Preparing for the new Regulations for healthcare providers

Transcription

1 Preparing for the new Regulations for healthcare providers Cathal Brennan, Medical Device Assessor HPRA Information Day on Medical Devices 23 rd October 2014

2 Brussels, COM(2012) 542 final 2012/0266 (COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 The choice of a Regulation, How however, does not mean that decision-making is centralised. Member States retain their competence for implementing the harmonised rules. The proposed revision of the existing directives, which will integrate the changes introduced by the Lisbon treaty regarding public health, can be achieved only at Union level. This this is necessary in order to improve the level of protection of public health for all European patients and users. The proposal affects the freedom of economic operators to conduct business (Article 16) but the obligations imposed on manufacturers, authorised representatives, importers and distributors of medical devices are necessary to guarantee a high level of safety of those products. Transparency and better information are essential to empower healthcare professionals? and to enable 22/10/2014 2

3 Aims of the Regulations.to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation. Transparency and better information are essential to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system. Slide 3

4 Manufacturing within health institutions Medical Device Regulation Chapter II A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose. Article 4 (1) Devices that are manufactured and used within a single health institution shall be considered as being put into service. The provisions regarding CE marking referred to in Article 18 and the obligations laid down in Articles 23 to 27 shall not apply to those devices, provided that manufacture and use of those devices occur under the health institution's single quality management system. Article 4 (4). Slide 4

5 Manufacturing within health institutions IVD Regulation Chapter II Devices that are manufactured and used within a single health institution shall be considered as being put into service. Article 4 (4) Devices classified as class D in accordance with the rules set out in Annex VII, even if manufactured and used within a single health institution, shall comply with the requirements of this Regulation. However, the provisions regarding CE marking set out in Article 16 and the obligations referred to in Articles 21 to 25 shall not apply to those devices. Article 4 (5) With the exception of Article 59(4), the requirements of this Regulation shall not apply to devices classified as class A, B and C, in accordance with the rules set out in Annex VII, and manufactured and used only within a single health institution, provided manufacture and use occur solely under the health institution's single quality management system, and the health institution is compliant with standard EN ISO or any other equivalent recognised standard. Article 4 (5) Slide 5

6 Manufacturing within health institutions Medical Device Regulation Chapter II, Article 20 on Systems and Procedure Packs Any natural or legal person shall draw up a statement referred to in paragraph 2 if he puts devices bearing the CE marking together. in accordance with the intended purpose of the devices. in order to place them on the market as a system or procedure pack Any natural or legal person who sterilises systems or procedure packs referred to in paragraph 1 for the purpose of placing them on the market shall, at his choice, follow one of the procedures referred to in Annex VIII or in Part A of Annex X. Slide 6

7 Manufacturing within health institutions Medical Device Regulation Chapter II, Article 21 on Parts and components An article that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics of the device shall be considered a device. Slide 7

8 Obligations of manufacturer Chapter II, Article 14 A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if he does any of the following: (a) makes available on the market a device under his name, registered trade name or registered trade mark; (b) changes the intended purpose of a device already placed on the market or put into service; (c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected Does not apply where, in order to market the product: Provision, including translation, of information supplied by manufacturer Changes to outer packaging (pack size) Slide 8

9 Reprocessing single use devices Current Directive Does not include specific provisions for the reprocessing of single use medical devices or specific responsibilities or definitions of entities who were potentially reprocessing single use medical devices. Chapter II, Article 15 of Medical Device Regulation The re-processor of the device becomes the manufacturer Only validly CE-marked device may be reprocessed Safety of reprocessing devices for critical use, assigned by the Commission, must be assessed Label & IFU must include re-processor details Label no longer to include original manufacturer s name but appears on IFU National Regulations may be invoked to prohibit reprocessing of singleuse devices and/or their supply. Slide 9

10 The Importance of Traceability

11 How do we avoid this?

12 Unique Device Identification Chapter III Article 24 Requirements of the UDI System: Production of UDI (DI + PI) Placement of UDI on label of device Establishment of electronic system on UDI Health institutions shall store and keep, by electronic means, the device identifier and the production identifier of the devices which they have been supplied with The Commission, in cooperation with the Member States, shall set up and manage an electronic system on UDI to collate and process the information. Accessible to the public. UDI shall be used for reporting serious incidents and field safety corrective actions and included in patient implant card Slide 12

13 European UDI Database: UDI No; DI data only Mfr Distr Hosp UDI No. DI: PI: To: UDI No. DI: PI: From: To: UDI No. DI: PI: From: To:

14 Registers Chapter VIII Article 83; National Device Registers The Commission and the Member States shall take all appropriate measures to encourage the establishment of registers for specific types of devices to gather post-market experience related to the use of such devices. Such registers shall contribute to the independent evaluation of the long-term safety and performance of devices. Slide 14

15 Implant Cards Chapter II Article 16 The manufacturer of an implantable device shall provide together with the device an implant card which shall be made available to the particular patient who has been implanted with the device. This card shall contain the following: (a) the information allowing identification of the device, including the Unique Device Identification; (b) any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences or environmental conditions; (c) any information about the expected lifetime of the device and any necessary follow-up. Proposals to include information on procedure and health institution Slide 15

16 Clinical Performance & Investigations Chapter III Article 26 In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance. Clinical Investigations Discussions around inclusion of non-commercial investigations Site inspections Notification of post-market clinical studies Slide 16

17 Vigilance reporting Chapter VII (Article 61 (3)) o The Member States shall take all appropriate measures to encourage healthcare professionals, users and patients to report to their competent authorities suspected serious incidents o Obligations to report incidents and FSCAs apply to in-house manufacturing (Chapter II, Article 4(4)) o Electronic system on Vigilance (article 62) - EU portal for manufacturers to notify of incidents, FSCA s and PSR s o Periodic summary report (Article 61 (2)) o Trend Reporting (Article 64) Slide 17

18 EUDAMED EUDAMED 2 3 (Data stored in (Data the European stored in the MD future databank) European MD databank) Electronic System on Registration Information on devices and Economic operators. Electronic System on Certificates Electronic System on Clinical Investigations Electronic System on Vigilance Electronic System on market surveillance Information on measures taken by MS in case of: Non-compliant devices presenting a risk to health and safety; Compliant products presenting a risk to health and safety; Electronic System on Unique Device Identification (UDI) Information on: DI data elements Formal non-compliance of devices; Preventive health protection measures.

19 Proposed EUDAMED Registration (Article 25): Enables the public to be adequately informed on device availability & economic operators on the market. Publicly Accessible Certificates (Article 45(4)): Enabling the public to be adequately informed on Certificates on the market. Publicly Accessible Clinical Investigations (Article 53): Enabling single application from sponsors for CIVs in more MS & ensuring cooperation between MS. Publicly Accessible (subject to confidentiality restrictions)

20 Proposed EUDAMED Vigilance (Article 61): Enabling manufacturers reporting of serious incidents and other events & supporting coordination of their assessment by NCAs. Accessible to MS, COM & NB (partly accessible to the public and HCP) Market Surveillance (Article 68): Ensuring the exchange of information between NCAs. Accessible to MS & COM UDI (Article 24): Identification and traceability of medical devices Publicly accessible

21 Qualification and Classification Extension of the scope Certain implantable or other invasive products without a medical purpose that are similar to medical devices in terms of characteristics and risk profile Classifications o Non-corrective contact lenses, o implants for aesthetic purposes e.g. dermal fillers Aphaeresis machines have been moved from class IIb to class III. Devices that are composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body are in class III. Slide 21

22 Summary Regulations will provide improved transparency and better information to Health care professionals and users provide clarification on the role of healthcare institutions provide clarification on certain practices provide a high level of safety and health to patients and users Discussions are ongoing HPRA will communicate updates on Regulations and develop guidance Slide 22

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