Qualtech recently organized for a webinar, in partnership with ISS AG, on the European Market Access and Post Market Clinical Follow-up. This is the first part of a series of webinars Qualtech has been organizing on the newly implemented Medical Device Regulation MDR (EU) 2017/745 (MDR) and the dynamic European medical device landscape.
In this webinar, ISS AG’s founding members Dr. Ulrich Hofer and Mr. Hansjörg Riedwyl spoke about the important transitions from the MDD, AIMDD, IVDD to MDR and IVDR. Along with that, they also introduced points to take note of while placing a medical device in Switzerland, post-MDR & IVDR’s implementation. It is to be noted that since 26 May 2021, with the full application of the MDR and later the IVDR, and in the absence of an institutional agreement reached, Switzerland is officially considered a “Third Country” for Europe. In this article, let’s take a look at the important points discussed.
MDR 2017 brings along with it 10 most significant changes from the MDD, listed as below:
One important timeline to take note of is that, certificates issued by notified bodies in accordance with MDD and AIMDD prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate (or at the latest on 27 May 2024), except for certificates issued in accordance with Annex 4 to AIMDD or Annex IV to MDD, which shall become void at the latest on 27 May 2022.
It is to be noted that the MDR’s Article 120 -Transitional provisions allow medical devices certified under the MDD or AIMDD to be continued to be placed in the market, only if continues to comply with either of those Directives and provided there are no significant changes in the design and intended purpose. However, the requirements of MDR 2017 relating to post-market surveillance, market surveillance, vigilance, registration of economic operators, and of devices shall apply in place of the corresponding requirements in those Directives.
Class I medical devices certified under the MDD would be regulated by the MDR 2017, should they continue to be in the market post 26 May 2021 and they possess a valid Declaration of Conformity, according to Annex VII of the MDD, drawn before 26 May 2021. Such medical devices need to be wary of significant changes in their design and intended purpose, especially software as medical devices, during this period.
Manufacturers should also always remember to rearrange their technical documentation according to Annex II and III of the MDR, as their medical device is gearing towards being MDR-certified. There are significant changes introduced when it comes to labeling and instruction for use of medical devices under the MDR; it becomes manufacturers’ obligation to duly fulfill these requirements before placing their MDR-certified medical devices in the market post 26 May 2021.
Some substantial changes for the label include the introduction of UDI identification, the indication that the device is a medical device, and if the device intended for single-use, an indication of that fact. Substantial changes for the instructions for use include where applicable, a specification of the clinical benefits to be expected, links to the summary of safety and clinical performance (SSCP) (applicable for implantable and class III devices), more information about warnings, precautions, contraindications, limitations, information to be supplied to the patient with an implanted device (implant card), details of any preparatory treatment or handling of the device before it is ready for use (e.g. the levels of disinfection required), more information for processable devices (class IR), a notice to the user and/or patient that any serious incident should be reported to the manufacturer and the Competent Authority (CA) and many more.
As required by the MDR, all medical devices, regardless of risk class, should be given their own post-market surveillance (PMS) plan, and records are expected to be collected throughout their active lifetime. The PMS data shall be used to update, whenever necessary, the device’s risk management, design, and manufacturing information, IFU, label, clinical evaluation, SSCP, and when required, contribute to trend reporting. Higher risk class medical devices additionally require a PMCF and PSUR, which are required to be sent to the Authorities at the stipulated intervals.
Important changes for business with Switzerland
Since Switzerland is no longer abiding by the full regulations of the MDR, Swiss manufacturers must appoint a European Authorized Representative to export their devices to Europe. At the same time, European Manufacturers must designate a Swiss Authorized Representative to export their products to Switzerland, in compliance with the Switzerland Medical Device Ordinance (MepV, SR 812.213, entry into force on 26 May 2021). The Swiss Authorities have communicated the transition periods for the Swiss-Rep as until December 31, 2021, for class III and IIb medical devices, March 31, 2022, for class IIa and IIb medical devices, and July 31, 2022, for class I, systems and procedure packs.
In summary, this webinar helped to answer some burning questions with regards to the full implementation of the MDR and its implications to the medical devices imported or exported from Switzerland. Besides, Dr. Hofer's detailed explanations of the requirements set by the MDR on the PMS system, especially the PMCF reporting, proved to be very enriching for manufacturers in the final stages of preparing documentation for full compliance with the MDR. It was stressed that manufacturers should always consult pertinent MDCG guidance carefully in the course of preparing the PMS reports, especially when it comes to legacy devices.
If you are interested in joining us in our next webinar sessions about the EU, be sure to stay tuned to QT’s monthly newsletters for the announcements.