New MDCG Guidance documents released

On November 29th, 2023, the Medical Device Coordination Group (MDCG) released the first revision on the position paper on the notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements. (MDCG 2022-11 Revision 1). This position paper calls for the continued full commitment of all actors involved, including notified bodies and industry to avoid shortages of devices needed for the EU healthcare system.

MDCG 2020-03 Rev. 1 – Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD. (MDCG 2020-03 Revision 1).

The position paper recognizes that the designation process for notified bodies has improved, and individual notified bodies have increased their internal capacity to be able to handle more applications for conformity assessment.

However, data provided by notified bodies in June 2023 shows limited progress in terms of applications submitted and certificates issued:

Medical Devices

• Of the 24.000 certificates issued MDD/AIMDD, only around 13.000 MDR applications have been lodged
• 900 certificates have been issued, out of those 3.900 issued MDR certificates (around 1.000 are related to updates)
  
  

The situation is even more worrisome for IVDs. As a reminder, under IVDD only around 8% of IVDs required notified body involvement for conformity assessment. Under IVDR 80% needs a notified body involved for the conformity assessment.

• Of the 1500 certificates issued under IVDD, only around 1150 IVDR applications have been lodged
• 500 certificates have been issued under IVDR
  
  

The above numbers show that applications submitted by manufacturers, for both Regulations but especially for IVDR, remain low. It appears that manufacturers should continue to strengthen their efforts to transition their products and to initiate the certification process.

Manufacturers should keep in mind that the conformity assessment takes longer under the Regulations then under the Directives. For IVDs the average time between submission and approval is between 13 and 19 months, sometimes even up to 24 months.

Call to action for Manufacturers:

1. To ensure a smooth transition and make the best possible use of the additional time provided by the amended MDR and IVDR, submit your applications for conformity assessments in good time:
   1. Devices that upclassify to class D under IVDR should apply no later than the end of 2023, applications should be complete and of high quality.
   2. Class C, apply no later than 2026.
   3. Class B, apply no later than 2027.
2. To regularly provide data to the authorities and the European Commission on the situation regarding their devices, eg. by completing this survey.

Call to action for Notified bodies:

1. To streamline the certification process to make the certification process more efficient, transparent and predictable.
2. To assist manufacturers with regulatory guidance and technical information on how to apply for the conformity assessment procedure as this is key for a smoother and faster process and to avoid incomplete applications.
3. To regularly provide data on the situation regarding the certification of devices.
4. To increase transparency around their capacity and timelines for conformity assessment and specifically to make publicly available.
5. The MDCG also reminds notified bodies to organise structured dialogues with manufacturers, which is expected to be part of the normal pre-application and conformity assessment activities and therefore not to be a separated service to be charged for.