Euro Roundup: Transition to MDR underway for 63% of outgoing Directives certificates

The number of applications for certification under the Medical Device Regulation (MDR) almost doubled to 9,615 last year, according to a survey of notified bodies. Team-NB, the notified body trade group, said its members have received filings for 63% of the remaining certificates issued under the outgoing device directives.

Team-NB (The European Association Medical Devices - Notified Bodies), surveyed its 33 members to understand the state of the sector and gauge the progress of the transitions to MDR and the In Vitro Diagnostic Regulation (IVDR). One takeaway is that 2022 was the biggest year yet for submissions for certification under MDR. Team-NB called the trend “good news,” while cautioning about getting too encouraged by the evidence of an acceleration in the transition to the new regulations.

“Be aware that this positivity needs to be considered, as many applications are for smaller scopes than those on the Directives certificates. We are told that it is mainly because MDR Technical Documentations for all devices are not ready. Moreover, it is to be noticed that the new legislation will require more certificates issued to the MDR Regulation than were issued to the Directives. For example, a certificate will be issued for each class IIb implantable device,” according to a press release from Team-NB.

In addition, the trade group said that “the way manufacturers are structuring their families, taking Basic UDI-DI into consideration,” may further increase the number of certificates. The upshot is that the research is unable to pinpoint exactly how much work still needs to be done. Team-NB said the progress in 2022 was too slow to meet the original MDR transition dates, without offering an opinion on the likelihood of avoiding disruption under the revised timeline.

Evidence of ongoing problems with the completeness of submissions provides another cause for caution. Under the new framework, notified bodies are required to ensure they have received the complete technical documentation before starting their review. Most (81%) of surveyed notified bodies are already performing completeness checks and the rest said they will start as soon as they are designated against a regulation.

Among the notified bodies that are doing completeness checks, 80% said “the technical documentations submitted are missing half of the needed information and thus they request additional information to be able to start the assessment.” The figure is up 4% compared to last year. Team-NB had expected a decrease because of “the learning curve” and its release of consensus Technical Documentation Best Practice Guidance documents.

The 2022 data also reveals a steep fall in the number of valid certificates, despite Team-NB collecting data from three more notified bodies last year than in 2021. Team-NB suggested that the 10% decrease in the number of valid certificates may reflect the 1,301 certificates that were withdrawn between May 2021 and the end of last year.

Another potential contributor to the expiration of certificates is manufacturers that “either have decided not to continue the putting on the market of the devices or have not found a solution to prolong the validity of the certificates.” Because Team-NB collected the data prior to establishment of the revised transitional provisions, it is possible that companies with already expired certificates may now have more time to place their products on the market, Team-NB said.

Team-NB Report, Press Release

UK MHRA publishes regulatory guidance on Software and Artificial Intelligence as a Medical Device

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has created guidance that covers the outputs of its Innovative Devices – Software Group. MHRA created the group to ensure the safety of, and access to, Software and Artificial Intelligence as a Medical Device (SaMD/AIaMD).

As MHRA explains in the guidance, the software group works across the agency, for example by helping with pre- and postmarket enquiries from manufacturers, conducting technical file reviews and ensuring medical device regulation is fit for purpose. Other areas of focus include industry engagement and the review of the technical and clinical aspects of clinical investigations.

The rest of the guidance rounds up materials related to SaMD and AIaMD, such as advice on when a software application is considered to be a medical device, creating an intended use statement and reporting adverse incidents. MHRA has also included a link to the guiding principles on good machine learning practice for medical device development that it created with its counterparts in North America.

Other sections of the guidance address upcoming changes, including MHRA’s plans for a SaMD and AIaMD “Change Programme.” The change roadmap, which MHRA first disclosed in 2021, is intended to drive the reform of qualification and classification, pre- and post-market requirements and other aspects of the SaMD regulations.

MHRA is also using the program to consider the challenges and opportunities posed by AIaMD. The goal is to ensure the devices are backed by appropriate evidence and to address issues related to the retraining and interpretability of AI models.

MHRA Guidance

EDQM seeks feedback on draft general chapter about the quality of human phage therapies

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is gathering public opinions on a draft general chapter that describes considerations related to the quality of phage therapy.

Phage therapy entails using naturally occurring bacterial viruses (bacteriophages) to treat bacterial infections. Interest in the modality waned in the West in the 1940s but persisted in parts of the Soviet Union, notably Georgia. The emergence of drug-resistant bacteria and failure of the antibiotic R&D pipeline to produce new treatments has led to a resurgence in interest in phage therapy.

“Addressing the quality of phage therapy has therefore been identified as a significant ongoing project for the European Pharmacopoeia Commission (EPC) in the field of biologicals and fulfilling the increasing expectations of users and being prepared for the future developments in this fast-moving field are amongst the EPC’s priorities for 2023-2025,” EDQM wrote.

To support those objectives, EPC’s newly created Bacteriophages Working Party has drafted a general chapter on phage therapy. The draft chapter is open for comment until the end of June.

EDQM Notice

MedTech Europe calls for solutions to MDR and IVDR implementation and governance challenges

MedTech Europe has called for the European Union to “focus on solving the remaining MDR and IVDR implementation and governance challenges” now that it has changed the transitional timeline.

The trade group issued its statement in response to the passage of the amendment to MDR and IVDR and the subsequent publication of a European Commission Q&A on practical aspects of implementing the revised regulatory plan. MedTech Europe welcomed the publication of the Q&A but also called for further changes.

In addition to the call for the resolution of the remaining MDR and IVDR challenges, the trade group made the case for officials to focus on “creating clear regulatory pathways for strengthening the role of the European Union as an attractive region for research, innovation and development.”

Press Release

Other news:

MHRA has lifted the suspension on NuVasive’s PRECICE Titanium subset of devices after assessing technical and biological safety data. MHRA Notice

Euro Roundup: Transition to MDR underway for 63% of outgoing Directives certificates

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