EU Regulatory Requirements Update, the latest news and developments Hans-Heiner Junker TÜV SÜD Product Service GmbH October 2013 Folie 1
Content Two groups of Notified Bodies Designation process with European involvement More qualification requirements for auditors, experts and certification personnel Reprocessing not possible, but Qualified person Implant Card Folie 2
2 Different Groups of Notified Bodies Group 1: Notified Body for class I, II a and II b Group 2: Notified Body for high-risk devices Group 1 will be designated by national authorities Supervision by national authorities, plus other national authorities, plus European agency Group 2 will be designated by EMA Supervision by national authorities, plus other national authorities, plus European agency, plus EMA Group 2 will include the Notified Bodies called :Special Notified Bodies Folie 3
No PMA, but Article 43a Involvement of the Special notified bodies in the conformity assessment procedures of high-risk devices Only Special notified bodies (SNB) shall be entitled to conduct conformity assessments for the following devices: implantable devices, devices referred to in Article 1(4), devices referred to in Article 1(5) and point 5.3. of Annex VII (Rule 11), devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or are rendered non-viable, or Class III devices. Folie 4
High-Risk Devices devices referred to in Article 1(4) states: Where a device, when placed on the market or used in accordance with the manufacturer's instructions, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in Article 1(2) of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in Article 1(10) of that Directive, with action ancillary to that of the device, that device shall be assessed and authorised in accordance with this Regulation. Folie 5
High-Risk Devices devices referred to in Article 1(5) and point 5.3. of Annex VII (Rule 11) Article 1(5) states: Where a device is intended to administer a medicinal product as defined in Article 1(2) of Directive 2001/83/EC, that device shall be governed by this Regulation, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product. Rule 11 states: All active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body are in class IIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and if the mode of application in which case they are in class II b. Folie 6
Electronic system on "Special notified bodies The Commission, in collaboration with the Agency, shall establish and regularly update an electronic registration system for: the registration of applications and granted authorisations to perform conformity assessments as Special notified bodies under this Section and to collate and process information on the name of the Special notified bodies; the exchange of information with national authorities; and for the publication of assessment reports; The information collated and processed in the electronic system and which relates to Special notified bodies shall be accessible to the public. Folie 7
Article 44: Mechanism for scrutiny of certain conformity assessments Deleted, but... Article 44 a (new):assessment procedure for the conformity assessments of certain high-risk devices Applications from manufacturer must be forwarded to EMA and Commission by the SNB Draft instructions for use Draft summary of safety and clinical performance report Estimated date of completion Commission will forward this information to ACMD (21 sub-groups) Folie 8
Article 44 a (new): Within 20 days of receipt of the information referred to in paragraph 1, the ACMD may decide... The members of the relevant sub-group of the ACMD shall decide... The ACMD shall issue an opinion on the summary of the preliminary conformity assessment at the latest 60 days after its submission... The ACMD shall inform the Commission, the notified body and the manufacturer of its opinion within 5 days of its adoption... More involvement = more time = more time to market More involvement = more resources = more money Folie 9
ACMD Article 78 a (new): Assessment Committee for Medical Devices The ACMD shall be composed of sub-groups, in accordance with the medical fields referred to in paragraph 3... Each sub-group of the ACMD shall be composed of: One expert from member states Where available: three representatives of patients' organisations... One representative of the European Medicines Agency (EMA) All for a three-year term which may be renewed Folie 10
Following sub-groups will be established: 1. Anaesthesiology 2. Blood grouping or tissue typing 3. Blood transfusion and transplantation 4. Cardiology 5. Communicable diseases 6. Dentistry 7. Dermatology 8. Ear / Nose / Throat (ENT) 9. Endocrinology 10. Gastroenterology 11. General/Plastic surgery 12. Medical genetics 13. Nephrology / Urology 14. Neurology 15. Obstetrics/Gynaecology 16. Oncology 17. Ophthalmology 18. Orthopaedics 19. Physical medicine 20. Pulmonology / Pneumology 21. Radiology Folie 11
Designation Process for Group 1... a joint assessment team made up of at least three experts chosen from a list of experts who are qualified in the assessment of conformity assessment bodies and free of conflicts of interest with the applicant conformity assessment body. The list shall be drawn up by the Commission in cooperation with the MDCG. At least one of these experts shall be a representative of the Commission, and at least one other shall come from a Member State other than the one in which the applicant conformity assessment body is established. The Commission representative shall lead the joint assessment team....the relevant national authority shall base its decision on the designation of the notified body on the recommendation by the MDCG. In case where its decision differs from the MDCG recommendation, the relevant national authority shall provide the MDCG in writing with all the necessary justification for its decision... Folie 12
Classification In order to ensure consistent classification across all Member States, particularly with regards to borderline cases, it should be the responsibility of the Commission, having consulted the MDCG and the MDAC, to decide on a case-by-case basis whether or not a product or groups of products fall within the scope of this Regulation. Member States should also have the possibility to request the Commission to take a decision on the appropriate regulatory status of a product, or category or group of products. MDCG defined in Article 78 Folie 13
Article 78a (new): Medical Device Advisory Committee The Commission shall establish a multidisciplinary Medical Device Advisory Committee (MDAC) composed of experts and representatives of the relevant stakeholders in order to provide support, advice and expertise to the MDCG, the Commission and Member States on technical, scientific, social and economic aspects of regulating medical devices and in vitro diagnostic medical devices, such as in the field of medical technology, borderline cases involving medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products, as well as further aspects of the implementation of this Regulation. Folie 14
Groups Involved EMA = European Medicines Agency MDCG = Medical Device Coordination Group MDAC = Medical Device Advisory Committee ACMD = Assessment Committee for Medical Devices Notified Bodies Special Notified Bodies Joint audits by national designating authorities designating authorities from other member states Representative of the European Commission Independent body for the review of manufacturer's PMCF evaluation report Folie 15
Reprocessing of single use devices Article 15a General principles on single-use devices and reprocessing of reusable devices All medical devices shall be treated as reusable devices unless: they are listed as single-use devices unsuitable for reprocessing referred to in Article 15 b, or they are labelled as 'single-use' by the manufacturer, in accordance with Article 15 c. Folie 16
Article 15 b List of single-use devices unsuitable for reprocessing In accordance with Article 15 a (1) first indent, the Commission, by means of delegated acts, shall establish and regularly update, including by adding or removing, a list of medical devices which are unsuitable for reprocessing. These devices shall be labelled as single-use, owing in particular to their intended use in or on the human body and the body parts they will be in contact with, the conditions of their use, their intended purpose and the material of which they are composed of. Folie 17
Article 15 c Labelling of medical devices as "single-use" Where a device is labelled as "single-use", in accordance with Article 15 a (1), second indent, it is the responsibility of the manufacturer to provide a justification based on sufficient scientific evidence, such as tests results or reference to relevant standards, studies and recent scientific publications in the field of reprocessing, that the device cannot be reprocessed safely. Folie 18
Article 15 d Requalification of a single-use device as reusable Any natural or legal person who wishes to reprocess a device labelled as "single-use" included in the special list of single-use devices, in accordance with Article 15 b, or in accordance with Article 15 c, and who has evidence that such a device could be safely reprocessed shall inform the Commission of the intention to do so. The requisite evidence shall be submitted by the natural or legal person who wishes to reprocess a device to one of the EU reference laboratories, as referred to in Article 81. Folie 19
Article 15 e Reprocessing of medical devices labelled as reusable Any natural or legal person, including health institutions as specified in Article 4(4), who reprocesses a device labelled as "reusable" shall: comply with the EU standards referred to in paragraph 2; ensure that, in case of a single-use device re-qualified as reusable in accordance with the procedure referred to in Article 15 (d), the reusable device is reprocessed in accordance with the opinion of the EU reference laboratory, as referred to in Article 15 (d), paragraph 2; ensure that the reusable device is not reprocessed beyond the maximum number of times specified for that device; be held responsible for its reprocessing activities. Folie 20
Definition Old definition of single-use device has been deleted instead 'single-use device' means a device that is intended to be used on an individual patient during a single procedure and which has been tested and demonstrated to be impossible to reuse. "Reusable device" means a device that is intended to be used on multiple patients or during multiple procedures. Folie 21
Qualified Person Draft: Manufacturers shall have available within their organisation at least one qualified person who possesses expert knowledge in the field of medical devices Compromise: Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices Expertise for specific devices? Folie 22
Implant Card This card shall contain the following: the information allowing identification of the device, including the Unique Device Identification 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 description of potential adverse effects any information about the expected lifetime of the device and any necessary follow-up principal characteristics of the device, including the materials used Member States may introduce national provisions requiring that the implant card includes also information on post-operative follow-up care measures The following implants shall be exempted from this obligation: sutures, staples, dentals implants, screws and plates. Folie 23
Transparency Eudamed shall include the following as integral parts: 1.the electronic system on UDI referred to in Article 24; 2.the electronic system on registration of devices and economic operators referred to in Article 25; 3.the electronic system on information on certificates referred to in Article 45(4); 4.the electronic system on clinical investigations referred to in Article 53, 5.the electronic system on vigilance referred to in Article 62; 6.the electronic system on market surveillance referred to in Article 68. 7.the electronic system on registration of subsidiaries and subcontracting referred to in Article 29a. Folie 24
Still included Annex I: Essential Requirements on the Safety and Performance Annex II: Technical Documentation Annex XV: Devices as medical devices Transition period: 3 years New application of organizations that would like to become a Notified Body Folie 25
What Jungle? Commission Council European Parliament Folie 26
Estimated Output New MDR Trilogy Folie 27
Thanks for your patience Folie 28