Accreditation & Designation of NB

Transcription

1 Accreditation & Designation of NB Bert Roossien Medical Devices Notified Body BSI Netherlands 07 June 2018 Copyright 2018 BSI. All rights reserved MDF1200 (EU) No 920/2013 In particular, they shall not offer or provide or have offered or provided, during the last three years, consultancy services to the manufacturer, his authorised representative, a supplier or a commercial competitor as regards Union requirements for the design, construction, marketing or maintenance of the products or processes under assessment. IMDRF/MDSAP WG/N3 FINAL:2016 In particular, they shall not offer or provide consultancy services to the manufacturer, his authorized representative, a supplier, or a commercial competitor, as regards to the design, manufacture or construction, marketing, installation, use or maintenance/servicing of the medical device or processes subject to audit; (EU) 745/2017 & (EU) 746/2017 In particular, they shall not offer or provide consultancy services to the manufacturer, its authorised representative, a supplier or a commercial competitor as regards the design, construction, marketing or maintenance of devices or processes under assessment 2 1

2 BSI Impartiality Policies 3 This Presentation 1. New MDR EU-Commission Press Release 2. Designation NB MDR / IVDR 3. The clock is ticking! 4. Brexit 5. Accreditation 6. Designation BSI-NL: MDD / AIMD / IVDD 7. Designation BSI-NL: MDR / IVDR 8. Next Steps. 4 2

3 Medical Devices Regulation (EU) 2017/745 & (EU) 2017/746 of April 5, 2017 Published Off Journal of the European Union May 5, 2017 The EU Commission welcomes the adoption of its proposal for two Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety. The new Regulations on medical and in-vitro diagnostic medical devices proposed by the Commission in 2012 will help to ensure that all medical devices - from heart valves to sticking plasters to artificial hips are safe and perform well. To address this, the new rules will improve market surveillance and traceability as well as make sure that all medical and in vitro diagnostic devices are designed to reflect the latest scientific and technological state-of-the art. The rules will also provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation in this strategic sector. 5 Medical Devices Regulation (EU) 2017/745 & (EU) 2017/746 Elżbieta Bieńkowska, Commissioner for Internal Market, Industry, Entrepreneurship and SMEs, said: "I'm extremely happy that our push for stricter controls of medical devices on the EU market will now become a reality. Whether for medical devices, cars or other products, we must ensure stronger supervision in the interest of our citizens. We should not wait for another scandal instead we should start a discussion how to strengthen European oversight over Member States' market surveillance activities." The two new Regulations bring a number of improvements for medical and in-vitro devices: Improve the quality, safety and reliability of medical devices: The new rules will impose tighter controls on high-risk devices such as implants, requiring a pool of experts at the EU level to be consulted before placing the device on the market. Controls will also be tightened on clinical trials. Controls will also be tightened on the bodies that can approve the marketing of medical devices. The new rules will also cover certain, previously unregulated aesthetic products (e.g. coloured contact lenses that do not correct vision). In addition, a new system for risk classification in line with international guidelines will apply to in vitro diagnostic medical devices. Strengthen transparency of information for consumers: The new regulations will make sure that vital information is easy to find. For instance, patients will receive an implant card with all the essential information, and a unique device identifier will be mandatory for every product so that it can be found in the new European database of medical devices (EUDAMED). Enhance vigilance and market surveillance: Once devices are available for use on the market, manufacturers will be obliged to collect data about their performance and EU countries will coordinate more closely in the field of market surveillance. 6 3

4 The new Regulations in a nutshell The new Regulations contain a series of extremely important improvements to modernise the current system. Among them are: the reinforcement of the criteria for designation and processes for oversight of Notified Bodies stricter ex-ante control (on beforehand) for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level, the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous MD under the scope of these Regulations, the introduction of a new risk classification system for in vitro diagnostic MD in line with international guidance, improved transparency through the establishment of a comprehensive EU database on MD and of a device traceability system based on Unique Device Identification, the introduction of an implant card containing information about implanted MD for a patient, the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations, the strengthening of post-market surveillance requirements for manufacturers, improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance, More information is available in this presentation that contains general information on key changes contained in 7 the Regulations and transitional periods. Background There are over 500,000 types of medical devices and in-vitro diagnostic medical devices on the EU market. Examples of medical devices are contact lenses, x-ray machines, pacemakers, breast implants and hip replacements and sticking plasters. In vitro diagnostic medical devices, which are used to perform tests on samples, include HIV blood tests, pregnancy tests and blood sugar monitoring systems for diabetics. The existing regulatory framework dates back to the 1990s and consists of three Directives. However, problems with divergences in the interpretation and application of the rules, technological progress as well as incidents involving malfunctions of medical devices i.e. the PIP breast implant scandal- highlighted the need for revision of current legislation. The Commission is also currently working on more structural and horizontal solutions for better market surveillance within the broader frame of a goods package reform. To address this, the European Commission presented two legislative proposals on medical and in-vitro diagnostic on 26 September This was followed by extensive expert consultations that resulted in an agreement on the general approach to the medical devices package among Member States' health ministers on 5 October The adoption of the package by Parliament, following today's vote in plenary, fully reflects the position of the Council reached in its first reading and in turn the agreement of the co-legislators from June 2016, therefore allowing to conclude the legislative process. To allow manufacturers and authorities to adapt, the new rules will only apply after a transitional period, namely 3 years after publication (26 May 2020) for the Regulation on medical devices and 5 years (26 May 2022) after publication for in the Regulation on vitro diagnostic medical devices. 8 4

5 Notified Bodies Situated in any Member State* Conduct Conformity Assessment 9 Designation: For the Medical Devices Directives, the Regulation (EU) 920/2013 and the accreditation standard EN-ISO/IEC form the basis of designation requirements to demonstrate competence as a Notified Body. Additionally there are requirements laid down by Competent Authorities, Notified Body / Competent Authority groups and the European Commission. (AIMD Annex 8; MDD Annex XI; IVD Annex IX, Designating Auth A Handbook 2000; MEDDEV 2.10 (2001) Accreditation for Assessment Activities per IAF-MD and ISO Management Systems (e.g. scope ISO 13485) are granted by Certification and made public on the website of the Accreditation Services. AIMD ANNEX 8 MINIMUM CRITERIA TO BE MET WHEN DESIGNATING INSPECTION BODIES TO BE NOTIFIED (1 page; 7 requirements) MDD ANNEX XI CRITERIA TO BE MET FOR THE DESIGNATION OF NOTIFIED BODIES (1 page; 7 requirements) IVDD - ANNEX IX CRITERIA FOR THE DESIGNATION OF NOTIFIED BODIES (1 page; 7 requirements) Designations are announced by publication in the Official Journal of the European Communities and its scope of Designation is maintained on the European Commission New Approach Notified and Designated Organisations Information System (NANDO) web site Designation: For the Medical Devices Regulations, the Regulation (EU) 2017/745 and (EU)2017/746 and the accreditation standard EN-ISO/IEC form the basis of designation requirements to demonstrate competence as a Notified Body. Additionally there are requirements laid down by Competent Authorities, Notified Body / Competent Authority groups and the European Commission. MDR & IVDR - ANNEX VII REQUIREMENTS TO BE MET BY NOTIFIED BODIES 1. ORGANISATIONAL AND GENERAL REQUIREMENTS 2. QUALITY MANAGEMENT REQUIREMENTS 3. RESOURCE REQUIREMENTS 4. PROCESS REQUIREMENTS Total: 17 pages of Requirements 10 5

6 MDR & IVDR - Annex VII requirements to be met by Notified Body 1] Organisational & General Requirements 2] Quality Management Requirements 3] Resource requirements 4] Process Requirements Increase & New Competency Codes QMS & TS N=1 N=14 MD0100 General non-active, nonimplantable MD0200 Nonactive implants MD0300 Devices for woundcare MD0400 Nonactive dental device MDN1200 MDN1100 MDN1200 MDN1200 6

7 Add 4] Process Req: NB to adjust Conformity Assessment Quality System Audits Unannounced Audits ISO is the tool used to conduct a QMS audit Microbiology & Sterilisation Audits Technical Documentation Reviews ISO certificates are not mandatory for EU manufacturers MDR Transition (Article 120) Entry into Force (OJEC + 20days) (25 May 2017) Date of Application (26 May 2020) 27 May 2025 No more «placing on the market» of devices covered by MDD/AIMD certificates 05 May 2017 Adoption of MDR Transition period 3 years MDD/AIMD certificate validity (4 years ) Annex IV certificates expire (27 May 2022) MDD/AIMD certificates (max 5-year expiry from issue/renewal date) MDR certificates Last MDD/AIMD certificates expire (27 May 2024) NBs designation under MDR 14 7

8 15 The Clock is Ticking! What products currently on the EU market? What products on the market post 2024? What needs certification in 2022 / 2024? What is in the MDR / IVDR that wasn t previously? i.e. Will need CE Certification sooner? What is reclassified? What are the priority products? 16 8

9 17 BREXIT 18 9

10 BSI Conformity Assessment BSI-UK & BSI-NL Quality System Audits Unannounced Audits BSI-UK & BSI-NL Independent Organizations with: Microbiology & Sterilisation Audits Technical Documentation Reviews Identical QMS Processes Identical Competence Each with required Internal staff BSI NL: Internal Personnel 20 10

11 Independent Notified Bodies: (EU) 920/2013 & MDR/IVDR Annex VII 21 BSI-NL: RVA Accreditation RVA Accreditation approved (April 30, 2018) - BSI-NL s Extension to Scope of EN-ISO/IEC :2015 to include assessments & certification for ISO Medical Devices Quality Management System 11

12 BSI-NL: Designation AIMD & MDD and.ivdd 23 BSI-NL: MDR Designation Directives & Regulations Joint Assessment MD & AIMD 2019 Joint Assessment IVDR 2018 Joint Assessment MDR 2021 Joint Assessment MDR 2022 Joint Assessment IVDR 2023 Joint Assessment Regulation Joint Assessments then every 4 years Year -3 Year -2 Year -1 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Publication Entry into Force Adoption MDR Date of Application IVDR Date of Application 12

13 3.4 Status Designation as a Med Dev NB for MD Regulations (MDR & IVDR) BSI Medical Devices Schemes Based on QMS Assessment 26 13

14 Two Notified Bodies: BSI-UK (0086) BSI-NL (00xx) NEXT STEPS for Mft. 27 Information for Users SPR#23 (e) medicine, human, animal (f) CMR + ED >0.1% (j) (o) reprocessing cycles (a) (g) (c) (s) (d) manufacturers don't need to relabel products which have already been placed on the market to refer to the new NB number, since the old number can still be traced in NANDO. (p) custom made (q) clinical investigation (r) quantity of constituents achieving principal intended action (b) (l) (k) (n) (m) (i) (h) *Article

15 Contracts and Certificates 29 Goals and Objectives Migrate some Medical Devices certificates to new NB NL while maintaining the historical accuracy of data previously held under NB 0086 and operate both NBs in parallel Adherence to current assessment visit schedules during any certificate migration Robust and seamless continuation of Medical Devices operations throughout transition Copyright 2018 BSI. All rights reserved 30 08/06/

16 Questions & Answers 31 16

17 IVDR Transition (Article 110) Entry in to Force 25 May 2017 Date of Application 26 May 2022 IVDD certificates void 27 May May 2017 Adoption of IVDR Transition period 5 years IVDD certificate validity (2 years ) 27 May 2025 IVDD certificates can be issued/re-issued/renewed No more «making available or putting into service» of devices covered by IVDD certificates NBs can apply for designation 26 Nov 2017 NBs designation under MDR IVDR certificates 33 17