Article 117 A Notified Body perspective, advice on how and when to engage notified bodies
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1 TOPRA Annual Medical Devices Symposium 2017 Article 117 A Notified Body perspective, advice on how and when to engage notified bodies Theresa Jeary, Head of Notified Body Medical Devices, LRQA ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
2 Presentation objectives Combinations of medical devices and medicinal products in Europe Background to Article 117, current reviews Impact of the MDR and Article 117 details ; An introduction to Notified Bodies; How to engage the services of a Notified Body; Documentation expectations to allow NB assessment of a medicinal product with integral device;
3 Combination Products in the EU
4 Current requirements for a medicinal product with integral device The Medical Device Directive states in Article 1, (3); Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 2001/83/EC (1), that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product. If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 2001/83/EC. The relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned. However No text contained in Directive 2001/83/EC; No details on what was expected and how the assessment to Annex I of MDD was to be conducted; Result = A gap in legislation
5 Notified Body experience of medicinal products with integral device under the MDD A Notified Body could not issue a CE Certificate for such a combination Regulated as a Medicinal Product; But Notified Bodies do have a broad range of expertise, familiar with drug delivery devices; Some Notified Bodies do provide a assessment report for such devices on the condition that the report is provided in full and sufficient detail to allow the Medicines Agency Assessment Team consider the information and make their own assessment ; Many concern s with current legislation; Technological advancements in the device area = the delivery devices is no longer just a simple container closure system Medicinal product Manufacturers may not be aware of the MDD or have internal expertise to know what documentation is required to demonstrate conformance to the Annex I Essential Requirements Varying level of scrutiny applied by Competent Authorities to such products
6 Medical Device Regulation Impact MDR, Article 1.8, 1.9 and Article 117 Amendment of the Annex I of Medicinal Product Directive 2001/83/EC Where a product is governed by MPD, the marketing authorization dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements of Annex I of MDR contained in the manufacturer s EU declaration of conformity or the relevant certificate issued by a Notified Body allowing the manufacturer to affix a CE marking to the medical device If the dossier does not include the results of the conformity assessment and where for the conformity assessment of the device, if used separately, the involvement of a Notified Body is required, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements of Annex I of MDR issued by a Notified Body designated in accordance with MDR for the type of device in question
7 What is a Notified Body?? Private, independent testing or certification organisation Provide conformity assessment services for many different EC Directive products Designated by their National Competent Authority Member States are not obliged to appoint any NB but can appoint several Mostly commercial business, some not for profit organisations / charitable foundations Medical device Notified Bodies have been assessed against the requirements of 93/42/EC and 920/2013/EEC Following medical device scandals - Notified Bodies have had to restore confidence in the process.
8 Notified Bodies Current Situation Current state of play post joint audits Scope for 93/42/EEC Medical Devices 53 reduced from >80 Scope for 90/385/EEC Active implantable medical devices 15 reduced from 18 Scope for 98/79/EC In vitro diagnostic medical devices 22 reduced from 26
9 Challenges for Notified Bodies as a result of joint audits Significant increase in number of Clients Significant increase of NB staff needed in all areas Training of new NB staff Technical expertise In-House Clinician requirements Impact = Timelines for Certification and NB Service has changed
10 Be aware of MDR Impacts for Notified Bodies Notified Bodies have to apply for designation against the Regulation Application can commence from 26 Nov 2017 Work ongoing in all NBs to ensure their processes shall meet the requirements of the new regulation Designation timescale against the Regulations Management of a duel system during transition No Grandfathering - all Medical Device Manufacturers shall need to apply for CE Certification against the MDR
11 How do I find a Notified Body? Designation and details are publically available at
12 Documentation Expectations for a Drug Delivery Device Scientific data to demonstrate conformance to the General Safety and Performance Requirements detailed in Annex I of the MDR Common sense requirements relating to safety and performance of the device Split into General Requirements & Requirements regarding Design and Manufacture
13 NB Assessment Report? The product approval is ultimately determined by the Medicines Agency who shall take into consideration all the evidence provided Important that the NB assessment report provides sufficient details to the Medicines Agency of what the NB has assessed and details the conclusion re suitability of conformance to Annex I to enable an informed assessment Important for NBs to engage with Medicines Agencies to understand their perspective to facilitate the process.
14 Advice for Manufacturers impacted by Article 117 Still some practical details unknown Quality System expectations? Legacy product assessment requirements? Anticipate Guidance shall be published
15 Impacted by Article 117? You have already taken the first important step.. Communicate with stakeholders Commence discussions with NBs Get involved in the discussions and forums
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18 Theresa Jeary Head of Notified Body Medical Devices Phone: +44 (0) Mobile: +44 (0) Web Address: ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
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