R E C H T S A N W Ä L T E. Kaistraße 2 D Düsseldorf Telefon

Transcription

1 R E C H T S A N W Ä L T E Kaistraße 2 D Düsseldorf Telefon dierks@db-law.de

2 Who are we? Founded 1997 Offices in Berlin, Brussels and Düsseldorf Specialized in Health Care & Life Sciences 30 Attorneys, total staff 55 Law on Medical devices, medicinal products, market access, reimbursement, distribution, clinical trials, Pharmacy law, Hospital Law, Tender Law, Anti-trust and Data protection Law September 2014 Seite 2

3 Current Legal Framework for medical devices European Law Directive Implantable Devices (AIMDD) Medical Device Directive (MDD) In-Vitro Diagnostics Directive (IVDD) German Law Medical Product Law MPV MP BetreibV MPVertrV MP VerschrV MPSicherheits planv BKostenV- MPG DIMDI Verordnung September 2014 Seite 3

4 New Legal Framework for medical devices European Law Medical Device Regulation (MDR) Regulation on In-vitro-Diagnostica (IVDR) German Law Medical Product Law MPV MP BetreibV MPVertrV MP VerschrV MPSicherheits planv BKostenV- MPG DIMDI Verordnung September 2014 Seite 4

5 The PIP Scandal September 2014 Seite 5

6 CE-Certification = Precondition for placing MD on the German Market Unlike medicinal products (drugs): No marketing authorization required No production permit required Preconditions: Notification to Federal Institute (BfArM) CE-Mark Marketable throughout Europe (Art. 4 MDD) Security Officer September 2014 Seite 6

7 Preconditions for CE-Certification: Proof of functionability and security Basic Requirements of Annex I MDD Procedure of conformity assessment Proof of good manufacturing practice Ø development Ø production Ø packaging etc. Proof of good product continuity Ø Quality Assessment Procedure September 2014 Seite 7

8 8 Steps to Certification Risk Classification by Producer (I, IIa, IIb, III) Assessment of the efficacy by clinical evaluation on the basis of clinical trial or literature Deciding on the type of procedure of conformity assessment Compiling the technical documentation Approaching notified body Procedure of conformity by producer or notified body Submission of notification to official authority (BfArM) Attaching CE Mark This can be achieved in a couple of months! September 2014 Seite 8

9 Planned EU-Reformation of Legal Framework Current Status: 26. Sept. 2012: Drafts of MDR and IVDR 2. April 2014: First reading in EP Task force in European Council (EC) negotiates both drafts since October 2012 New elections of EP Next objective: Early second reading agreement in autumn 2014 September 2014 Seite 9

10 Planned EU-Reform Consistent notification and surveillance of notified bodies based on strengthened requirements Creation of a coordination group for MD (MDCG) consisting of experts of all member states Implementation of a scrutiny procedure for conformity assessment of high-risk MD by MDCG Strengthening of the rules for market surveillance and vigilance system Strengthening and specifying of the rules for clinical evaluation and clinical studies of MD September 2014 Seite 10

11 Planned EU-Reformation Rules for reprocessing of single-use devices Improvement of identification and implementation of a product traceability system via product-identification-number (UDI) Obligation on manufacturers for implant passports Extension of the database EUDAMED September 2014 Seite 11

12 Planned EU-Reformation Severe rules for high-risk-md (class III and IIb): Scrutiny procedure with new institutions ( coordination group on medical devices and assessment commitee for medical devices ) Special notified bodies September 2014 Seite 12

13 Regulation Content : Commission Proposals for new Regulations on Medical Devices, COM IVD, COM Regulations to replace the current 3 main directives 90/385/EEC Active implantable medical devices 93/42/EEC Medical devices Directive 98/79/EC In vitro diagnostic medical devices Perceived need by Commission for the revision: Overcome fragmentation of the current directives (different interpretation and implementation in Memberstates and too complicated in itself) Orientation towards international models ( GHTF -model) Enhance effective coordination and harmonization at EU level September 2014 Seite 13

14 Scope 1 Covers all medical devices other than in vitro diagnostic medical devices (Art. 1 (1)) Pricing and reimbursement are not in the scope of the new regulation The scope of the Regulation will be extended to products manufactured utilising non-viable human tissues or cells certain implantable or other invasive products without a medical purpose that are similar to medical device in terms of characteristics and risk profile, such as breast implants or contact lenses without a corrective purpose Products that contain viable tissues or cells of human or animal origin are already explicitly excluded from the medical devices legislation It is clarified that products that contain living biological substances of other origin are also not covered by the Regulation September 2014 Seite 14

15 Scope 2 Products composed of substances or combinations thereof that are intended to or inhaled and that are wholly or partly absorbed by or dispersed in the human body are in the scope of the Regulation but should comply, in analogy, with relevant requirements of Annex I of DIR 2001/83/EC (Art. 1 (4) and Annex I) Proposal also covers medical devices that incorporate medicinal products with action ancillary to that of the device (Art.1 (4)) Food covered by Regulation (EC) No 178/2002 on general principles and requirements of food law (e.g. slimming products) is not in the scope of the Regulation Medical devices are excluded from the scope of Regulation 178/2002 (diagnostic probes or cameras, even when introduced orally, are therefore clearly excluded from the food legislation) September 2014 Seite 15

16 New Obligations and Concepts Clear conditions for enterprises involved in relabelling and /or repackaging medical devices (Art. 14) full compliance with the provisions set out for manufacturers Patients must be given essential information on implanted devices allowing it to be identified and containing any necessary warnings or precautions to be taken (Art.16). Concept of sponsor is introduced: in practice often a contract research organisation conducting clinical investigations for the manufacturer (Art. 50 (2)) September 2014 Seite 16

17 Classification and Conformity Assessment The division into four classes is kept. The classification determines the applicable conformity assessment procedure (Art. 41, Annex VII): Class I: conformity assessment procedure can be carried out under the sole responsibility of the manufacturer; in case the device has a measuring function or is sold sterile, a notified body must verify the aspects related to the measuring function or the sterilisation process (Art.42) Class IIa, IIb: notified body checks the quality management system and, for representative samples, the technical documentation. After initial certification it has to regularly conduct surveillance assessments in the post-market phase (Art.42) Class III: Explicit prior approval of the design or of the type of the device and of the quality management system is required (Art.42, Annex VIII) September 2014 Seite 17

18 Classification and Conformity Assessment II Some classification rules have changed, regarding e.g. implantable devices, implants and surgically invasive devices, intended for direct contact with the heart, the central circulatory system or the central nervous system The Commission may determine by implementing acts specific categories or groups of medical devices that have to be treated as class III devices for conformity assessments; requirements for such measures are set out in Art. 44 and consist of protection of patient safety and public health reasons Custom-made devices: subject to a specific procedure laid down in Annex XI which does not involve a notified body High-risk devices: Obligation for notified bodies to notify an expert committee of new applications for the conformity assessment Certificates issued by the notified bodies confirm the assessment and are valid for maximum 5 years (Art. 45) September 2014 Seite 18

19 Requirements for manufacturers of medical devices I All medical devices have to comply with the essential safety and performance requirements set out in Annex I (Art. 4) Compliance with Annex I shall be demonstrated by a clinical evaluation according Art. 49 and Part A of Annex XIII Clinical evaluation must be carried out by the manufacturer throughout the life-cycle of the device, to demonstrate the safety and performance of the device (Art. 49) A requirement for a 'qualified person' is introduced who is responsible for regulatory compliance Manufacturers without a registered place of business in a Member State must designate an authorized representative (Art. 9) September 2014 Seite 19

20 Requirements for manufacturers of medical devices II Manufacturers/authorized representatives and importers and the devices which they place on the EU market must be registered in a central European database Manufacturers of high-risk devices (Class III and implantable devices) must make publicly available a summary of safety and performance with key elements of the supporting clinical data The regulatory instrument of common technical specification (CTS), known from the IVD context, is introduced in the broader field of medical devices to allow the Commission to further specify the essential safety and performance requirements (laid down in Annex I) and the requirements on clinical evaluation and post-market clinical follow-up (laid down in Annex XIII) September 2014 Seite 20

21 Requirements for manufacturers of medical devices III All medical devices other than custom-made or investigational devices must bear a unique device identifier (UDI) (Art. 24) to ensure identification and traceability of the device All medical devices other than custom-made or investigational devices must bear the CE marking of conformity which is subject to the general principles set out in Art. 30 REG (EC) No 765/2008 (Art. 18, Annex IV) September 2014 Seite 21

22 Notified Bodies The position of notified bodies is strengthened right and duty to carry out unannounced factory inspections conduct physical or laboratory tests on devices Rotation of the notified body's personnel involved in the assessment of medical devices Memberstates remain responsible for designating and monitoring notified bodies, based on criteria laid down in Annex VI (Art. 29) Commission assigns an identification number to each notified body for which the notification is accepted (Art. 34) September 2014 Seite 22

23 Clinical Evaluation Clinical evaluation (Art. 49) must be carried out by the manufacturer throughout the life-cycle of the device, to demonstrate the safety and performance of the device, based on critical evaluation of relevant scientific literature or results of all clinical investigations performed and the clinical data obtained from the implementation of the manufacturer s post-market surveillance plan September 2014 Seite 23

24 Clinical Investigation Clinical investigation must be carried out only for purposes provided for in Art. 50 (1): Efficacy, benefits, side effects Detailed requirements set out in Annex XIII for pre-market clinical evaluation and post-market clinical follow-up; continuous process during the life-cycle of a medical device Every clinical investigation must be registered in a publicly accessible electronic system, set up as part of Eudamed (Art. 52, 53) September 2014 Seite 24

25 Requirements for Clinical Investigation Sponsor must obtain a single identification number for every clinical investigation (Art. 51) Prior submission of an application to confirm that there are no health/safety /ethical aspects opposing the clinical investigation (Art. 51) Single electronic application for clinical investigations to be conducted in more than one MS (Art. 58) Joint assessment of health and safety aspects by the MS concerned under the lead of coordinating MS (Art. 58) Assessment of national, local and ethical aspects carried out at the level of each MS concerned; MS retains the ultimate responsibility for deciding whether the clinical investigation may be conducted on its territory MS define the organisational set-up at national level for approval for clinical investigations Thus clinical investigations rules for medical devices are aligned with those for clinical trials September 2014 Seite 25

26 Extension of European Databank Eudamed European databank on medical devices (Eudamed), set up by Commission Decision 2010/227/EU is extended It will contain data on UDI, registration of devices, certificates issued by notified bodies, clinical investigations (Art. 52, 53), vigilance and market surveillance Manufacturers must report serious incidents or corrective actions they have taken The information will be automatically forwarded to the national authorities concerned A large part of the information in Eudamed will become publicly available September 2014 Seite 26

27 Identification and Traceability Economic operators must be able to identify all participants of the distribution chain (Art. 23) Manufacturers are required to fit their devices with a Unique Device Identification (UDI) which allows traceability and identification (Art. 24) The UDI system will be implemented gradually and proportionate to the risk class of the devices The UDI will be comprised of A device identifier specific to a manufacturer and a device model A production identifier that identifies data related to the unit of device production September 2014 Seite 27

28 Transitional periods I Before entry into force of the Regulation: Certificates for medical devices issued in accordance with the directives on medical devices (DIR 93/42/EEC and DIR 90/385/EEC), will be valid until the expiration date indicated on the certificate Exception: Certificates issued for active implantable medical devices according to Annex 4 of DIR 90/385/EEC or for medical devices according to Annex IV of Directive 93/42/EEC become void at the latest two years after the date of application of this Regulation September 2014 Seite 28

29 Transitional periods II After entry into force of the Regulation: Certificates issued become void at the latest two years after the date of application of this Regulation Even before the date of the application of the new Regulation, devices can be placed on the market under the new rules Notified bodies which are designated in accordance with this Regulation may apply the conformity assessment procedures laid down in this Regulation and issue certificates Clinical investigations which have started to be conducted in accordance with Art. 10 of Directive 90/385/EEC or Art. 15 of Directive 93/42/EEC prior to the application of this Regulation may continue to be conducted. As of the application of this Regulation, however, the reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation. September 2014 Seite 29

30 Benefit assessment for MD? Actual benefit assessments for MD: Benefit-Risk-Assessment is precondition for market access (Annex X Directive 93/42/EWG; Annex 7 A Nr. 1 Directive 98/79/EG) Benefit-Assessment for catalogue of therapeutic appliances (section 139 SGB V) Benefit-Assessment for inpatient-sector by G-BA (sections 137c and 137e SGB V) September 2014 Seite 30

31 Benefit assessment for MD Future early benefit assessment for MD Class IIb and III Implementation of an early benefit assessment for MD (equal to medicinal products) 137h SGB V: Hospital that wants to use Device shall notify GBA Two weeks of Information gathering Three Months of assessment by GBA Publication of decision Accepted, rule for reimbursement (+ 3 months) Not accepted, but trial period (+ 6 months + trial) Not accpeted, barred from use September 2014 Seite 31

32 Legal Summary New Regulation for MD throughout Europe One Law for 28 Member States Clear decisions on applicability More clinical trials New Vigilance system New Benefit assessment September 2014 Seite 32

33 How to sell Mid-Size Company with ready-to-launch Medical Device would like to enlarge international presence without an own local structure/presence in envisaged market in about 3 12 months in order to: ü Foster growth strategy and commercial success of product ü Prove Design characteristics/handling in pilot study for external market ü Enlarge the awareness and reputation of the product and company ü Establish relationships with prescribers/users, intensify scientific and commercial opportunities and presence ü Increase (own) Commercial opportunities ( licence-out ) ü Grow awareness on own competence in business segment ( licence-in ) Partner with local Companies Engage Local Agency, which can offer/build a structure, (company, personnel, commercial and consulting service) to enter the market, and to establish own daughter company, when project has proven to be successful Establish own daughter company September 2014 Seite 33

34 Check-List to enter the external market ü Product is manufactured, ready to market, legally approved, logistics are clarified, price is defined ü Strategy internally aligned: ü Are the internal resources defined to monitor/support the external launch? ü Cooperation with Local Business Partner alternatively local Agency or building up own daughter company? ü New Market is in general commercially analysed: Which products are already available? Is the market saturated? Strength and position of competitors (incl. their pipeline?) Cultural /religious peculiarities assessed: e.g. no pork additives in religious markets in product, well chosen way of communication etc. Is there unmet medical need? Special niche for the own product? Where are the growth opportunities? Scientific atmosphere (early-/late adaptors) and attitudes of prescribers/decision makers Timing: 3-12 months September 2014 Seite 34

35 Pros & Cons Own Daughter Company Asset remains in own structure. Establishing own affiliate from beginning needs time, major investment and local knowledge (consultants?). By establishing own affiliate/daughter company the product remains your own asset and under your own control and strategy. The marketing and promotion is transparent to headquarter opposed to most licensees. Long term contracts for office (renting) and labour law risks with employees. Japanese Managing Director remains loyal September 2014 Seite 35

36 Local Agency Establish your affiliate and provides services and solutions at feasible investments and in short time with local experience and knowledge. Product remains your asset, shared risks, which are more with Agency. Bears the risk of long-term contracts and employees. All-inclusive-support (market entry & stay concept) as your affiliate, building up significant business relations, so you can hold all your assets under your control. Strong local relationships with science and commerce and network of optional business partners. Can later be transferred in an own, independent daughter company, if the product has proven to be successful. Easiest exit-strategy, if the product is not able to penetrate the market or for timely limited presence, pilot test, to check the product for market. September 2014 Seite 36

37 Big local Partners Time to establish business is shorter, as the resources are already in place and trained. Contracts are for longer periods, especially when the product is new. Experienced in Market and Stakeholders Have it s own strong standing with stakeholders which is good to establish new product. But it is difficult to separate from them as they will have all the sympathy of the community, in which he has introduced the product. Taking back the product might be delayed by partner in order to benefit from established commercial success as long as possible. Are less risk-takers and are only innovators for own products (to exploit full margin) Are selecting opportunities slower due to internal established procedures and have higher own cost because of their size. September 2014 Seite 37

38 Small local Partners Employees are younger and think "out of box. Have smaller projects than big local partners. They are used to change projects, which allows for broader views and different experiences for the best of the product. Are often cheaper as they do not have the big overhead costs to cover. Are dedicated to success, with high motivated team as each successful and satisfied client counts. September 2014 Seite 38

39 To Dos: Have a long-term strategy in the new country it is your investment into the future. Monitor your product's commercial and scientific development. Keep close contact and exchange experiences with your local partners / agency. Discuss and share Risk Management Considerations with local partners to minimize risk of regulatory problems. Encourage open communication and relationship between headquarter and local partner/agency in order to share knowledge. Consider Timing. Ask for your lawyer's commercial network. September 2014 Seite 39

40 Summary Market Entry It is a far-reaching decision to decide for an engagement in a foreign market. Only tailor-made partners should be chosen to fit your product and your strategy; names and reputations alone should not decide the issue. Open communication on your targets and sharing your vision gives you the best support from partners. Any partner shall be committed to improve patient's quality of life, be authentic towards stakeholders, decision makers, patient groups and be your worthy representative. People make it, people break it! Good Luck! September 2014 Seite 40

41 R E C H T S A N W Ä L T E See you at Medica, Hall 15, Booth H56 Kaistraße 2, D Düsseldorf Kurfürstendamm 195, D Berlin Tervurenlaan 40, B 1040 Brussels dierks@db-law.de