The MDCG recognises that significant and urgent challenges remain in ensuring sufficient capacity of notified bodies and readiness of manufacturers in order to allow medical devices and in vitro diagnostic medical devices to be certified in accordance with the MDR and the IVDR within the transition periods provided for in the Regulations. The data gathered to date indicate that there are multiple causes which require a mix of solutions.

At the EPSCO Council meeting on 14 June 2022, Health Ministers expressed their concerns that these challenges, if left unaddressed, may lead to disruption of supply of devices needed for health systems and patients and may jeopardise the access of innovative medical devices to the European market. Health Ministers called on the MDCG to propose solutions to address immediate challenges as a matter of urgency. The proposed actions outlined in this document are intended to improve the efficiency of application of the regulatory requirements, rather than reducing, avoiding or removing requirements, in particular in relation to safety.

For this purpose, the MDCG lists the following actions to enhance notified body capacity, access to notified bodies and manufacturers’ preparedness in order to facilitate transition to the MDR and IVDR and to avoid shortage of medical devices. The MDCG will implement and/or support the implementation of the actions listed in a timely manner, assess the progress and the impact of those actions, and assess whether further actions are needed. To this end, the MDCG counts also on the full commitment of all actors involved, including notified bodies and industry, to implement the actions and provide the data necessary for the monitoring of the market by the MDCG.

Even though the above mentioned challenges are currently more pressing in the area of the MDR, most of the actions listed in this document also apply in the area of the IVDR.

Supporting the transition to the MDR and IVDR is a continuous process, which may require adding actions to those listed in this position paper.

• Increase notified bodies’ capacities

1. The MDCG advises notified bodies to make use of hybrid audits where they consider that this would contribute to conducting the conformity assessment in a timely and efficient manner in compliance with the Regulations.

2. In order to avoid unnecessary duplication of work, the MDCG encourages notified bodies to develop a framework for leveraging evidence, or components thereof, from previous assessments conducted with regard to requirements under the Directives for the purpose of conformity assessment procedures under the Regulations, provided that duly qualified notified body personnel deem the previous assessments by the same or another notified body valid and properly substantiated also with regard to the MDR/IVDR requirements and the device under assessment. [actor: NBCG-Med, NBO]

3. With regard to ‘appropriate surveillance’ of legacy devices, the MDCG calls on notified bodies to make full use of the flexibility described already in MDCG 2022-4 on ‘appropriate surveillance under Article 120(3) MDR. This includes combining audits under the Directives and the Regulations for ‘legacy devices’ whose application for MDR/IVDR certification is being reviewed by the notified body; focussing on assessment of compliance with MDR/IVDR requirements instead of surveillance of compliance with Directives’ requirements; and also abandoning sampling plans for technical documentation assessments under Directive 93/42/EEC. The MDCG commits to develop guidance on ‘appropriate surveillance’ under Article 110(3) IVDR and to update MDCG 2022-4. [actors: MDCG, NBO]

4. The MDCG will review its guidance with a view to eliminate administrative workload of notified bodies or undue limitations regarding the scope of documentation not required by MDR/IVDR (1). [actors: NBCG-Med to identify workload not required by MDR/IVDR; relevant MDCG sub-groups]

5. The MDCG considers that in the framework of the development of Eudamed it should be ensured as soon as possible that notified bodies can upload relevant information machine-to-machine. Moreover, generally the MDCG acknowledges that double registrations should be avoided to the extent possible (2). [actors: MDCG, Eudamed WG, European Commission]

6. MDCG calls upon all parties involved to foster capacity-building of existing and potential new notified bodies by means of training, coaching and internship activities for their personnel (3). In addition, notified bodies should rationalise and streamline internal administrative procedures, and ensure that proper conformity assessments are carried out in a timely and efficient manner in accordance with the Regulations. [actors: notified bodies]

7. The MDCG welcomes the preparation of Commission Delegated Acts to modify the frequency of complete re-assessments of notified bodies, based on Article 44(11) MDR and Article 40(11) IVDR. Currently, a complete reassessment with a joint assessment team needs to be carried out 3 years after notification and then every 4th year. According to current planning, 10 re-assessments are due to be launched in 2022, 12 re-assessments in 2023 and 11 re-assessments in 2024. The timing for the first complete re-assessment after notification could be deferred to up to 5 years after notification, while providing certain flexibility as regards the exact timing and addressing re-assessments that have already been launched. It would allow national designating authorities to focus on the assessment of new notified bodies and alleviate notified bodies from being subject to a complete re-assessment in a moment when they need their resources to process high amount of first MDR/IVDR certifications. In order to foster mutual trust in the system, the designating authorities will provide details of the outcome of their monitoring and on-site assessment activities regarding notified bodies to the MDCG and the Commission in their annual reports in accordance with Article 44(12) MDR / Article 40(12) IVDR. [actors: European Commission, MDCG, NBO]

8. At the same time, the MDCG calls upon all parties involved in the assessment, designation and notification of conformity assessment bodies to continue to make all efforts to speed up this process, while preserving the level of requirements to be met by notified bodies under the Regulations. Especially in respect of conformity assessment bodies that are in an advanced stage of assessment, the European Commission, designating authorities and conformity assessment bodies should reduce, where possible, the timing to complete activities in order to allow timely designation of additional notified bodies under MDR and IVDR. [actors: European Commission, Designating Authorities, Joint Assessment Teams, Conformity Assessment Bodies]

9. The MDCG will explore means to add codes to the designation of notified bodies (4) in a timely manner in accordance with the Regulations. For this purpose, the MDCG will consider the depth of the assessment and possibilities of an expedited process. The MDCG notes that the lifting of conditions or limitations of designations as well as changes within codes should not be considered as extension of the scope of designation. [actors: European Commission, MDCG, NBO]

10. The MDCG commits to prioritise actions that are ongoing in the MDCG or its sub-groups, which aim at contributing to enhancing notified body capacity, such as the revision of section III.6. of MDCG 2019-6 revision 3 regarding the meaning of ‘personnel employed by the notified body’ referred to in Article 36(1) MDR / Article 32(1) IVDR. [actors: MDCG and its subgroups]

11. As regards the status of MDCG guidance documents, MDCG reminds that their main objective is to assist economic operators, notified bodies and competent authorities to apply the legal requirements in a harmonised way, providing possible solutions endorsed by the MDCG. Having regard to the status of guidance documents (5), economic operators and notified bodies should be allowed flexibility as to how to demonstrate compliance with legal requirements. Moreover, reasonable time needs to be given to integrate new guidance in the relevant systems and/or to apply them. That means that new guidance should not be applied to ongoing processes or applications already launched by a conformity assessment body for designation and/or a manufacturer for conformity assessment, unless application of such guidance yields increased efficiency of the process.

• Access to notified bodies

12. The MDCG reminds notified bodies of their obligation to make their standard fees publicly available (Article 50 MDR / Article 46 IVDR), taking into account the interests of SMEs in relation to fees (section 1.2.8 of Annex VII MDR / IVDR). The MDCG also encourages notified bodies that fees published are easy to compare.

13. Moreover, the MDCG calls on notified bodies to develop schemes in order to allocate capacity for SME manufacturers and first-time applicants and ensure access of SMEs and first-time applicants to notified bodies for conformity assessment. [actors: NBCG-Med, MDCG]

• Increase preparedness of manufacturers

14. The MDCG reminds manufacturers of its notice MDCG 2022-11 (6) calling on manufacturers to ensure timely compliance with MDR requirements. The MDCG also calls on manufacturers to ensure timely compliance with IVDR requirements as soon as possible, making use of available notified body capacities, and not wait until the end of the transition periods. The MDCG is committed to supporting the transition to the Regulations and avoid shortage of devices.

15. The MDCG encourages notified bodies and manufacturers to organise structured dialogues before and during the conformity assessment process aimed at regulatory procedures where this is useful to enhance the efficiency and predictability of the conformity assessment process, while respecting the independence and impartiality of the notified body. Such dialogues should not be considered consultancy service (7). [actors: MDCG, NBO]

16. In order to increase preparedness of manufacturers, especially SMEs and first-time applicants, to adapt to the high-level standards set up by the Regulations, the MDCG calls on all parties involved to continue and, where possible, to step up communication with manufacturers by means of webinars, workshops, targeted feedback and informative sessions (8). E.g. notified bodies are invited to work on common guidelines for manufacturers to assist them in the application phase, including information about typical non-conformities and preparation and content of technical documentation. National authorities are invited to continue to promote awareness and engagement with relevant stakeholders at national level, and to exchange between them best practices about information campaigns (9). Also industry associations are invited to promote and ensure awareness of economic operators of the legal requirements. [actors: CAMD, NCAs, NBCG-Med; EU business associations]

• Other actions facilitating transition to MDR/IVDR and/or avoiding shortage of devices

The MDCG considers that, in particular for safe and effective legacy devices, including orphan devices, the complexity of conformity assessments should be reduced and more pragmatism ensured with regard to the demonstration of compliance with the applicable requirements. For this purpose, the MDCG commits to undertake the following additional actions with highest priority:

17. Provision of additional guidance to notified bodies and manufacturers to assist with the practical application of Article 61 MDR (clinical evaluation) (10), and possibly Article 56 IVDR (performance evaluation and clinical evidence), and to make appropriate use of MDCG guidance on clinical evidence for legacy devices (11) and clinical evaluation – equivalence (12). In combination with the possibility for notified bodies to issue certificates under conditions (13) or combined with the requirement to carry out PMCF / PMPF studies (14), this action will increase the necessary flexibility to apply the reinforced clinical evidence requirements to devices that have a demonstrable track record of safety. [actors: MDCG, NBO, CIE, NBCG-Med]

18. The MDCG acknowledges the specific situation of ‘orphan devices’ and will pursue work with a view to providing a definition for ‘orphan devices’ and suggesting specific guidance or other means of assistance for those products to be able to meet the legal requirements. Sustainable solutions are also needed in the mid- and long-term for orphan devices. [actors: MDCG TF on orphan devices]

19. The MDCG urges medicines authorities to accept and efficiently process consultations by notified bodies regarding medical devices incorporating an ancillary medicinal substance (15) and regarding companion diagnostics. Medicines authorities should ensure that in case of devices already certified following a medicines authority’s consultation under MDD/AIMDD (16), an expedited review is carried out following the recommendation in MDCG 2020-12 (17). Medicines authorities are invited to support notified bodies in identifying availability of medicines authorities for determined devices. The MDCG calls upon the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) to take action ensuring that the consultation of medicines authorities is carried out in a cost-efficient and timely manner, in particular as regards devices that had undergone the consultation under MDD/AIMDD. [actors: EMA, HMA]

Finally, the MDCG recalls that derogations from applicable conformity assessments procedures may be granted by competent authorities only if the use of the device concerned is in the interest of public health, patient safety or patient health. Mechanisms provided in Chapter VII of the Regulations, such as market surveillance measures, may only be applicable for devices for which manufacturers can demonstrate that they have undertaken all reasonable efforts to transition to the Regulations (18). MDCG will explore the application of such measures and, where relevant, work towards a coordinated, transparent and coherent approach.