Silver Lining on the Horizon

Dr. Stefan Menzl, PhD "What inspires me everyday is how applied medical technology makes a positive change to patients lives. Qserve offers the unique combination of a global reach, high level of expertise and staff with field experience and former positions at manufacturers, Notified Bodies, US FDA or China CFDA."
Up until last week, the European Continent was under pressure as the regulatory changes [MDR/IVDR etc.] are going to affect the Supply Chain of Medical Devices and Diagnostics. The entire MedTech community is making efforts to mitigate this challenge. 

The EU is increasing the number of Notified Bodies and MedTech companies are increasing their efforts to bring their quality management system (QMS) and technical files in line with the requirements of  MDR and IVDR.

According to the German Association of Medical Technology BVMed, the tendencies of the MDR regulatory system are going in the right direction, but the certification capacities are still not sufficient. Therefore, the medical technology industry continues to call for the extension of the transition periods based on a risk-based approach or the abolition of the existing sell-off period.

At present, 36 Notified Bodies are designated under the MDR. This is six more than on 14 June 2022. Furthermore, 26 applications for designation as Notified Bodies are currently being processed; three of them are in an advanced stage. Based on the feedback received from Notified Bodies to the latest survey in October 2022, Notified Bodies have received 8,120 applications from manufacturers and have issued 1,990 certificates under the MDR. According to a rough estimation presented by Notified Bodies to the MDCG on 17 November 2022, the number of MDR certificates issued by May 2024 may reach around 7,000 if the current rate of certificate issuance continues with no changes to current conditions. This is in stark contrast to 22,793 valid certificates issued under Council Directives 90/385/EEC and 93/42/EEC that will expire by 26 May 2024 at the latest. Of those 22,793 certificates, 1,387 certificates will have expired by the end of 2022, 4,311 certificates will expire in 2023, and 17,095 certificates in the first five months of 2024. 

Regarding Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), the number of Notified Bodies designated remains low with only seven Notified Bodies designated so far; 10 applications for designation are in progress, two of them in an advanced stage.

The numbers show that although more certificates have been issued since April 2022, the capacities will still be far from sufficient for all certificates to prevent negative consequences for patient care and the market launch of innovations.

Based on this, two initiatives provide a certain level of hope for industry and patients.

On 28 November 2022, the Swiss Federal Assembly (parliament) voted in favor of accepting medical devices with US FDA marketing authorization in Switzerland, citing concerns about product availability and the situation of the lapsed Mutual Recognition Agreement with the EU.
Although the Swiss Federal Council again urged against accepting US FDA products, the National Council sided with industry, with 100 votes to accept and 79 votes to reject.

With this, both chambers within the Swiss Parliament have voted to adopt the initiative.

The specifics are currently still unknown. At the moment it is still unclear if e.g. all risk classes of devices will be accepted, if there will be a transition period or if additional assessment or review requirements will be placed on FDA versus CE Marked devices.

The implementation of regulation would be an enormous benefit to companies that have US FDA marketing authorization and might contribute to a secure supply of life-saving devices for the Swiss population. 

Almost in parallel information from the EU Commission was published on 6 December 2022. It does represent an update regarding the state of play on the implementation of the Medical Device Regulations.

Following the calls expressed at the June EPSCO Council, the MDCG endorsed a position paper (MDCG 2022-14) on 25 August 2022, laying out 19 non-legislative actions within the current regulatory framework with a view to enhancing notified body capacity, access to notified bodies and manufacturers’ preparedness in order to support a successful transition to the MDR and IVDR.

At its extraordinary meeting on 17 November 2022, the MDCG agreed on a uniform and coherent approach to the use of market surveillance provisions as a bridging action before the transitional period would be extended by an amendment of the MDR.

Despite their full support for the MDCG position paper 2022-14, several Member States, some Members of the European Parliament and stakeholders consider that those actions will not be sufficient and are calling for additional measures, namely an urgent, targeted legislative initiative to amend the MDR. At the MDCG meeting on 24-25 October 2022, at the meeting of the Council Working Party for pharmaceuticals and medical devices on 28 October 2022, and at the extraordinary MDCG meeting dedicated to the transition to the MDR on 17 November 2022, a large number of Member States’ representatives spoke in favour of an extension of the transitional provisions provided for in Article 120 MDR linked to certain conditions in order to give manufacturers and Notified Bodies more time to conduct the necessary conformity assessment procedures.

The Commission will present the likely elements of a legislative proposal for a targeted amendment of the MDR and IVDR during the EPSCO Health Council on 9 December 2022.

Those likely elements are based on the input received so far from national experts and stakeholders and could include

⮚an extension of the transitional period in Article 120(3) MDR with staggered deadlines depending on the risk class of the device. Those deadlines could be 2027 for class III and class IIb devices (i.e. devices with a higher risk) and 2028 for class IIa and class I devices (i.e. lower risk devices) that need the involvement of a notified body in the conformity assessment; 

⮚ if needed for legal and practical reasons (including for access to third country markets), the extension of the transitional period could be combined with an extension of the validity of certificates issued under Council Directives 90/385/EEC and 93/42/EEC by amending Article 120(2) MDR; 

⮚ conditions to be fulfilled in order to ensure that the extension applies only to devices that do not present any unacceptable risk to health and safety, have not undergone significant changes in design or intended purpose and for which the manufacturers have already undertaken the necessary steps to launch the certification process under the MDR, such as adaptation of their quality management system to the MDR and submission and/or acceptance of the manufacturer’s application for conformity assessment by a notified body before a certain deadline (e.g. 26 May 2024); 

⮚ the removal of the ‘sell off’ provision in Article 120(4) MDR and Article 110(4) IVDR.

It remains to be seen what the final decision will be, but there is definitely a silver lining on the horizon giving hope to industry and patients in Europe that existing and new medical devices remain available on the market.


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