DO MEDICAL DEVICE MANUFACTURERS NEED TO COMPLY WITH THE NEW IVDR?
DO MEDICAL DEVICE MANUFACTURERS NEED TO COMPLY WITH THE NEW IVDR?
The Answer is YES.
The European Commission (EC) has updated and relaxed regulatory conditions for COVID-19 critical devices in order to ensure continuous supply in the EU market. Furthermore, the competent authorities have defined country-specific approval criteria for these critical devices. The European Union (EU) has delayed the implementation of the Medical Device Regulation (MDR) by a year, until May 26, 2021. The MDCG has issued guidance documents on the regulatory specifications for ventilators and related accessories, medical face masks, compliance assessment procedures for 3D printing and 3D printed items, and other safety equipment in response to COVID-19.
The Medical Device Coordination Group (MDCG) has published a number of documents related to the introduction of the EU MDR and IVDR. IVDR has provided guidance on interpreting the classification rules mentioned for IVD. Articles 120 (3) and (4) of the MDR, Article 54(2)b, and the provision of Article 18 under the EU MDR for Implant cards have all received relevant guidance documents. Also updated a position paper on UDI assignment.
The publication of position papers on the use of the EUDAMED actor registration module and the Single Registration Number in Member States, as well as guidelines on the use of EMDN – nomenclature in EUDAMED, demonstrated progress in the EUDAMED implementation. Registration for EUDAMED’s Actor module is now available. The database will be used to register suppliers, European approved members, and importers. The remaining EUDAMED modules are scheduled to be published in 2021.
To assist device manufacturers, a large number of documents were published for Notified Bodies and Clinical and Performance Evaluation of MDV and IVDs, including templates for Clinical evaluation assessment report, PMCF plan template, and PMCF evaluation report. Under the MDR and IVDR, guidance was issued on safety reporting in clinical investigations, proper clinical evidence of legacy devices, equivalence-based clinical assessment, clinical evidence, and performance evaluation of Medical Device software.
The United Kingdom has left the European Union, with a transition period set to end on December 31, 2020. After the transition phase, the UK MHRA will be in charge of overseeing medical device regulations, and the Agency has issued guidance on the product. More recommendations for medical device manufacturers are expected to be issued in the near future. In addition, the MHRA has held webinars to explain the new regulations in depth, allowing for a smooth transition.
CATEGORY: Medical Devices, Regulatory Affairs
Keywords: Medical Devices, European Commission (EC), MDCG, Medical Device Co-ordination Group, EUDAMED, Post Market Clinical Follow up PMCF, Medical Device Vigilance MDV, IVDR, Medical Device software, medical device regulations. Clinical and Performance Evaluation of MDV
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