The deadline to comply under the MDR is May 2021 or after the expiration of CE Certificate issued under MDD 93/42/EEC (only valid for legacy devices)!
The deadline to comply under the MDR is May 2021 or after the expiration of CE Certificate issued under MDD 93/42/EEC (only valid for legacy devices)!
On the 24th of April 2020, Regulation 2021/561 was adopted and published, delaying the MDR by 1 year to May 26th 2021.
1-year delay will provide you with additional 6 months to finalize your compliance with the MDR, which is a complex and lengthy process!
On the 24th of April 2020, Regulation 2021/561 was adopted and published, delaying the MDR by 1 year to May 26th 2021.
1-year delay will provide you with additional 6 months to finalize your compliance with the MDR, which is a complex and lengthy process!
The MDR introduces a complete set of new requirements which require on average 18 months of preparatory work to achieve compliance – with only 6 months to the Date of Application (DoA), manufacturers must ensure they have taken all necessary actions:
The MDR introduces a complete set of new requirements which require on average 18 months of preparatory work to achieve compliance – with only 6 months to the Date of Application (DoA), manufacturers must ensure they have taken all necessary actions:
Scope has been expanded to include aesthetic devices
Classification system remains relatively unchanged with the addition of some new rules
Notified Bodies must become designated under the Medical Device Regulation
Authorized Representatives must meet upgraded requirements and have a designated Person Responsible for Regulatory Compliance (PRRC)
Introduction of Unique Device Identification (UDI) requirement
MDD I manufacturers will be required to create and continually update Clinical Evaluation Report (CER)
Scope has been expanded to include aesthetic devices
Classification system remains relatively unchanged with the addition of some new rules
Notified Bodies must become designated under the Medical Device Regulation
Authorized Representatives must meet upgraded requirements and have a designated Person Responsible for Regulatory Compliance (PRRC)
Introduction of Unique Device Identification (UDI) requirement
MDD I manufacturers will be required to create and continually update Clinical Evaluation Report (CER)
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All Right Reserved 2021 © Obelis Group
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Key Facts of the Medical Device Regulation:
Key Facts of the Medical Device Regulation:
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We ensure your continuous MDR & IVDR compliance!
We ensure your continuous MDR & IVDR compliance!
UNDERSTANDING
THE MEDICAL DEVICE REGULATION
UNDERSTANDING
THE MEDICAL DEVICE REGULATION
Contract liability insurance.
Contract liability insurance.
Presenting MDlaw.eu, the most extensive & up-to-date database on European MDR & IVDR!
Presenting MDlaw.eu, the most extensive & up-to-date database on European MDR & IVDR!
Review your Quality Management and Risk Management Systems in light of MDR Article 10 and ISO 13485:2016 (manufacturers of Class I devices are not exempted from this requirement!).
Review your Quality Management and Risk Management Systems in light of MDR Article 10 and ISO 13485:2016 (manufacturers of Class I devices are not exempted from this requirement!).
Re-asses the portfolio of your devices in view of classification changes and availability of sufficient clinical evidence.
Re-asses the portfolio of your devices in view of classification changes and availability of sufficient clinical evidence.
Review your technical documentation for your devices to align them with Annex II and III of the MDR.
Review your technical documentation for your devices to align them with Annex II and III of the MDR.
Review your clinical evaluation report (CER) in light of MDR Article 61 and Annex XIV.
Review your clinical evaluation report (CER) in light of MDR Article 61 and Annex XIV.
Implement a UDI system and assign basic UDI-DI to your devices, by 26 May 2021.
Implement a UDI system and assign basic UDI-DI to your devices, by 26 May 2021.
Check notification status of your Notified Body under the MDR.
Check notification status of your Notified Body under the MDR.
Ensure you have a professional Authorised Representative (if based out of EU).
Ensure you have a professional Authorised Representative (if based out of EU).
As soon as EUDAMED becomes public, register yourself and obtain a SRN!
As soon as EUDAMED becomes public, register yourself and obtain a SRN!
Plan the recruitment of a Person Responsible for Regulatory Compliance.
Plan the recruitment of a Person Responsible for Regulatory Compliance.
Envisage changes to the labelling, IFUs, promotional materials of your devices.
Envisage changes to the labelling, IFUs, promotional materials of your devices.
Comply with post-market surveillance requirements specified in MDR Articles 83-92.
Comply with post-market surveillance requirements specified in MDR Articles 83-92.
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