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 28th 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 products manufacturers in Brussels – heart

• f EU regulatory environment!

The voice of the contact lens and lens care products manufacturers in Brussels – heart

• f EU regulatory environment!

Composition of RAFG and sub-groups

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

Timeline for Medical Devices Regulation

25 May 2017 Entry into force

• f MDR

26 May 2020 Full application

• f MDR

Today 28 April 2018

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). 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). 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. 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. 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
• f 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!