MDR impact on contact lens Manufacturers by Antonieta Lucas, Chair - PowerPoint PPT Presentation

MDR impact on contact lens Manufacturers by Antonieta Lucas, Chair of RAFG @ EFCLIN Congress 28 th April 2018 Dubrovnik

Disclosure • Antonieta Lucas • Alcon - Manager, Regulatory Affairs & EMEA RA Policy • Chair of EUROMCONTACT RAFG since December 2015 • Member of RAC MedTech Europe • Member of COCIR RA PA WG • President of APORMED – Portuguese MD Trade Association

Presentation - Who we are - MDR – timeline - Main elements of MDR for CL manufacturers - Technical documentation - Clinical evidence - Euromcontact work on clinical file - Post-market surveillance - UDI - Euromcontact work on UDI - New labelling requirements for contact lens - Other elements - Euromcontact RAFG – at a glance

Who we are The voice of the contact lens and lens care The voice of the contact lens and lens care products manufacturers in Brussels – heart products manufacturers in Brussels – heart of EU regulatory environment! of EU regulatory environment!

Composition of RAFG and sub-groups REGULATORY AFFAIRS FOCUS GROUP REGULATORY AFFAIRS FOCUS GROUP SUB- SUB- SUB- SUB- SUB- SUB- GROUP GROUP SUB-GROUP SUB-GROUP GROUP GROUP GROUP GROUP EUDAMED EUDAMED VIGILANCE VIGILANCE CLINICAL CLINICAL C&B C&B & UDI & UDI Sub-groups reports to RAFG. EFCLIN represented in RAFG, Sub-group clinical, EUDAMED & UDI EFCLIN represented in RAFG, Sub-group clinical, EUDAMED & UDI

Timeline for Medical Devices Regulation 26 May 2020 25 May 2017 Full application Entry into force Today of MDR of MDR 28 April 2018 Devices placed on the market under MDD before MDR date of application may Devices placed on the market under MDD before MDR date of application may continue to be made available for 5 years of the Date of Application (2025) . continue to be made available for 5 years of the Date of Application (2025) . Certificates issued under MDD after the MDR entry into force are valid for max 5 Certificates issued under MDD after the MDR entry into force are valid for max 5 years but void at latest 5 years after date of application. years but void at latest 5 years after date of application. Certificates issued under MDD before MDR entry into force are valid max. 5 years. Certificates issued under MDD before MDR entry into force are valid max. 5 years.

Main elements of MDR for CL and LCP manufacturers  Stricter requirements for technical documentation;  Reinforcement of the rules of clinical evaluation ( performance evaluation) and clinical investigation (performance studies);  Non-corrective CL are in the scope (Annex XVI);  Introduction of UDI system;  Additional requirements on NB leading to NB capacity issue and resources issues for manufacturers;  New obligations for manufacturers / liability in case of damages to patients.

Technical documentation: stricter requirements  MDR described for the first time, format of technical documentation; - Annex I ‘General safety and performance requirements’ replace the MDD Essential Requirements; - NB will expect re-evaluation of compliance with Annex I and evidence of this re-evaluation; - Annex II tech file; - Still delay in publishing references for standards (Annex Z). Impact for you! :  Need to review the data and documentation to justify compliance;  Resources: legal obligation to have a qualified person;  Resources: costs associated to NB;  Resources: fewer NB – SMEs priority for NB? Talk to your NB! Do not wait to be contacted!  Resources: EUROMONCONTACT SURVEY

Clinical evaluation and investigation: tighter requirements  MDR is more specific about clinical evidence and clinical evaluation ;  Restrictions on clinical evidence based on literature route;  manufacturers shall demonstrate they have access to the data on the device for which they are claiming evidence; Additional clinical data is required. Impact for you!:  NB interpretation of Meddev 2.7.1/rev4 as binding document;  NB interpretation of MDR already applying – i.e. equivalence;  Expect additional scrutiny from NB;  Costs of clinical trials, and evaluation  EUROMCONTACT CLINICAL DOCUMENT & EUROMCONTACT LOBBYING AT CEI WG

Euromcontact work on clinical file  Influence the process : - Euromcontact member of the WG on clinical evaluation and investigation; - 3 streams of work : legacy products; sufficient clinical data; concept of equivalence ; - Guidelines documents to be ready by Q3 2018 for CA, NB and manufacturers; - Euromcontact help shape for class IIa and IIb MD.  Help the members : - Euromcontact Clinical evaluation and investigation document reviewed in 2017/2018 to be in line with Meddev 2.7.1 rev 4 and MDR; - Will be Available!

FOCUS ON EUROMCONTACT CLINICAL DOCUMENT External Expert Consultant In line with MDR and MedDev 2.7.1/Rev4 Two parts/ literature review + own data from manufacturer Sections:  Presbyopia  Astigmatism  Myopia  Keratoconus  Ortho-K  Hybrid Lenses  Cosmetic Lenses

Post-market surveillance  Annex III post-market surveillance : active role of manufacturers to establish, plan monitor and update a PMS;  Shall be an integral part of the QMS of the manufacturer and need to foresee corrective actions;  Change of MIR form;  Reduced timeline from 30 days to 15 days for reporting serious incidents;  Periodic safety update report – annually for class IIb. Impact for you! :  Resources/ costs – Need to Plan

EUDAMED – UDI  Eudamed - Accessible to CA; NB; Manufacturers and some parts available to the public  UDI - Basic UDI-DI is the main key in the database and relevant documentation; - Any Basic UDI-DI shall identify the devices (group) covered by that Basic UDI-DI in a unique manner; - It is independent/separate from the packaging/labelling of the device and it does not appear on any trade item; - All tech files and certificates shall include Basic UDI-DI; - A UDI-DI shall be associated with one Basic UDI-DI;

Euromcontact work on UDI  Member of the WG on Eudamed UDI;  Lobbied for recognition of specific cases such as CL;  Success with reduction of Basic & UDI-DI numbers; awareness of COM + MS that specific cases for specific MD such as CL soft and made to order and IOL. Impact for you!:  Ressources and costs;  Labelling.

New requirements for labelling  MDR Annex I Section 19: specific details for label and for sterile packaging;  UDI;  Date of manufacture;  Indication that this is a Medical device;  If contains CMR shall be labelled;  Information shall be made available and kept up-to-date on the website of manufacturers. Impact for you!:  Plan!

Other elements to consider  Liability: manufacturers must be able to provide sufficient financial coverage for their potential liability (liability insurance);  OBL/OEM requirements: under MDR OBL is required to have full access to product technical documentation supporting the conformity assessment for CE-marking;  Additional personnel: under MDR it is legally binding to designate a regulatory compliance person. Impact for you!:  Resources/ costs;  Availability of skilled people;  Contract manufacturers may not continue supply if they have to made documentation (Tech File) available.

Euromcontact action  Industry member of all WG of the Commission;  Can help shape regulatory environment;  Can draw the attention of Regulators to specific needs for SMEs  Can help transfer flow of information to members;  RAFG meets 4 times a year + TC when needed;  Pool of experts per field (clinical/ vigilance/ C&B, etc.).

Questions? Thank you for your attention!