Journal of Medical Device Regulation Issue Headlines - August 2017

Guest Editorial: Can the US FDA be brought ‘back to the future’?

The 21st Century Cures Act was signed into law on 16 December 2016. Putting aside whether enough funds will be dedicated to enacting Food and Drug Administration (FDA) policies, is this the legislation that will bring the FDA back to its proper role of adjudicating safety and effectiveness, that is, ‘back to the future’? In the view of this author, the answer is ‘no’, and this article explores the reasons why. More >>

Guest Editorial: The challenges in implementing the new European medical device and IVD Regulations

The Medical Devices Regulation and the In Vitro Diagnostics (IVD) Regulation ((EU) 2017/745 and (EU) 2017/746, respectively) came into force 20 days after their publication in the Official Journal on 5 May 2017. This marked the end of a very long road. It can be argued that the origins of the new legislation began with concerns in 2001/3 involving the recall of some total joint hip implants and the Trilucent breast implants which used a soya based filler. The subsequent European Commission consultation envisaged a major revision of the legislation, but in the event this was not carried forward and a more limited consolidation exercise was undertaken which resulted in Directive 2007/47/EU being agreed and enacted. The current Regulations have involved detailed discussions involving seven European Member State Presidencies and considerable debate. It was also necessary to invoke a special ‘trilogue’ procedure involving the Member States, the European Commission and the European Parliament to secure final agreement and adoption. The new legislation is a significant departure from the previous controls but the spirit of the ‘new approach’ is maintained, as is the evaluation role of the Notified Bodies. This article provides a brief overview of the new Regulations and looks at the UK’s situation once it leaves the EU. More >>

Focus: A Competent Authority perspective on the new European medical device and in vitro diagnostic legislation

On 5 May 2017, the European Commission published two new Regulations, one for medical devices and one for in vitro diagnostics (IVDs), to replace the current Directives which have been in place for over 25 years. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on IVDs (IVDR) will have staggered transition periods with some aspects, such as the Notified Body requirements, becoming legally binding after six months. The MDR will become fully applicable after three years and the IVDR fully applicable after five years. Until then the three Directives will remain in force. As the new legislation is in the form of Regulations rather than Directives, the European law is directly applicable at a national level without requiring transposition through specific national legislation. This should allow for greater legal certainty and help to prevent variation in the approach taken, or in the rules that are applied across Europe. This article by the Health Products Regulatory Authority (HPRA) in Ireland summarises the key areas of change in the legislation, highlighting aspects particularly relevant to manufacturers and to Notified Bodies. It also offers practical advice for implementation by manufacturers and Notified Bodies, and points out potential pitfalls for manufacturers. More >>

Focus: Economic Operators in the new European Regulations on medical devices and in vitro diagnostics

Amongst many other requirements, Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostics define the obligations, responsibilities, legal aspects, standards engagement and roles of all the Economic Operators (EOs) in the supply chain. An EO is described as a manufacturer, an Authorised Representative, an importer or a distributor. This concept is new compared to the Directives; previously the recipients of the provisions and responsibilities were the manufacturer and, for some aspects, his Authorised Representative. Now, importers and distributors also receive explicit mention and legal recognition of the obligations associated with their roles. This article examines the general obligations that apply to each of the EOs in the supply chain. More >>

Focus: Highlights of India’s 'Medical Devices Rules, 2017'

India published its first specific medical device regulations – the Medical Devices Rules, 2017 – on 31 January 2017, and these will come into force on 1 January 2018. At present, only a few medical devices in India are regulated as drugs under the Drugs and Cosmetics Act, 1940. As India is one of the largest medical device markets, it has needed for some time a robust system for the regulation of medical devices that takes into account the differences between medical devices and drugs. The Medical Device Rules, 2017 will be applicable to all the devices, in vitro diagnostics and other products covered under various notifications from the Government of India (i.e. currently regulated as drugs). However, the new Rules form the basis for the regulation of all therapeutic medical devices and in vitro diagnostics. Through the provision of clear timelines, fees and procedures, India is expected to emerge as a well organised and regulated medical device market. Also, the extensive similarity with harmonised international requirements and standards, the transparency of the system, and the use of online applications should ease the transition process for medical device and in vitro diagnostic manufacturers. This article summarises the main points of the new Rules. More >>

Country Overview: The medical device regulatory requirements in Ecuador

At present, only about 130 medical devices are manufactured in Ecuador, including cotton, gauze, vaginal speculums, sample collectors and hospital beds; therefore, about 99% of medical devices used in the country are imported. Ecuador has therefore needed to establish regulatory control mechanisms to ensure the quality of medical devices produced in the country as well as the quality of those that are imported. This article presents a brief outline of the relevant institutions, the legislation in force, and the processes for the control of medical devices in Ecuador. It also describes the challenges that the country and the Ecuadorian Association of Distributors and Importers of Medical Products (ASEDIM) are currently facing. More >>

European News

  • EU: New Regulations on medical devices and in vitro diagnostics finally published
  • EU: Products whose principal intended action (depending on PAC present in cranberry) is to prevent or treat cystitis, should not be medical devices
  • EU: New additions to REACH Authorisation List may affect medical device and IVD manufacturers
  • EU: Commission proposes new powers to request confidential information from companies and trade associations
  • Ireland: Guidance published on placing standalone software as a medical device on the market
  • Netherlands: Medical device legislation to be amended to help prevent corruption
  • Netherlands: UDI system to be introduced from July 2018, initially for implants
  • Norway: Norwegian Medicines Agency will become Competent Authority for medical devices in 2018
  • UK: MHRA Business Plan for 2017–2018 looks to regulation of devices post-Brexit and greater international collaboration

More >>

North American News

  • USA: Final list of Class II devices exempt from pre-market notification is published
  • USA: Validation data requirements for certain reusable medical devices
  • USA: Technical amendments align requirements for HDEs and IRBs for medical devices with 21st Century Cures Act
  • USA: Delayed implementation of UDI requirements for certain low-risk medical devices
  • USA: Comments sought on draft guidance concerning use of electronic records/signatures in clinical investigations under Part 11
  • USA: AAMI releases Technical Information Report on risk management of radio-frequency wireless coexistence for medical devices and systems

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Central & South American News

  • Argentina: Amended requirements for registration, modification and renewal of Class I/II devices, as well as applications to modify certain Class III/IV device data
  • Argentina: ANMAT Disposition No 7425/13 on GMP requirements for medical devices and IVDs has been amended
  • Brazil: Registration applications are now accepted in either electronic or paper format
  • Peru: Simplified registration requirements and shorter evaluation times for medical devices
  • Peru: Classification rules and Essential Principles of Safety and Performance proposed

More >>

Asia, Africa & Middle East News

  • Australia: 2017 fees and charges released by the Therapeutic Goods Administration
  • Australia: Legislative amendments made to standard conditions for ARTG inclusions
  • Australia: New Category C special access pathway for medical devices introduced
  • Australia: Consultation held on proposed strengthening of TGA powers to deal with compliance breaches
  • Australia: Use of overseas marketing approvals considered by the TGA
  • Australia: Guidance published on substantial changes to conformity assessment certificates and certificate transfers
  • China: Three significant medical device-related policy reforms proposed
  • China: New medical devices and IVD reagents proposed for exemption from in-China clinical investigations
  • China: CFDA to roll out inspections of medical device clinical investigation sites
  • China: CFDA sets out procedures for holding expert consultation meetings
  • China: Administrative measures for the supervision and management of networked medical devices are drafted
  • EAEU: List of voluntary compliance standards drafted for medical devices and IVDs
  • Egypt: Standard drafted for mounted spectacle lenses
  • Hong Kong: Proposed regulation for beauty/aesthetic medical devices, and voluntary registration plan for Class B and Class C IVDs
  • India: Date of manufacture and date of expiry must be printed on device labelling by 1 January 2018
  • India: New list of medical devices and IVDs and their classifications have been proposed
  • Japan: Minimum requirements for reprocessed SUDs to be established
  • Kazakhstan: Medical device nomenclature system and accompanying guidance approved by Ministry of Health
  • Kenya: Verification of conformity of imported medical devices re-introduced
  • Korea: Implementation of UDI expected to be phased in from 2018
  • Malaysia: Use of mercury-containing thermometers and sphygmomanometers to be banned
  • Malaysia: New guidance explains the requirements for export permits
  • Philippines: Powdered surgeons’ and patient examination gloves to be banned
  • Saudi Arabia: Updated guidance on conducting clinical investigations of medical devices
  • Singapore: New Pre-Market Consultation Scheme and Priority Review Scheme unveiled
  • Singapore: Guidance drafted on the application of the Singapore Standard for Good Distribution Practice for Medical Devices
  • Taiwan: ‘Medical Devices Act’ drafted to separate medical device and drug legislation
  • Turkey: Regulation drafted on registration, traceability and follow-up of medical devices

More >>

Global Interest News

  • CEN, CENELEC and EEC formalise their cooperation

More >>