RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2022 > 4 > Euro Roundup: MDCG adds guidance on legacy devices, Eudamed to IVDR to-do list

Euro Roundup: MDCG adds guidance on legacy devices, Eudamed to IVDR to-do list

Posted 07 April 2022 | By Nick Paul Taylor 

Euro Roundup: MDCG adds guidance on legacy devices, Eudamed to IVDR to-do list

The Medical Device Coordination Group (MDCG) has updated its joint implementation and preparedness plan for the In Vitro Diagnostic Regulation (IVDR), adding sections on legacy devices and Eudamed in recognition of the need for guidance on what will happen in May 2022.
 
With the EU staggering the implementation of IVDR, more tests will become legacy devices – products  that are placed on the market under the old directive – than  was originally planned. IVDR makes a reference to the regulation of legacy devices, but MDCG thinks the “wording of this paragraph is rather general,” creating a need for it to clarify the specific requirements that apply to legacy devices starting in May 2022.
 
To that end, MDCG has added new guidance to its list of priority actions. The objective is to cover the application of IVDR requirements to legacy devices, as MDCG has already done for the Medical Device Regulation (MDR). MDCG listed the second quarter of 2022 as the timeline for the guidance, which is still at the consultation stage.
 
A new section on Eudamed has been added as well. Since  the Eudamed database will not be fully functional in May 2022, use of the system will not be mandatory or enforceable when IVDR takes effect. MDCG concluded it would be beneficial to “have guidance on harmonized administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.”
 
MDCG envisages the guidance enabling member states and other stakeholders to “meet their obligations under the IVDR effectively while minimizing any potential additional burden on the parties concerned.” The coordination group is mainly focused on “cases where the exchange of information would be difficult, or even not possible, to achieve in absence of guidance.” The guidance has a second-quarter timeline and is at the consultation stage.
 
The updated IVDR also features new priority actions on guidance for notified bodies and performance evaluation and expert panels. The two texts are in preparation with second and third quarter timelines.
 
MDCG Update
 
EFPIA finds persistence of 500-plus day average time to reimbursement in Europe
 
The average time to reimbursement for innovative medicines in the EU and European Economic Area is still over 500 days, according to an EFPIA analysis. The trade group found a gulf between the fastest and slowest turnarounds, with Germany taking 133 days and Romania taking 899 days.
 
EFPIA (the European Federation of Pharmaceutical Industries and Associations) has run this type of analysis since 2004. The latest publication shows that the average time for medicines availability across 39 European countries was 511 days last year, up slightly from 2020. Those averages mask considerable variation between product classes. For orphan medicines, the average wait was 636 days, compared to 407 days for combination therapies.
 
There also were geographic differences. The average wait in Germany, Denmark and Switzerland was under 200 days, while it was over 800 days in Poland, Albania and Romania. The wait was shorter in Western Europe, but there were exceptions. The delay in Belgium and Ireland was above average.
 
EFPIA Notice, 2021 Report
 
EMA finds no clear evidence to support fourth dose of Moderna or Pfizer vaccines
 
It is too early to consider giving a fourth dose of the mRNA COVID-19 vaccines from Pfizer/BioNTech and Moderna to the general population, according to findings from the European Medicines Agency (EMA) COVID-19 task force. However, the agency does back a fourth dose in people aged 80 years and up.
 
Working with the European Centre for Disease Prevention and Control, the task force concluded there is no clear evidence that protection against severe disease is waning substantially in adults with normal immune systems aged 60 to 79 years. As such, the authorities ruled there is insufficient data to support the immediate use of a fourth dose. The situation is the same in those aged under 60 years.
 
The data, most of which comes from Israel, will inform potential national vaccination campaigns in the fall. “As re-vaccination campaigns could start in the autumn, authorities will consider the best timing for additional doses, possibly taking advantage of updated vaccines,” EMA wrote.
 
EMA Notice
 
Denmark puts better use of data and new technology at heart of new regulatory plan
 
The Danish Medicines Agency (DKMA) has put better use of data and new technology at the heart of its strategy for 2022 to 2026. DKMA thinks the new initiatives can improve its professional assessments and processes.
 
With Lars Bo Nielsen taking over as director general last year, DKMA has set out its areas of focus for the first years of his tenure. DKMA wants to “turn threats from technological development in society into strengths,” adding that it will “exploit artificial intelligence, robotic technology and digital transformation” to optimize and develop its processes and review procedures.
 
There remains some uncertainty about what that will mean in practice. “Whereas the possibilities are many, we regrettably do not have endless resources. We must therefore choose wisely and cost-consciously when we select the development targets for this area,” DKMA wrote.
 
DKMA Notice
 
EMA creates forum with academics to inform prioritization of actions to fight cancer
 
EMA has set up the Cancer Medicines Forum to support the prioritization of anticancer actions in the Regulatory Science Strategy to 2025 and the Academia Collaboration Matrix Action Plan.
 
The forum, which EMA set up with the European Organisation for Research and Treatment of Cancer, brings regulators and representatives from academic organizations together to optimize cancer care. EMA founded the forum in the belief there is an opportunity to improve the optimal use of treatments when they come to market.
 
With that goal in mind, the forum met recently to discuss challenges around dose optimization and other ways of tailoring treatments to patients. The forum will meet every quarter during its one-year pilot phase. After that, EMA and its collaborators will reevaluate the forum’s composition and procedures.  
 
EMA Notice
 
Dutch MEB changes policy on implementing additional risk minimization measures
 
The Dutch Medicines Evaluation Board (MEB) has revised its policy on the national implementation of additional risk minimization measures for human medicines.
 
MEB’s update emphasizes that marketing authorization holders must make risk minimization materials available on their own websites. The material cannot just be published by MEB. The agency also clarified that the risk minimization material for generics and biosimilars should be identical to that of the reference product when possible.
 
Other changes include the recommendation to use comprehensible language in materials aimed at patients, and a call for the use of QR codes in materials that refer to online risk minimization documents.
 
MEB Notice
 
Other news:
 
The European Commission has begun developing strategic reserves for chemical, biological and radio-nuclear emergencies. As a first step, the EU has used its €540.5 million ($590 million) rescEU program to procure potassium iodide tablets that protect against certain effects of radiation. The EU has shipped almost 3 million iodide tablets to Ukraine. Press Release

 

© 2022 Regulatory Affairs Professionals Society.