Clusters working group COM/CAMD New Regulations The European Association Medical devices Notified Bodies Clusters working group COM/CAMD New Regulations Team-NB-WG-newRegulation-Clusters-priorities-20170309

Team-NB-WG-newRegulation-Clusters-priorities-20170309 Notified bodies Designation Process Establish a clear process for NB submission (from application to designation) It must be ensured, that users and European patients will continuously be provided with medical devices they need. This includes an established and clear process for the entire Notification process, from the application to final publication in NANDO. Transition: What is a significant change to a device or system? This might become important during the extension of the transition periode after EIF. Conformity Assessment Procedures As a Notified Body one of our main task is described in Conformity Assessment Procedures. We do not see this covered as a part of the 7 clusters. Guidelines or delegated acts are needed to ensure harmonized assessments of Technical documentation, especially after the initial audits as part of the surveillance activities Definition of technical documentation sampling and aspects related to unannounced audits (art. 42) needs clarification and a harmonized approach across Europe. Reduction of Technical Documentation assessment to the clinical evaluation appears worth for further clarification to ensure consistent assessment. Team-NB-WG-newRegulation-Clusters-priorities-20170309 Team-NB-WG-newRegulation-Clusters-priorities-20170309

Team-NB-WG-newRegulation-Clusters-priorities-20170309 Market Surveillance Transparency The system of market surveillance carried out by the CA, Commission, MDCG, and NB shall be transparent and defined. The responsibilities and communication between the involved parties shall be clearly defined. In addition, the whole escalation cascade shall be clearly defined as well. Communication The rules for communication and NB’s responsibilities of incidents occurring outside the EU shall be detailed. Screening of incident reports, FSCA, FSN FDA by the Notified Bodies should focus on the EUDAMED database and not on further databases available around the world, e.g. FDA MAUDE. Communication between the various regions should clearly described and implemented by tools as part of EUDAMED. Team-NB-WG-newRegulation-Clusters-priorities-20170309

Team-NB-WG-newRegulation-Clusters-priorities-20170309 UDI Use of Basic UDI-DI Is the UDI-DI definition “broad” enough to avoid permanent updates of certificates or in relation to the requirement of assessing all technical documentations for class IIb implantable devices? Validation Process for EUDAMED data UDI is pretty much linked to device registration. The validation process of such data by a Notified Body will be very high, depending on the details of the definition of the Basic UDI code. This task could be not possible for Notified Bodies, especially for devices covered by a quality system related certificate. Team-NB-WG-newRegulation-Clusters-priorities-20170309

Classification & Scope Availability of Scope Definition The scope definitions needed for the application of notified bodies under MDR and IVDR have to be available as soon as possible Classification Software classification appears to differ from international classification Classification of Implants coming into contact with the spinal cord are even now pretty much under discussions with very different results Team-NB-WG-newRegulation-Clusters-priorities-20170309

Team-NB-WG-newRegulation-Clusters-priorities-20170309 PMS & Vigilance EUDAMED MDR According to Article 33/30 (European databank on medical devices) §8, implementing acts which lay down the modalities necessary for the development and management of EUDAMED are expected. The use of EUDAMED will be a key part of the certification process according to the MDR/IVDR, for the assessment of the PMS/vigilance control by manufacturers. NB shall search for or upload information. The access and modalities for the NB to EUDAMED shall be clarified and established when the first NB will be designated. Periodic activities by Notified Bodies According to Article 91/86 (Implementing acts) §b and d, implementing acts which lay down the modalities (contents and timelines) necessary for, among other, field safety notices, periodic summary reports, post-market surveillance reports, periodic safety update reports and trend reports are expected. The review of these reports will be a key part of the certification process. Their detailed content and instructions shall be clarified and established in order for NB to properly access them, when the first NB will be designated. Team-NB-WG-newRegulation-Clusters-priorities-20170309

Team-NB-WG-newRegulation-Clusters-priorities-20170309 IVD Specificities Codes, nomenclature Clarity on the NBOG codes for IVD under the IVDR is urgent even if the MDR has a longer transition periode This is important as we as Notified Nodies are asked to apply for both regulations at the same time – if possible. IVDR: Class B and C Conformity assessment for Class B and Class C devices, specifically technical file sampling, needs further clarification right from the beginning. Team-NB-WG-newRegulation-Clusters-priorities-20170309

Team-NB-WG-newRegulation-Clusters-priorities-20170309 IVD Specificities IVDR following priorities Delegated - Implementing Act on designation of Reference Laboratories - This is required for the IVDR Notified Bodies to assess Class D IVD devices, check performance claims and batch testing; Conformity Assessment Process for Companion Diagnostics - requiring clear process and communication with Drug Authorities and Competent Authorities; Classification of IVDR devices – This is important for IVDR Notified Bodies to correctly determine classification and, ultimately the conformity assessment route; Conformity Assessment Process for IVDR Notified Body, depending on Classification; Clinical Performance Evaluation and Clinical Performance Studies – this is important since the IVDR now places a lot of emphasis on clinical evidence from new and existing IVD's; Team-NB-WG-newRegulation-Clusters-priorities-20170309

General topics and communication Assessment of clinical evaluation Assessment of clinical evaluation must be described in more details. Example: What does the word “sufficient” clinical data mean? This needs a definition to allow all manufacturers and NB’s to apply the same requirements. What do NB'S do with products for which the route of equivalency cannot be applied because access to the technical documentation of equivalent medical devices is often not possible? Transition to MDR/IVDR Notified Bodies need guidelines when to start with audits and assessments according to MDR, and whether such first audits and assessments can be conducts as upgrade audits/assessments instead of full initial audit/assessment. Team-NB-WG-newRegulation-Clusters-priorities-20170309

Contacts: www.team-nb.org Guy Buijzen (guy.buijzen@dekra.com) – president Hans Heiner Junker (hans-heiner.junker@tuev-sued.de) – vice president Kevin Butcher (kevin.butcher@sgs.com) – vice president Corinne Delorme (corinne.delorme@lne.fr) – secretary Alexey Shiryaev (Alexey.Shiryaev@presafe.com) - treasurer Françoise Schlemmer (schlemmer@quasys.com) -Director and Secretariat Members: Team-NB-WG-newRegulation-Clusters-priorities-20170309