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SGS rounds up the latest Q3 updates on the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR).
SGS rounds up the latest Q3 updates on the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR).
SGS contributes to the fight against COVID-19. To support hospitals and patients during this difficult period. As a Notified Body, SGS has focused its resources on supporting manufacturers of COVID -19 related devices – ventilators, CT scanners – to help them get their products to market quickly (in collaboration with the European Competent Authority) and provide safe solutions to doctors, nurses and patients.
In these challenging times we have devised remote audit processes and guidance to ensure that your certifications and ability to deliver are unaffected. We have tried to keep these as simple as possible and all our auditors and assessors have been trained on them. Our partnership is an essential element of our common business continuity.
As a consequence of the COVID-19 pandemic, on April 23, 2020, the EU Commission released Regulation (EU) 2020/561 MDR which postponed the date of application of the Medical Device Regulation (MDR) for one year. Therefore, the transition period for implementation of the MDR, and thus the transition period for Medical Device Directive (MDD) certification, has been extended until May 2021.
Although this gives manufacturers more time, the expectations of the new MDR mean that strategies to ensure full compliance should be underway already, and you should not be tempted to delay. Consider this extra time an opportunity to reinforce your preparation and integrate all published Medical Device Coordination Group (MDCG) guidance. More extensive Post-market Surveillance (PMS), post-market clinical follow-up (PMCF) and related clinical requirements of MDR pose considerable challenges for medical device companies. Transition planning is a key activity that you should be engaging in with SGS, as your Notified Body.
As previously reported, SGS has a cut-off date for any new MDD activities of November 30, 2020 as, according to MDR transitional provision (article 120) and implementing act (EU) 2020/558 approved on April 23, 2020, we will not be allowed to issue any CE MDD certificates after May 25, 2021. This cut-off date provides SGS with enough time to complete any MDD work started before then, allowing us to ensure those MDD certificates can be issued before the end of the MDD transition period in May 2021.
What does the cut-off date fixed on the 30th November 2020 mean?
For more information please contact your local SGS office.
Following this postponement, we have updated our available transition plan. Download the most up to date version >
At present there has been no proposal from the EU Commission to postpone the In Vitro Diagnostic (IVD) Regulation’s date of application, which still stands as May 26, 2022.
After the successful migration of our client’s MDD certificates to SGS Belgium (Notified Body 1639) in March 2020, our primary focus has been the MDR designation for SGS Belgium. Although we have reached the final stages, the COVID-19 pandemic has had a serious impact on the work of member state Competent Authorities and the EU Commission itself, which understandably has been their major priority over the last few months to meet the unprecedented public health crisis. We are hopeful that the designation process will now be back on track and our expectations from Belgian Competent Authority (FAHMP) are for final designation in 2021. Our continued strategy is to rapidly follow this through with attaining In Vitro Diagnostic Regulation (IVDR) designation afterwards, using the experience gained with MDR designation.
The European Commission has launched a new medical devices website, hosted on the portal of the Directorate-General for Health and Food Safety (DG SANTE).
The website contains information and advice for all stakeholders in the medical devices and in vitro medical devices business and gives useful information on their roles and responsibilities within the context of the new MDR and IVDR. It also contains new information related to the impact of the COVID-19 pandemic.
The various working groups within the EU commission continue to work on multiple subjects needed to implement the MDR and IVDR.
Since our last update newsletter in April 2020, the Medical Device Coordination Group (MDCG) has published many new, or updated, documents that can be consulted at Guidance - MDCG endorsed documents.
The most important topics are:
The European Commission has also published documents specific to COVID-19:
Do you have a question on UDI? Please consult the recently published FAQ document from European commission.
Our Medical Devices Regulation Implementation Training Course is now available remotely.
Please consult our webpage to find out the next date of your MDR training.
For more information, please contact:
Virginie Siloret
Global Product Manager - Medical Devices Regulation
t: +41 22 739 98 58
Sharon Williams
Global Product Manager - IVDR
t: +44 (0) 19 345 22 917