What software validation services can be offered ahead of new EU MDR deadline
Following the postponement of EU MDR by a year, Dave Easton, director of Zener Engineering Services, outlines what ZES can offer ahead of the new deadline in 2021.
Recently the EU Parliament voted to postpone the enforcement of the new Medical Device Regulation by one year until 26 May 2021. The proposal is expected to be approved by the EU Member States and published in the Official EU Journal before the delay enters into force. Delay approval by the EU Member States is expected by 26 May 2020.
The transition periods for the new MDR and IVDR regulations originally began back in May 2017 and were expected to last for three and five years respectively. Therefore, the MDR and IVDR would have fully applied in EU Member States from 26 May 2020 and 2022. However due to the Coronavirus outbreak, a delay has been voted for by the EU Parliament which requires full approval by Member States. If full approval is provided by Member States, the new implementation dates for the new regulations are now expected to be 26 May 2021 and 2022 respectively. The postponement is expected to only apply to the MDR and not have any impact on the IVDR go-live date, which remains 26 May 2022.
ZES are experts in medical device software validation, in line with MDR, IVDR, ISO 13485, GAMP 5 guidance and IEC 62304, and its software validation services include:
- Medical device validation plans and summary reports
- Validation gap analysis
- Position statements
- Risk assessments
- Software validation
- Inventory management
- Validation strategy implementation adopting a risk-based approach
- Electronic record and electronic signature assessment and remediation
- CSV training delivered by industry experts
- Full life cycle documentation generation and protocol execution
ZES can also provide, and has experience of, the following:
- Regulatory advice and support for registration and conformity of medical devices in EMEA regions and emerging markets
- ISO 13485, MDR 2017/745, IVDR 2017/746, compliance advice and implementation
- Liaise with regulatory authorities and prepare meeting packages with relevant agencies
- Plan and organise registration submissions and registrations
- Create from scratch technical files
- Full new product development lifecycle experience from conception to commercialisation
- Achieve CE markings
- 510(k) clearances: advice, documentation generation and validation
- Manufacturing facility design, project management, installation and validation
- Ensure device construction complies with ISO 60601
- Ensure software complies with IEC 62304
- Software validation
- Project management and review
- Implementation of a suitable management strategy for medical device cybersecurity
- Information Security to ISO 27001