BSI Medical Device Blog 2017

Medical Devices and Cyber Security

The Internet of Medical Devices (IoMT) is growing rapidly, so rapidly that it is being touted as the future of healthcare. The IoMT is an interconnected infrastructure of medical devices, software, monitoring devices, and data convergence systems. The IoMT offers a variety of benefits, from remote monitoring to live time data feeds, to easing pressures on under-resourced hospitals and public health budgets. As technology pushes digital health in new directions, each new iteration brings both potential and challenges.

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BS EN ISO 13485:2016 harmonized under the Directives for medical devices

European Commission publishes additions to the list of standards cited in the Official Journal

European standards that are cited in the Official Journal of the European Union (OJ), called harmonized standards, provide a presumption of conformity for the regulatory requirements for which they are cited. There have been long delays in getting new and revised standards added to the list of standards harmonized for the Medical Device Directive (MDD), Active Implantable Medical Device Directive (AIMDD) and In Vitro Diagnostic Medical Devices Directive (IVDD).

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Have you documented your strategy for regulatory compliance?

New requirement of the regulations for devices is also a key element of planning your transition

A new requirement for a manufacturer of medical devices and In Vitro Diagnostics (IVDs) is to have a strategy for regulatory compliance. This is listed in Article 10 of the Medical Devices Regulation (MDR) and IVD Regulation (IVDR), where the general obligations of manufacturers are detailed.

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ISO publishes handbook of quality management system guidance for ISO 13485:2016

New publication provides additional support for transition to the new edition of the key QMS standard for medical devices

The International Standards organization (ISO) has published an ISO Handbook of guidance on ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes. It is titled ISO 13485:2016 – Medical devices – A practical guide. ISO 13485:2016 was adopted in Europe as EN ISO 13485:2016.

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Are you aware of Common Specifications and their role in the medical devices regulations?

Common Specifications introduced in the European regulatory scheme for medical devices and IVDs

A previous blog discussed the use of standards to support regulation in Europe and in the USA. The Medical Devices Regulation (MDR) introduces a new concept alongside harmonized standards, called Common Specifications (CS). These are currently included in the In Vitro Diagnostic Medical Devices (IVD) Directive where they were called Common Technical Specifications and were for Annex II List A products. They are now renamed and have been incorporated in Article 9 of both the MDR and the In Vitro Diagnostics Regulation (IVDR).

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What are the differences between Market Surveillance, Post-market Surveillance and Vigilance?

Regulations for medical devices have distinct terms for oversight of devices on the market

One area that has been changed substantially in the Medical Devices Regulations (MDR) and In Vitro Diagnostic Medical Devices Regulations (IVDR) is the oversight by manufacturers and competent authorities of devices on the market. The Regulations use the terms market surveillance, post-market surveillance (PMS) and vigilance. The differences between these terms are not always understood.

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Using voluntary, consensus standards to support medical devices regulations

Developments on both sides of the Atlantic in the use of standards

With its work plan for implementing The 21st Century Cures Act, the US FDA has introduced changes in its programme to recognise standards in support of medical devices regulation. Manufacturers can submit a declaration of conformity to a recognised standard to facilitate the review process to clear their devices. The FDA has recognised more than 1,200 standards developed nationally within the USA or internationally by ISO and IEC.

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Have you identified your person responsible for regulatory compliance?

Medical device and IVD regulations have specific responsibilities for this new role at manufacturers and Authorised Representatives

Article 15 of both the Medical Device Regulations and the In Vitro Medical Device Regulations have significant new requirements for appointing a ‘person responsible for regulatory compliance’. Manufacturers and Authorised Representatives (AR) for both medical devices and IVDs have to identify at least one such person. This person responsible for regulatory compliance has to meet minimum requirements for qualification and experience.

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Changes in the Medical Devices Regulation affect drug delivery devices

The Medical Devices Regulation introduces significant changes in approval process under the Medicinal Products Directive

Article 117 of the Medical Devices Regulation (MDR) (Regulation (EU) 2017/745) amends the Directive on medicinal products for human use (MPD) (Directive 2001/83/EC). This will significantly affect pharmaceutical manufacturers supplying drug delivery devices in combination with their medicinal products (such as pre-filled syringes).

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For how long will you need certificates of conformity to the Directives for medical devices?

Knowing the dates of validity for certificates of conformity is critical in transition planning

An earlier blog post referred to the continued validity of certificates issued under existing Directives after the end of the transition periods for the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The transition provisions in Article 120 of the MDR and Article 110 of the IVDR need careful consideration.

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Own Brand Labelling renamed as virtual manufacturing

UK MHRA issues revised guidance for Manufacturers and Notified Bodies

MHRA has recently issued revised guidance dated March 2017. Own Brand Labeller (OBL) was the term used to describe an organization that places their own label/brand name and name and address on a device that they haven’t designed, don’t manufacture, and is already CE marked and on the market in the name of another company. In this recent guidance, MHRA indicates that it is replacing the term ‘Own Brand Labelling’ with ‘virtual manufacturing’.

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Medical device regulations clear final barrier to adoption

European Parliament gives positive votes on the EU regulations for medical devices and IVDs

The long-awaited EU Medical Devices Regulation (MDR) and In Vitro Diagnostic medical devices Regulation (IVDR) received a positive vote in the European Parliament on 5^th April. Medical device manufacturers, Notified Bodies and Competent Authorities have been holding their breath in case of a last-minute hitch. But in the end, both Regulations had a substantial majority for adoption.

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