Navigating the maze of medical technology regulation: a solo voyage or a team effort?

  • Home
  • News and Papers
  • Navigating the maze of medical technology regulation: a solo voyage or a team effort?

Medical technology is a global business, generating annual revenues of over $400bn. The sector encompasses a broad range of technologies: from in-vitro diagnostics and diagnostic test equipment to medical devices that include toothbrushes, MRI scanners, orthopaedic joint replacements and drug delivery devices. It is also a sector characterized by high innovation: it attracts the largest number of applications to the European Patent Office of any technical field and more than the combined filings of pharmaceuticals and biotechnology.

However, all is not plain sailing. The publication in November 2018 of the Implant Files by the International Consortium of Investigative Journalists has caused reputational damage to the medical device industry, undermined patient confidence and prompted calls from many quarters for improved oversight and tighter control by regulatory authorities.

 

Given the public health impact of medical technology, it is no surprise that the industry is heavily regulated. A significant complicating factor is the diversity in global regulation faced by manufacturers. The US Food and Drug Administration has a dedicated unit overseeing medical device regulation, the Center for Devices and Radiological Health. In Europe, medical devices and companion diagnostics are regulated by national competent authorities with conformity assessments being conducted by approved notified bodies. However, certain medical device categories are assessed under European legislation by the European Medicines Agency.

Naturally, the two biggest global markets, the US and Europe, have different regulators that apply different rules. Together, these two markets represent around 70% of global medical device usage, the remaining countries introduce a plethora of different national requirements. With China set to become the second largest global medical technology market by 2020, the requirements of its National Medical Products Administration will undoubtedly become more prominent.

On top of regulatory requirements, the medical technology sector is also subject to international standards, such as EN ISO 13485: Medical devices – Quality management systems and EN ISO 14971 Risk management for medical devices. Supplementing these universal standards is a host of technical standards that apply to particular products and technologies.

Given the complexity of this environment, there have been some attempts to harmonize audit requirements, if not the rules themselves. Selected members of The International Medical Device Regulators Forum have introduced a single audit program (MDSAP) to assess the relevant requirements of participating authorities (Australia, Brazil, Canada, Japan and the US). A successful pilot was concluded in 2017 and a number of organizations have been authorized to conduct audits under the program.

Any company developing and manufacturing products in this sector faces a huge challenge: given the multitude of national and international regulations and standards, how should they comply with all necessary requirements, for all products, in all relevant markets? The answer, like the whole regulatory environment, is far from simple.

Each company designing processes for regulatory compliance will devote significant effort in deploying their own knowledge and experience. If multiple companies in the industry were to collaborate on designing effective and efficient regulatory compliance processes, then this broader knowledge base would deliver a more comprehensive output and the individual effort would be reduced. Moreover, the collective benefit would be enhanced for the participating companies while greater rewards could be delivered in terms of public health and for the multiple stakeholders in the industry: patients, health care professionals, health authorities and regulators.

Faced with the raft of current and emerging regulations and with possibly negative public perception, can the medical technology industry afford not to take the bold step of collaborating?

Contact address

BioPhorum
The Gridiron Building
One Pancras Square
London
N1C 4AG

Newsletter subscribe

You can unsubscribe at any time by clicking the link in the footer of our emails. For information about our privacy practices, please visit our website.



© 2019 Biophorum Operations Group · All Rights Reserved

Registered Address: 5 Westbrook Court · 2 Sharrow Vale Road · Sheffield · S11 8YZ

Company Number 06794795 · VAT Number GB298617544

Driving progress in Cell & Gene Therapy

Now with 19 member companies and 183 subject matter experts, the BioPhorum Cell & Gene Therapy (C>) Phorum has made great strides since its formation[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
Cell and Gene Therapy Phorum accelerates progress

The BioPhorum Cell & Gene Therapy Phorum has made significant progress since its creation in 2018 – from building networks and sharing knowledge to endorsing[...]

Read More
The BioPhorum and USP collaborative journey to new standards

BioPhorum and United States Pharmacopeia (USP) share a common direction – to accelerate biopharma innovation, quality and progress through collaboration.

Read More
Perfecting balanced scorecards for CDMOs

Established in March 2017, the Development Group’s Development Outsourcing effort aims to share and build guidance that will help companies make the best decisions and[...]

Read More
Formulation team drive for more value

Since its start in 2013, the Formulation Point Share has been busy. Its latest article, An inter-company perspective on biopharmaceutical drug product robustness studies, was[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Why leaders should go to where work is performed to learn about success, failure and risk
Read More
Hi-tech ambitions for Fill Finish

The Fill Finish Phorum has recently embarked on a series of exciting and ambitious initiatives, exploring new technologies and processes to enhance the efficiency and[...]

Read More
Companies poised to follow ARMM recommendations

The Advanced and Rapid Microbial Methods (ARMM) team set out a clear case for modernizing Environmental Monitoring (EM) in grade A settings: in summary bio-fluorescent[...]

Read More
How to achieve the ‘Goldilocks’ amount of environmental monitoring

Regulators require a risk-based approach to environmental monitoring (EM)… but they give no clear definition of what “risk-based” actually means. The aim of the Environmental[...]

Read More
The ‘how to’ guide to implementing Agile in GxP

The publication of the Guidance on the use of Agile in a GxP Environment document in 2017 was well received.It described how the use of[...]

Read More
How smart is your maintenance?

Faster. Cheaper. Smarter. All companies are under pressure to achieve more with less, not least with their maintenance programs. But while ‘faster’ and ‘cheaper’ maintenance[...]

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
Supply chain, forecasting and demand planning solutions gain momentum

The relationship between suppliers and manufacturers is one of the most crucial in biopharmaceutical manufacturing. This is especially the case when forecasting and supply planning.[...]

Read More
2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you to work on[...]

Read More
Changing mindsets with a modular approach

Historically, manufacturers have used a ‘waterfall’ approach when designing and building their production facilities, sequentially resolving and specifying all aspects up front and in detail[...]

Read More
Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the collaboration’s key new[...]

Read More
How do you bring technology roadmapping to life?

You use it to make change happen and that is exactly what the Phorum’s leaders did after the first edition of the Biomanufacturing Technology Roadmaps[...]

Read More
Slicing years off change implementation

As the first regulatory authority in Latin America to gain full membership of the International Council for Harmonization (ICH), the Brazilian Health Regulatory Agency (Anvisa)[...]

Read More
BioPhorum Regulatory Interaction: helping to open doors

To implement any change in the biopharmaceutical manufacturing industry it is important to engage with and collaborate with the regulators. Set up two years ago,[...]

Read More

IaaS Cloud webinar recording play back
Read More
New BPIT guidance to align cloud services to regulatory requirements
Read More
Data Integrity and Agile Webinars to support industry response to regulators
Read More
How to validate informatics in CPV programs

The BioPhorum Continued Process Verification (CPV) and Informatics team has published a paper to support a risk-based approach for the validation of informatics systems for[...]

Read More
Continued Process Verification delivering real saving in time and money

More than 50 per cent of biopharma products on the market now have Continued Process Verification (CPV) plans in place.  Thanks to the CPV white[...]

Read More
A roadmap for the implementation of continued process verification

This article provides a roadmap draws on the content of the CPV case study to provide a step-by-step guide in a more accessible form.

Read More
How smart is your maintenance?

Faster. Cheaper. Smarter. All companies are under pressure to achieve more with less, not least with their maintenance programs. But while ‘faster’ and ‘cheaper’ maintenance[...]

Read More
Digital plant maturity model webinar replay
Read More
Digital Plant Maturity Model workstream to host webinar
Read More
New guidance available on Forecasting and Demand Planning to streamline supply chain performance
Read More
Host cell proteins poster

This poster presented at the BEBPA Conference, San Francisco builds and consolidates the information currently available in the industry for assessing process risk from Host[...]

Read More
Host cell protein risk assessment, an industry approach

Host cell protein (HCP) constitutes a significant class of process-related impurities in biological drugs.

Read More
BEBPA risk assessment workshop
Read More
New toolkit to accelerate single-use design and specification

The single-use user requirements toolkit is now live and available for free download on the BioPhorum website  The toolkit streamlines the design and specification process[...]

Read More