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The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

Environmental sustainability: the EIPG perspective


Piero Iamartino Although the impact of medicines on the environment has been highlighted since the 70s of the last century with the emergence of the first reports of pollution in surface waters, it is only since the beginning of the Read more

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The current status of the transition to the MDR and IVDR regulations

December 8, 2023 , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

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.


MDCG, a position paper on the capacity of notified bodies

October 14, 2022 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

by Giuliana Miglierini

The lack of a suitable capacity of notified bodies (NBs) is one of the main issues still pending after the entry into force of the new Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. The Medical Devices Coordination Group (MDCG) discussed some suggestions on how to address the problem within a position paper published in August 2022.

Even if the document does not represent an official guideline, it describes some critical points to be considered by manufacturers and notified bodies in order to face the great challenge of the re-certification of medical devices and in vitro diagnostics according to the new rules. Should this not occur in time, many products may exit the market at the end of the transition period, potentially leading to a supply crisis greatly impacting on the health of patients and the normal functioning of healthcare institutions.

The MDCG position paper answers the request of EU Health ministers advanced during the EPSCO Council meeting on 14 June 2022 to figure out some immediate measures to face the problem. The final goal of the document is to improve the efficiency in the application of the current regulatory framework, with no reduction of requirements to be fulfilled by manufacturers. Waivers from applicable conformity assessments procedures should be considered only in relation to an interest of public health, patient’s safety, or health.

The position paper consists of nineteen points addressing the issue under its different perspectives, the first eleven of which refer to the increase of notified bodies’ capacity. The MDCG calls on all stakeholders to collaborate in order to smoothly implement the suggested actions, a process that will be monitored by the MDCG itself.

How to increase the capacity of NBs

Hybrid audits should be the elective tool notified bodies may use where appropriate to timely and efficiently run conformity assessment. Duplication of activities should be also avoided. To this instance, the suggestion is to “develop a framework for leveraging evidence, or components thereof, from previous assessments” run according to previous Directives. A pre-condition to activate this possibility is that the previous assessment has been judged “valid and properly substantiated also with regard to the MDR/IVDR requirements and the device” by a duly qualified notified body personnel.

A flexible approach may also apply to the combination of audits for legacy devices and actions needed to guarantee their ‘appropriate surveillance’. Combined audits may be used particularly for legacy devices whose application for MDR/IVDR certification is under review by a NB, thus moving the focus more towards the assessment of compliance with the new rules. To this instance, the MDCG also announced the intention to produce a specific guidance on ‘appropriate surveillance’ under Article 110(3) IVDR and to update MDCG 2022-4.

Already existing guidance may also be reviewed to reduce the administrative burden for NBs, and remove limitations related to the scope of documentation not required by MDR/IVDR.

A fundamental piece of the new European infrastructure for medical devices and IVDs is represented by the centralised Eudamed database, which should be timely fed by NBs with all relevant information using machine-to-machine procedures. Double registrations should be avoided as much as possible.

New notified bodies are essential in order to increase capacity. To this instance, the MDCG suggests supporting training, coaching and internship activities for their personnel. The rationalisation of internal administrative procedures is also deemed important.

Time for re-assessment of NBs is undergoing a review by the European Commission, which is expected to result in the publication of new Delegated Acts. The proposal is to move from the current first re-assessment at three years after notification (and then every 4th year) to up to five years after notification, on the basis of a flexible approach. There are currently ten re-assessments planned in 2022, twelve in 2023 and 11 in 2024. According to the MDCG, the new timeframe for re-assessment would allow national designating authorities to free resources to assess new NBs, while existing ones could process higher numbers of first MDR/ IVDR certifications.

Assessment, designation and notification of conformity assessment bodies (including the European Commission) are also called to reduce their timeframes and improve the efficiency of their processes, keeping unaltered the requirements to be met. The possibility to add specific codes to the designation of NBs shall be also explored by the MDCG. The Group is also committed to prioritise some ongoing actions which may impact on NB’s capacity (i.e. revision of section III.6. of MDCG 2019-6 revision 3).

MDCG’s guidance documents should be seen as an aid “to apply the legal requirements in a harmonised way, providing possible solutions endorsed by the MDCG”. Nevertheless, demonstration of the compliance to requirements should always benefit of a certain flexibility. A reasonable time should also be granted to integrate the new guidance in the relevant systems and/ or to apply them, suggests the MDCG.

Suggestions for the manufacturers

Under the perspective of manufacturers of MDs and IVDs, costs to access NBs may play an important role, especially for small-and-medium companies (SMEs). The MDCG position paper recalls NBs to the obligation to make their standard fees publicly available, possibly in a way that might be easily compared. Specific access schemes should be also in place to make available some capacity to SMEs and other first-time applicants for conformity assessment.

Manufacturers should also refer to notice MDCG 2022-11 to ensure timely compliance with MDR requirements. IVDs should not left behind, even if this category of products benefits of one more year for the transition to new rules compered to medical devices.

Structured dialogue is the suggested tool to improve the collaboration between manufacturers and notified bodies along the entire process of conformity assessment aimed at regulatory procedures, should this approach turn to be useful in order to improve the overall efficiency and predictability.

A timely communication to manufacturers by mean of webinars, workshops, targeted feedback and informative sessions is also deemed important in order to allow for a better preparedness, with a particular attention to SMEs and first-time applicants. The MDCG also suggest NBs to develop common guidelines for manufacturers to assist them in the application phase, containing explicative examples of typical non-conformities and details on he preparation and content of technical documentation. National authorities and industry associations are called as well to contribute to the dissemination of relevant information across their stakeholders.

Specific guidance should be issued by the MDCG to support a simpler conformity assessment of some aspects of legacy and orphan devices denoted by a demonstrable track record of safety. The development of a specific definition of “orphan devices” is also planned.

An improved dialogue between NBs and medicines authorities, and cases where expedited review would be possible is also supported in order to speed up consultations on medical devices incorporating an ancillary medicinal substance and companion diagnostics.