Product Certifications:
SIGNIFICANT CHANGES AHEAD FOR MEDICAL DEVICE/ IN VITRO DIAGNOSTICS DEVICE MANUFACTURERS
On March 15, 2023, a new law was passed that gives medical device manufacturers more time to get their devices certified. This is to help prevent shortages of medical devices and ensure high level of public health protection, including patient safety without lowering current quality or safety requirements. Regulation(EU) 2023/607 – Transition regulations related to EU MDR 2017/745 refers to transitioning process to EU MDR.
To simplify the interpretation of the Regulation(EU) 2023/607, following are the pre-requisites for existing Certificate Validity Extension :
- The Medical Device shall not undergo significant change in Design and/or intended use since the issuance of Certificate as per MDD 93/42 EC.
- Continued surveillance audit of the certified Medical Devices with successful audit results
- Have a compliant QMS as per EU MDR 2017/745
- Enter into certification Contract with EU NB preferably by May 26, 2024 and deadline for entering into certification contact being September 26, 2024.
The EU also removed its 12-month “sell-off” provision so non-transitioning medical devices that comply with the EU MDD may now be supplied in the EU, after May 2025, until the stock is depleted. The “sell-off” provision was also removed from the In Vitro Diagnostic Regulation (EU IVDR) that started on 26 May 2022, with staggered transition between 26 May 2025 and 26 May 2028. Transition dates are unchanged for IVD medical devices.
The CE mark audit and certification services are provided in co-operation with EU based and recognised Notified Bodies.
Our Competent personnel are approved by the EU Notified bodies to carry the effective and efficient assessment on Product certification and Quality Management system audits.
Training
- Lead Auditor/ Internal Auditor /General Awareness Training on ISO 9001, ISO 13485, ICMED 9000, ICMED 13485.
- General Awareness Training MDR 2017/745, IVDR 2017/746, MDSAP, Risk Management, Clinical Evaluation, Post-Market surveillance and relevant key subjects.
Disclaimer: All the training programs are conducted at neutral venues. The training materials provided and taught during the training program are available in public domain. Customised training programs which may be misinterpreted as Consultancy are not provided.