• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Small Innovators & Niche CROs

    Focus on Science

    Rapid and Data Rich Chromatographic Method Development

    Preparing Your Post Pandemic Talent Strategy

    How Modern Near-Infrared Came to Be
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Bristol Myers Squibb Expands at Cambridge Crossing

    Amgen Completes Five Prime Acquisition

    Sartorius Expands in the UK

    Obituary Notice: Russell “Russ” Haines

    Abenza Chooses North Carolina for New Biologics Manufacturing Site
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Abenza Chooses North Carolina for New Biologics Manufacturing Site

    Catalent Adds Cryogenic Capabilities at Philadelphia Facility

    Recro, Ensysce Expand Development and Manufacturing Partnership

    Metrics Names Stephanie Emory Associate Director of Pharma Development

    Albumedix Completes Commercial-Scale Mfg. Facility Expansion
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Obituary Notice: Russell “Russ” Haines

    Catalent Adds Cryogenic Capabilities at Philadelphia Facility

    Cryoport Acquires Critical Transport Solutions Australia

    PharmParts – This Makes Sense!

    Securing Your API Supply Chain: Three Keys to Success
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Bristol Myers Squibb Expands at Cambridge Crossing

    Amgen Completes Five Prime Acquisition

    Sartorius Expands in the UK

    Abenza Chooses North Carolina for New Biologics Manufacturing Site

    Arkema Recruits Dotmatics as its R&D Digitalization Partner
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Ensuring Pharma Manufacturing Quality

    What Will Change at FDA for 2021?

    RBQM Comes of Age: COVID as a Catalyst for Change

    Post-Pandemic Regulations

    Enteris BioPharma: Custom Solutions – From Bench to Market
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Reed-Lane

    Quotient Sciences

    Emergent BioSolutions

    Baxter BioPharma Solutions

    PCI Pharma Services
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Emergent BioSolutions

    Adare Pharma Solutions

    Quotient Sciences

    Baxter BioPharma Solutions

    Almac Group
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Features

    Regulatory Overhaul for Medical Devices

    Implications for the pharmaceutical industry.

    Regulatory Overhaul for Medical Devices
    Elizma Parry, Director, Global Clinical Practice, Maetrics 06.04.20
    Though regulatory collaboration between pharmaceutical organizations and drug delivery providers has been encouraged within the drug device combination product market for some time, pharmaceutical businesses marketing their products in the European Union (EU) are generally not well-versed in medical device regulation. However, as the combination product market grows and new technological innovations are introduced in device products, it is more important than ever before to ensure that both the drug and device components of combination products are given equal attention when it comes to product safety and efficacy. The EU Medical Device Regulation (EU MDR) published in 2017 addresses this very concern by clarifying and tightening regulatory scrutiny for device components. Meanwhile, the EU In Vitro Diagnostic Regulation (EU IVDR) has implications for pharmaceutical companies producing companion diagnostics. The Dates of Application for these new regulations are May 2021 and May 2022 respectively, meaning that pharmaceutical businesses must review their product portfolio without delay.

    Drug Device Combination Products: A need for regulatory clarity
    In the EU, combination products are regulated as medicinal products if the drug component is principal and not ancillary to the function of the device; or as medical devices when the drug has an integral but ancillary function. For products that fall into the first category, pharmaceutical businesses principally refer to the Medicinal Product Directive 2001/83/EC (MPD) to ensure compliance for the drug component, but this directive contains little guidance in relation to the device component. In addition, the EU MDR’s predecessor, the Medical Device Directive 93/42/EEC (MDD), did not elaborate on the requirements for device components within combination products regulated under the MPD. This lack of direction and of a link between the two directives created a regulatory gap where device components (combination product regulated as a medicine) were subject to a lesser degree of scrutiny than stand-alone medical device products.

    Article 117: Demonstrating conformity of device components
    A new point of reference for pharmaceutical companies is Article 117 of the EU MDR, which provides an amendment to Annex I of the Medicinal Product Directive. Article 117 outlines specific requirements for the device component, which businesses must now adhere to for their combination products to be deemed compliant. Specifically, where a product is governed by the MPD, the marketing authorization dossier submitted by pharmaceutical companies should include proof of conformity of the device component if it is available. To demonstrate proof of conformity, they must include results of the assessment of the conformity of the device component, in accordance with the relevant general safety and performance requirements of Annex I of the MDR, within their EU declaration of conformity. A second option is to submit the relevant certificate issued by a Notified Body allowing the manufacturer to affix a CE marking to the medical device. However, if the conformity assessment is missing, and requires the involvement of a Notified Body, the applicant must be able to provide an opinion issued by a Notified Body designated under MDR for the type of device in question. This opinion aims to demonstrate that a conformity assessment for the device component has been performed by a designated medical device Notified Body against the relevant requirements of the EU MDR. Essential elements of conformity include technical documentation which demonstrates the safety, performance and clinical benefit of the device, and ongoing post-market surveillance activities (inclusive of Post-Market Clinical Follow-up as needed) conducted in conjunction with risk management and clinical evaluation.

    Pharmaceutical Companies: Elements to prepare for
    Many medicinal product manufacturers were unaware of MDD requirements for their drug device combination products, and are therefore largely unfamiliar with device regulation. They must seek and build up expertise in this area to tackle increased scrutiny of medical device safety and performance. There are multiple elements to this: learning how to interpret the regulation, correctly developing compliance documentation, and liaising with Notified Bodies. Without prior experience and the right skills, tackling these may be challenging as medical device companies have already invested time and resources to implement compliance processes. The device industry is currently keeping watch for Notified Bodies to be designated under the EU MDR, as there have only been thirteen designations so far. Pharma companies must follow suit and ensure they are liaising with a Notified Body that is waiting for, or has already received a designation for devices that are subject to conformity assessment under the EU MDR. A final crucial point is that manufacturers can benefit from a variable extended transition period for those drug device combination products already holding a CE Mark under the current MDD 93/42/EEC until their certificate expiry date, but no later than May 26, 2024. Businesses that opt for this extension must be aware that they cannot make changes to the products unless they are re-certified according to EU MDR 2017/745, and so it is advisable not to delay in achieving compliance. 

    Companion Diagnostics: A new addition in the EU IVDR
    The EU IVDR includes a new product category for companion diagnostics, which will now be under greater regulatory scrutiny as a result. ‘Companion diagnostic’ refers to a device which is essential for the safe and effective use of a corresponding medicinal product, and can help to identify before and/or during treatment patients who are most likely to benefit from the medicinal product; or patients likely to be at increased risk of serious adverse reactions as a result of treatment with the medicinal product. Though the transition period for the EU IVDR is longer, there are only three Notified Bodies that have been designated for IVD devices to date, and there are fewer organisations awaiting designation in comparison with the EU MDR. In addition to Notified Body timelines, companies are dependent on national Competent Authorities (or the European Medicines Agency) for reviewing the associated medicinal product. This needs to be built into compliance planning, which should also take into consideration the stricter scrutiny that companion diagnostics will be under as Class C devices (the EU IVDR’s classification system terms Class A as the lowest risk and Class D as the highest). As with the EU MDR, clinical evidence supporting the intended purpose of the devices is essential for compliance submission. Manufacturers must follow a performance evaluation plan, demonstrating the following three elements: scientific validity; analytical performance; and clinical performance. Where there is a lack of data, new clinical utility studies may be necessary, further extending the compliance process timeline.

    No Grandfathering: Evaluating product portfolios
    Under the new medical device regulations, grandfathering is not permitted, meaning that every medical device needs a new CE mark. There are significant business implications of this as companies that do not meet the deadlines risk losing market access until their products are compliant. Pharmaceutical companies working with contract organisations for device components must safeguard their product portfolio by ensuring that these organizations are compliant. Reviewing device compliance, whether internally or at a partner organization, may seem daunting for companies that are doing so for the first time. For this reason, it is recommended that combination product pharmaceutical companies, as well as pharmaceutical companies that present medicinal substances with a Companion Diagnostic, develop expertise and implement compliance processes that will facilitate future assessments and help to ensure regulatory compliance in the long-term. 
    Related Searches
    • Drug Delivery

    Related Features

    • Drug Delivery | Solid Dosage/Creams/Ointments
      Trends in Solid Oral Dosage Delivery

      Trends in Solid Oral Dosage Delivery

      Capsule demand continues to rise due to this delivery system’s versatility.
      Anita Solanki, Milind Biyani and Jnanadeva Bhat, PhD , ACG Capsules 03.01.21

    • Drug Delivery | Parenterals
      Injectable Drug Delivery Trends

      Injectable Drug Delivery Trends

      How medication trends are driving the shift to patient-friendly drug delivery systems.
      Peter Soelkner, Managing Director, Vetter 03.01.21

    • Drug Delivery | Solid Dosage/Creams/Ointments
      Oral Solids:   Market & Technology Trends

      Oral Solids: Market & Technology Trends

      Oral solids remain the preferred route of drug delivery due to their cost-effectiveness, ease of manufacturing, and patient-friendly dose form options.
      Tim Wright, Editor, Contract Pharma 03.01.21


    • Drug Delivery | Solid Dosage/Creams/Ointments
      Medicated Chewing Gum: A Modern Oral Drug Delivery System

      Medicated Chewing Gum: A Modern Oral Drug Delivery System

      Development and manufacture of medicated chewing gum continues to gain momentum.
      Rukayat Adedeji, Contributing Writer 03.01.21

    • Drug Delivery
      Inhaled Drug Delivery Technology

      Inhaled Drug Delivery Technology

      The success of any new inhaled medicine relies in a large part on the correct combination of formulation and device technology being chosen for its delivery.
      Dr. Sandy Munro, Vice President – Pharmaceutical Development, Vectura 01.27.21

    • Drug Delivery | Injectables
      Self-Medication: Flexibility for Patients and Drug Manufacturers

      Self-Medication: Flexibility for Patients and Drug Manufacturers

      Bringing together self-medication with auto-injectors and sustainable secondary packaging.
      Matthias Heinrichs, Head of Product Management and Project Engineering, Syntegon Technology 11.17.20


    • Drug Delivery
      Wet Wipes Increased Prevalence in Drug Development

      Wet Wipes Increased Prevalence in Drug Development

      A number of factors including patient preference are driving the growth of wet wipes in pharma.
      John Waddell, Business Development Director – Pharma, PDI Contract Manufacturing 10.14.20

    • Drug Delivery
      Not Your Father’s Oral Thin Film

      Not Your Father’s Oral Thin Film

      A look at how oral film drug delivery is evolving.
      Rodolphe Obeid, Vice President of Operations, IntelGenx 06.04.20

    • Drug Delivery
      CEO Spotlight: Will Downie

      CEO Spotlight: Will Downie

      Vectura’s chief executive talks trends in the inhaled-drug market, and the company’s transition into a CDMO
      Tim Wright, Editor, Contract Pharma 04.01.20


    • Biologics, Proteins, Vaccines | Drug Delivery | Drug Development
      Knowledge Sharing: Biologics Development and Delivery

      Knowledge Sharing: Biologics Development and Delivery

      The increasing importance of sharing information to build awareness and better manage the complexities of drug development.
      Fran L. DeGrazio, Vice President of Scientific Affairs and Technical Services, West Pharmaceutical Services 09.16.19

    • Drug Delivery
      Nasal Drug Delivery

      Nasal Drug Delivery

      A look at best practices for testing nasal drug delivery devices
      Maria Smith, senior manager & Charles Shaw, scientific advisor, Renaissance Lakewood LLC 01.25.19

    • Drug Delivery | Drug Development
      Traveling Toward the Intersection of Drug Development and Delivery

      Traveling Toward the Intersection of Drug Development and Delivery

      Overcoming the challenges of delivering drugs to patients.
      Louise Righton, Global Marketing Operations Manager, 3M Drug Delivery Systems 06.12.18


    • Drug Delivery | Solid Dosage/Creams/Ointments
      FDCs on the Rise

      FDCs on the Rise

      Fixed-dose combination drugs continue to gain traction due to a multitude of benefits they offer, including speed to market a
      Betsy Louda, Associate Editor, Contract Pharma 03.09.18

    • Drug Delivery
      The Future of Inhaled Medications and Inhalation Technology

      The Future of Inhaled Medications and Inhalation Technology

      Formulations, devices and strategy through non-clinical development
      Simon Moore, Envigo 10.11.17

    • Drug Delivery
      Digital Drug Delivery: A Snapshot in Time

      Digital Drug Delivery: A Snapshot in Time

      Technology is transforming the future of drug delivery
      Sam Van Alstyne, 3M Drug Delivery Systems 10.11.17

    Trending
    • Thermo Fisher Acquires PPD For $17.4B
    • Ensuring Pharma Manufacturing Quality
    • Bristol Myers Squibb Expands At Cambridge Crossing
    • Abenza Chooses North Carolina For New Biologics Manufacturing Site
    • Amgen Completes Five Prime Acquisition
    Breaking News
    • Bristol Myers Squibb Expands at Cambridge Crossing
    • Amgen Completes Five Prime Acquisition
    • Sartorius Expands in the UK
    • Obituary Notice: Russell “Russ” Haines
    • Abenza Chooses North Carolina for New Biologics Manufacturing Site
    View Breaking News >
    CURRENT ISSUE

    April 2021

    • Small Innovators & Niche CROs
    • Focus on Science
    • Rapid and Data Rich Chromatographic Method Development
    • Preparing Your Post Pandemic Talent Strategy
    • How Modern Near-Infrared Came to Be
    • Securing Your API Supply Chain: Three Keys to Success
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    AstaReal Astaxanthin Ingredient Receives U.S. Patent Approval
    Study on Kemin’s DailyZz Botanical Blend Uncovers Sleep Quality, Next-Day Performance Benefits
    FDA’s Dr. Cara Welch Opening Speaker at the 9th AHPA Botanical Congress
    Coatings World

    Latest Breaking News From Coatings World

    Jebsen & Jessen, Innospec Sign Distribution Agreement
    IGL Coatings Announces Partnership in Finland
    Axalta Schedules 1Q 2021 Earnings Conference Call
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Iterative Scopes Announces IBD-Focused Scientific Advisory Board
    Vicarious Surgical, D8 Holdings Corp. Combine Operations in $1.1 Billion Deal
    FDA Grants De Novo Clearance to Medtronic’s GI Genius Model
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Bristol Myers Squibb Expands at Cambridge Crossing
    Amgen Completes Five Prime Acquisition
    Sartorius Expands in the UK
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Former L’Oréal Exec Joins Glossier
    Lancôme Reveals New Global Sustainability Program
    First-Ever Skincare Line Focuses on Iron To Prevent Aging
    Happi

    Latest Breaking News From Happi

    Fragrance Creators Association Celebrates P&G Executive
    Evonik Highlights Solutions for Malodor Reduction
    P&G Emphasizes Small Actions at Home To Be More Sustainable
    Ink World

    Latest Breaking News From Ink World

    Kumon North America Adds Speedmaster XL 106 from Heidelberg
    SE-DA Invests in Kornit Presto S
    Acrylic Resins Market Worth $21.9 Billion by 2025: MarketsandMarkets
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    TLMI reveals Eugene Singer Award winners at Virtual Spring Summit
    Monadnock Paper Mills joins SGP
    ACTEGA helps converter reach sustainability goals
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Albaad to Add Natural-Based Line in Israel
    First Quality to Discontinue Tampon Operations
    Jessup Installs New Era Coating and Laminating Line
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    BioMagnetic Sciences Names President and CEO
    Mainstay Medical Launches ReActiv8 in Australia
    Biogennix Rolls Out Agilon Strip Bone Graft
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Virtual ASMC 2021 Spotlights Advanced Semiconductor Manufacturing Excellence
    LG Display Cuts Down CO2-eq Emissions by 3 Million Tons in 2020
    European Commission's Innovation Radar Acknowledges 3 ARMOR Innovations

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login