by Giuliana Miglierini
As the term to apply for the certification of medical devices and in vitro diagnostics according to regulation 607/2023 approaches (24 May 2024), new data have been published by the European Commission on the current status of the procedures. The critical goal for all the stakeholders involved in reaching compliance with the new rules in time is to avoid the risk of seeing many products excluded from the market.
The last release of the Notified Bodies Survey on certifications and applications run under the DG SANTE’ Framework contract reports data from notified bodies (NBs) designated under MDR/ IVDR until 30 June 2023.
The Medical Devices Coordination Group (MDCG) also updated its position paper “Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements”.
The Notified Bodies Survey on certifications and applications
The Notified Bodies Survey was launched by the European Commission in December 2022 and will close in December 2025. All the 39 notified bodies included in its last release responded to the survey. The majority of them (29) are designated only under the MDR, 9 both under the MDR and IVDR and just 1 only under the IVDR.
Data for medical devices show that there are currently 22.793 total valid certificates referred to Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD, on active implantable devices). The great majority of them (17.045) will expire during 2024. As for 30 June 2023, there were 13.177 applications filed to comply to the new MDR (+22% compared to October 2022), and 3.899 issued certificates (+32%).
The great part of both applications and certificates refer to devices that need to meet requirements listed in Annex IX (classes I&III and II). Many of the applications and certificates refer to the Quality Management System (QMS, 9.071 and 2.682 respectively), while product ap-plications and certificates were respectively 4.106 and 1.217. A small part of the applications (388) refers to devices incorporating a medicinal substance, thus requiring the activation of the consultation procedure with pharma regulatory authorities (57 issued certificates). The survey also indicates it takes a mean of one to three months to reach signature of the written agreement for applications filed for changes of already MDR issued certificates.
The main reasons for the refusal of the certification include the fact the application is outside the scope of the NB’s designation (47%) or is incomplete (27%). To this instance, the percentage of submissions with a completeness rate > 50% is still low (21% in June 2023, vs 31% in October 2022). The survey also indicates it takes a longer time to obtain MDR QMS + product certificates (13-18 months for 40% of NBs), compared to just the QMS certificate (6-12 months for 45% of NBs).
As for products with no intended medical purpose that fall under the scope of the MDR, the collected data show an increase of the requests to sign a written agreement for a conformity assessment procedure of an Annex XVI product. This trend is expected to continue further in 2024, as well as the estimated transit of MDD certificates for Annex XVI products to the MDR without maintaining the medical purpose for the covered devices.
As for certification applications in accordance with Annex VII section 4.3 of MDR (Application review and contract), the survey reports a total of 15.530 applications and 9.422 signed written agreements (+28% vs the results of the survey closed on 31 March 2023).
The situation for vitro diagnostics
The survey run in October 2022 showed a total of 1.551 valid IVDD certificates. In this case too, the great part of certificates will expire in 2024 (482) and 2025 (866).
The trend of applications and certificates is similar to that of medical devices, with a total of 1.155 applications received as for June 2023 (+22% compared to March 2023) and 500 granted certificates (+51%). Again, the great majority refers to products following Annex IX requirements.
As for class D devices (i.e. IVDs aimed to detect or exposed to transmissible agents which are life-threatening or have a high risk of propagation), the survey reports a total of 231 applications received by June 2023, and 62 certificates. Incomplete applications are again the main reason for refusal of certification. Times required to reach certification are also similar to those seen for medical devices.
MDCG’s amendments to the Notice to NBs and manufacturers
Revision 1 of the MDCG position paper 2022-11 is focused on the new section which calls notified bodies to streamline the certification process, and on the revision of the one referred to manufacturers to submit applications without delay.
The MDCG’s document adds further details to the above seen data from the survey. According to the Coordination Group, the actions taken to facilitate the transition and improve NBs’ capacity (MDCG 2022-14, e.g. use of hybrid audits, deferral of re-assessment of notified bodies, etc.) are showing good results.
Despite the increased number of notified bodies designated under the MDR and the IVDR (40 and 12, respectively), the MDCG highlights that data from the survey indicates limited progress for both the applications and certifications. “This shows that manufacturers tend to transfer at different times devices to be included in the same certificate. Whilst this approach is understandable, it might create issues in planning and in the capacity of notified bodies”, wrote the Coordination Group, also underlining the more worrisome situation for IVDs.
On this basis, the MDCG calls the manufacturers “to make the best possible use of the additional time provided by the amendments of the MDR and IVDR by submitting applications for conformity assessment in good time”.
The position paper also comments on the need to file complete and high-quality applications, so to avoid undue delays in the certification process, possibly before the end of 2023 as strongly recommended by notified bodies.
Manufacturers are also expected to regularly provide data on their devices, to increase transparency, improve the exchange of information on specific medical devices and support institutions and Member States in preparing for changes to product ranges.
As for notified bodies, the MDCG asks them to make the certification process more efficient, transparent, and predictable. Streamlined procedures should be the main objective, together with the need to operate in accordance with consistent, fair, and reasonable terms and conditions.
The position paper highlights the importance for notified bodies to provide regulatory guidance and technical information to manufacturers on how to apply for the conformity assessment procedure, so to avoid any issue and delay with the application and certification process.
The MDCG also recalls the importance to support small and medium size companies, and to organise structured dialogues with manufacturers as a part of the normal pre-application and conformity assessment activities. Notified bodies are also expected to regularly provide data on the progress made as for certification, capacity, and timelines for conformity assessment. To this instance, the tool suggested by the position paper would see the activation of a publicly available, common website.
EDQM introduces a consultation phase in the management of CEP documents
by Giuliana Miglierini
The new process implemented by the European Directorate for the Quality of Medicines and HealthCare (EDQM) for the elaboration of documents related to the Certification of Suitability (CEP) procedure includes a newly inserted consultation phase. This new step, which may be public or targeted to specific groups of stakeholders, aims to increase the transparency of the elaboration process and offers stakeholders the possibility to forward comments to the draft documents in order to optimise them.
Transparency and efficiency are also the main goals inspiring the overall new elaboration process, which covers the entire pathway of CEP documents, from development, through consultation, up to final adoption, publication and implementation.
A dedicated page on the EDQMs’s website will host the documents open to consultation, together with the respective instructions for the stakeholders wishing to submit comments. Announcements on new documents available for consultation will be made on EDQM Certification webpages. The CEP Steering Committee will be responsible for the elaboration process for CEP documents, in compliance with the EDQM document CEP Terms of Reference and Rules of Procedure (PA/PH/CEP (01) 1).
The elaboration process will cover both public documents (the main part), as well as those the CEP Steering Committee would indicate as restricted for use by the bodies involved in the CEP procedure. The new process does not cover the Resolution on the Certification procedure, which falls under another specific process established by the Council of Europe.
A guidance to understand the new process
The management of CEP guidelines and operational documents for the CEP procedure has been described in a specific guidance issued in November 2022 by the EDQM’s Certification of Substances Department.
The guidance covers a broad range of documents participating from different perspectives to the CEP procedure. The elaboration of the different types of documents may slightly differ from one another, with possible exemptions from some steps, for example in the case of minor revisions (which in any case always have to be full justified and documented). All CEP documents will be drafted in English; the guidance provides indication of the format to be used to establish the unique reference code for governance documents and technical guidelines (PA/PH/CEP (XX) YY), as well as for the revision number (ZR) where needed.
The EDQM specifies that the implementation date of the newly approved CEP documents will be such to allow interested parties to have enough time to comply with the new or revised requirements.
Governance documents define procedural aspects for the practical implementation of the CEP procedure. The initial draft will be prepared by the EDQM and reviewed and agreed upon by the CEP Steering Committee before entering the consultation phase. Comments collected will serve as the basis to consolidate the final version of the document. A second round of consultation may be needed in case of critical comments preventing finalisation. The adoption of the final document falls under the responsibility of the CEP Steering Committee, which may also indicate the need to improve and re-submit the draft before adoption. Once the final version of the document is available, its publication on the EDQM’s website and implementation will close the process.
Technical guidelines inform about the requirements applicants should fulfil for the submission or evaluation of CEP applications. Their drafting may be initiated also by members of the relevant Technical Advisory Board (TAB), in addition to the EDQM. The TAB is also called to review and agree upon the draft document before the assessment and approval by the CEP Steering Committee and the following consultation phase can take place. The same applies to the consolidation of comments and finalisation of the document, that has to be approved by the relevant TAB. In this case too, a second round of consultation is possible should criticalities arise during the first one, followed by adoption by the CEP Steering Committee (and a possible second round of updating and approval by the TAB, if needed), and publication and implementation.
The management of specific aspects of the procedure can be supported by the issuing of administrative or operational documents. These documents fall under the responsibility of the EDQM, that may consult the CEP Steering Committee of other parties where necessary.
The consultation phase
A specific chapter of the EDQM’s guidance describes the newly inserted consultation phase, those details (type of process and duration) will be decided on a case-by-case basis by the CEP Steering Committee.
In the case of a public consultation, the draft document will be made available at the dedicated page of the EDQM website. The draft may also be sent to identified relevant stakeholder organisations, to ensure a better awareness of the ongoing process.
Targeted consultations aim to obtain feedback from selected stakeholders on specific areas of intervention. In such instances, the forwarding of the draft document will be restricted only to identified interested parties, including regulators and relevant industrial associations or other organisations.
According to the type of document and/or the topic under consultation, the consultation phase may vary in duration. To this instance, the guidance indicates a possible range between 3 weeks and 3 months, with the effective duration to be communicated as a part of the call for consultation. A template will also be available to submit comments, which should be always justified and contain concrete proposals for action to tackle the issue under consideration. All comments and justifications received will be transmitted to the groups in charge of approving and adopting the documents.
At the end of the elaboration process, the final approved versions of CEP documents will be published on the EDQM’s website.