication in regard of the rollout of EU Reference Laboratories and oversight of Class D IVDs in Europe.

(EU) 2023/607 – 26 September 2024 deadline approaching >

On 20 March 2023, the Regulation (EU) 2023/607 amending the MDR and IVDR was published in the Official Journal of the European Union (OJEU) with immediate effect.

Client communication: EUDAMED gradual roll-out >

Medical Device Regulation (MDR), and In Vitro Diagnostic Regulation (IVDR) require manufacturers and Notified Bodies to submit certain information and documentation to the EU database EUDAMED (European Database on Medical Devices).

BSI is Accredited by the Singapore Accreditation Council (SAC) >

We are now accepting application for Singapore Accreditation Council (SAC) accredited ISO 13485 certification

IVDR Transition Timelines Extended >

On 9 July 2024, the Regulation (EU) 2024/1860 was published in the Official Journal of the European Union (OJEU) with immediate effect.

BSI first Notified Body to publish its capacity and lead times for MDR & IVDR applications and conformity assessments >

In a bold move BSI has published its Notified Body capacity and an overview of the lead times for MDR & IVDR applications and conformity assessments.

BSI establishes new regulatory team: Software as a Medical Device (SaMD) >

BSI has unveiled a strategic initiative aimed at enhancing its approach to Software as a Medical Device (SaMD) and SaMD with Artificial Intelligence (AI). This move underscores BSI's commitment to fostering innovation while maintaining the highest standards of quality and compliance in the healthcare industry.

(EU) 2023/607 – 26 May 2024 deadline approaching >

Manufacturers to put in place an MDR compliant QMS and formally apply to a Notified Body under MDR On 20 March 2023, the Regulation (EU) 2023/607 amending the MDR and IVDR was published in the Official Journal of the European Union (OJEU) with immediate effect

Impact of (EU) 2023/607 on legacy devices and update on BSI implementation >

On 20 March 2023, the Regulation (EU) 2023/607 amending the MDR and IVDR was published in the Official Journal of the European Union (OJEU) with immediate effect.

EU Commission proposal as regards transitional provisions for certain IVDs >

On 23 January 2024, the European Commission released a proposal regarding the transitional provisions for certain legacy in vitro diagnostic medical devices by providing manufacturers and notified bodies with additional time, under certain conditions, to complete applications and necessary conformity assessment procedures.

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