Posts Tagged ISO 14971
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on July 31, 2013
Dr. Martine Dehlinger-Kremer, Global Vice President, Regulatory Affairs at Research Pharmaceutical Services, talked about Changing Medical Device Regulations in Europe, at www.bio2devicegroup.org event. Dr. Dhlinger-Kremer has over 27 years of experience in medical device regulatory affairs, progressively in higher leadership roles, including as VP of International and Global Regulatory Affairs as well as VP of Global Medical Affairs, in global CROs.
Definition and History of Medical Device Regulations in Europe
Medical devices include diverse group of products, from eye glasses to pacemakers. Dehlinger-Kremer began by sharing the history of regulations. Some European countries set up specific regulations for medical devices in 1976. By 1980s, there were specific pre-marketing approval requirements in most Western EU countries, but requirements were different, in different countries. In 1990s, there was a process to harmonize these requirements by introducing conformity assessment procedures, certain mandatory essential requirements, and by introducing of CE marking in 1995. Device Directive in 2007, added requirements for software and more stringent requirements for clinical data.
Current system of Medical Device Regulations
Currently, there are 3 directives (only one apply to one product), applicable in 33 participating countries. These are, Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD), and In Vitro Diagnostic Devices Directive (IVDD). Examples of medical devices include medical gloves, syringes, blood collection containers and it refers to any instrument, apparatus, appliance, software or material, whether used alone or in combination, for diagnostic or therapeutic purposes. Active implantable medical device refers to any device, totally or partially introduced, into the human body or by medical intervention, with the intention to be left there after the procedure and examples include pacemakers, cardiac defibrillators, bladder stimulators, cochlear implants and so on. Examples of in vitro diagnostic devices include reagents for blood group determination or for detecting infectious or hereditary diseases and so on and refer to reagent, reagent product, instrument or system, used in vitro, for the examination of specimens.
CA or Competent Authorities is the EU equivalent of USFDA. The CA has a final say in authorizing clinical trials, give a final classification decision, in case of a dispute, final authority over registration of manufacturers, and over safety measures. The CA appoints NB or Notified Body and NB is responsible for performance of audits, for issuing Certificates of Conformity, and for keeping CA informed. Current process to bring any medical device to market in EU, begins with the determination of classification and determination of conformity assessment. A technical file and design dossier needs to be set up, an authorized representative is appointed, clinical evaluation is performed, NB inspects the quality system when required, a declaration of conformity is prepared, and the device is registered and labeled. Post market surveillance should include, risk management system (ISO 14971), with proper reporting of all adverse events.
Challenges with the existing system
Several new changes are to be introduced do deal with various challenges that exist with the existing system. Some of the challenges of the current system include, Lack of harmonization and cooperation between MS especially regarding the designation and monitoring of NBs, Variation regarding quality and depth of the conformity assessment performed by NBs, Lack of transparency, including availability of data to public, traceability of devices; Access to external expertise; and Regulatory gaps or uncertainties with regard to certain products not covered by existing regulations, including cosmetic and nanotechnology products.
The Poly Implant Prothèses (PIP) Breast Implant Scandal that happened in 2012 was one of the major drivers for change. Rheinland (Germany) gave a quality certificate to the production process used by the company until March 2010. However, this didn’t apply to the type of silicone used. PIP used in the implants was of in-house manufactured, industrial-grade quality, instead of medical-grade silicone that is used in the majority of the implants. Almost 400,000 women globally and 100,000 across Europe, suffered from the unsafe implants. Now the EU is proposing updated regulations on medical devices in order to ensure these products are safe, and can be freely and fairly traded throughout the EU.
Proposed New Changes & Regulations
Proposal for changes was introduced in September, 2012 and is expected to be adopted by 2015. The aim of the new changes is to overcome current problems and gaps, strengthen patient safety, and introduce regulatory framework to be supportive of innovation. MDCG or Medical Device Coordinating Group will be the new group to oversee all EU countries and achieve harmonized interpretation and practice. There will be greater scrutiny of Class III devices. Member states will continue to appoint Notified Bodies but there will be strict criteria for the appointment and they will be made through joint assessments. Main stakeholders will now include, 1) CA or Competent Authorities that will designate and monitor NBs. 2) Notified Bodies that will be supported by MDCG and Commission and will conduct review process, maintain extended databases, conduct safety surveillance and safety measures, and assess manufacture compliance. They will be accredited by CA, the staff will require higher accreditation, and will be required to rotate. 3) Medical Device Coordinating Group or MDCG will comprise of experts who will be deeply involved in conformity assessment, particularly of high risk devices, and will advice the Commission. 4) The Commission will issue detailed guidance documents and will provide technical, scientific, and logistical support to other bodies. 5) EU Reference Laboratory, appointed by the Commission, will provide input on reference materials, on specific hazards and technologies and will contribute to continuing development of standards.
A new term, Economic Operator is introduced and refers to authorized representative, manufacturer, importer, and distributor. Another new term introduced is QP or Qualified Person and all manufacturers and/or authorized representatives will be required to have at least one QP who possesses expert knowledge in the field of medical devices and is a go to contact person, in case of problems. There will be some changes in classification of MD or medical devices. For instance, some previously classified Class IIB devices, like hip, shoulder, knee implants will be classified as Class III devices. IVD devices will still be classified in 4 classes, from A representing lowest risk to D representing highest risk. But there will be a change from list-based system to risk-rule based classification system, which will work similar to system for MDs.
Further changes are also introduced with respect to clinical trials, that include timelines, introduction of a Single Contact Point for CTA (clinical trial assessment), and a new concept of “sponsor” is introduced that is aligned with CTs on medicinal products. The sponsor will be required to notify the Member States concerned, within stipulated time, of possible adverse events. There will be simplified approval process for multinational trials. There is introduction of Post Market EU Portal for Reporting of serious post market incidents. For traceability, manufacturers/ ARs and importers will be required to register themselves and the devices
they place on the EU market in a central European database, supply chain will be tracked by Economic Operators, Unique Device Identification (UDI) will be assigned to the device to allow for traceability, and Implant Card will be provided to the patients. To increase transparency, manufacturers of class III, C & D devices, will be required to make a summary of safety and efficacy from the clinical data, publicly available. The Eudamed database will be expanded and will be made available to the public.
The proposed changes are expected to impact the timeline to bring medical devices to market in EU, as they will require additional trials to better document clinical outcome and some delay can happen in receiving the Certificate of Conformity from NB. However, they are expected to result in greater harmonization across Europe and enhance safety for the patients.
Active Implantable Medical Devices Directive (AIMDD), and In Vitro Diagnostic Devices Directive (IVDD), biotech, CA or Competent Authorities, CE mark, central European database, Changing Medical Device Regulations in Europe, Class III devices, clinical trial assessment, CTA, Device Directive, Dr. Martine Dehlinger-Kremer, Economic Operator, Economic Operators, Implant Card, ISO 14971, MDCG or Medical Device Coordinating Group, Medical Devices Directive (MDD), NB, Notified Body, Pharma & Medical Device News, Post Market EU Portal, QP, Qualified Person, Research Pharmaceutical Services, The Eudamed database, The Poly Implant Prothèses (PIP) Breast Implant, UDI, Unique Device Identification, USFDA, www.bio2devicegroup.org
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