MDR and IVDR Updates – Q3 2020

MDR and IVDR NewsSeptember 28, 2020

SGS rounds up the latest Q3 updates on the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR).

COVID-19 Pandemic News

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.

Date of Application for MDR Update

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?

No new initial onsite audits will be done after November 30, 2020, but we will continue to support you to close out existing CAR and TCAR already issued from audits prior to the cut-off, to provide you with a CE certificate before May 24, 2021
No scope extension under MDD after November 30, 2020. No onsite audit or technical file review for CE scope extension will be done after this date, but we will continue to support you to close out existing CAR and TCAR already issued from Extension to Scope reviews prior to the cut-off, to provide you with a CE certificate before May 24, 2021

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.

SGS Belgium (NB1639) Status

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.

EU Commission Launches New Medical Devices Website

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.

Visit the website >

European MDR and IVDR Corner

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:

UDI & EUDAMED
European Medical Device Nomenclature,
Updated documents associated to postponing of MDR application
Clinical investigation and evaluation (MDCG 2020-1, 2020-5, 2020-6, 2020-7, 2020-8, 2020-10 & 2020-13)
New version of Manufacturer Incident Report (MIR)
Common specifications for the reprocessing of single-use medical devices

The European Commission has also published documents specific to COVID-19:

Conformity assessment procedures for protective equipment
How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context
Guidance on regulatory requirements for medical face masks
Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19

Do you have a question on UDI? Please consult the recently published FAQ document from European commission.

Standards Update

General Standards

ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 10993-18:2020 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
ISO 10993-19:2020 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO/TR 20416:2020 Medical devices — Post-market surveillance for manufacturers
ISO/TR 24971:2020 Medical devices — Guidance on the application of ISO 14971

IVD Standards

ISO 17511:2020 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
ISO 21474-1:2020 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
ISO 21151:2020 In vitro diagnostic medical devices — Requirements for international harmonization protocols establishing metrological traceability of values assigned to calibrators and human samples

Product Specific Standards

ISO 18340:2020 Endoscopes. Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves
EN ISO 8624:2020 Ophthalmic optics. Spectacle frames. Measuring system and vocabulary
ISO 16672:2020 Ophthalmic implants – Ocular endotamponades
ISO 7207-2:2011+A2:2020 Implants for surgery. Components for partial and total knee joint prostheses. Articulating surfaces made of metal, ceramic and plastics materials
ISO 12891-2:2020 Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved surgical implants