Class I MDR Compliance

The European Commission has published a very comprehensive factsheet intended to support the legal manufacturers of Class I medical devices. Whilst the guidance is most welcome, and industry is humbly grateful, this publication now appears when the regulation goes into effect 28 Days Later (yes, reference to the zombie apocalypse film). Better late than never?

The EC factsheet provides clarity buried on page 3 item 2:

2. When do MDD Class I medical devices that remain as Class I under the MDR need to meet the requirements of the MDR?

Class I medical devices placed on the market under the MDD, that continue to be Class I under the MDR, will need to comply with MDR requirements as of 26 May 2021.

All Class I medical devices destined for the European market are required to guarantee compliance with all applicable requirements of MDR 2017/745 as of 26 May 2021. If a manufacturer of a Class I device (as per MDR classifications) already placed on the market was patiently waiting for this additional guidance prior to implementing internal processes, well it is a bit too late. European patients, hospitals, and healthcare workers should trust that astute regulatory teams have performed well within their organisations to facilitate these devices remaining available to provide foundational treatment and also to support life-enhancing therapies.

Since 2017, medical device manufacturer’s cross functional teams have been struggling to decipher the requirements, implement new processes, review/update documentation and source electronic tools, all essential to support continued regulatory compliance with MDR.

Compliance with the regulation for Class I medical devices will entail much more data exchange and collaboration between internal functions, external supply chain actors and regulatory authorities, with increasing volume and velocity. Device data, the company’s most valuable asset, needs special handling, care and security. Regulatory operations teams who have successfully manoeuvred through the myriad of requirements, should not be let down, so close to the finish line, by a lack of tools for data governance and management. Compliance with the MDR must be viewed by senior management as the opportunity to enhance capabilities of regulatory affairs which promotes a sustainable and scalable organisation.

Ensure your regulatory affairs operations have the support they need to keep Class I medical devices on the market.

KimYoung@instem.com

K Young

References

EC Factsheet for Class I Medical Devices: https://ec.europa.eu/health/sites/health/files/md_topics-interest/docs/md_mdcg_2021_factsheet-cl1_en.pdf

MedBoard LinkedIn Post: https://www.linkedin.com/posts/medboardco_eu-mdr-mdcg-class-i-devices-activity-6793228865935306752-rUwz

Photo by Brandi Redd on Unsplash

Importers – Strategic Partners

Importers – Strategic Partners

According to multiple regulations, importers of medical devices into the European marketing space must co-operate with the product manufacturers and authorised representatives to achieve an appropriate level of traceability of the devices they manage. Each economic operator connected in a medical device supply chain shall be able to check compliance of all the others involved.

Responsibilities

Importers are responsible for making sure that the devices they place on the market

  • bear CE marking,
  • are accompanied by any required information,
  • are labelled in accordance with the regulations,
  • have been assigned a UDI where applicable,
  • are registered in EUDAMED

Communications

  • If an importer considers a device is not compliant with the regulations, the importer shall not place the device on the market and the importer shall inform the manufacturer and the authorised representative of this action
  • The importer should also inform the authorities if they suspect that a device is counterfeit
  • The importer should inform the competent authority if the device poses a serious risk to public health

Labelling

Importers shall indicate on the device or its packaging, or in a document accompanying the device,

  • name, registered trade name or registered trademark,
  • registered place of business,
  • contact address

Vigilance

Importers have the responsibility to inform manufacturers and their authorised representatives in the event of complaints and escalate matters of non-compliance to the authorities

They should keep a catalogue of

  • complaints,
  • non-conforming devices,
  • recalls,
  • withdrawals from market

Importers are required to cooperate with authorities to provide device samples or grant access to the devices within their purview.

Device Handling

Importers should ensure that the storage and transport conditions do not jeopardise a device’s compliance according to the manufacturer’s instructions.

Medical Device Manufacturers

Manufacturers must be able to demonstrate control and monitoring of economic operators within the entire supply chain, which can be a regulatory compliance challenge during an audit.  This may be successfully accomplished by delineating all new responsibilities for distributors, importers, assemblers, and authorized representatives. Importers and manufacturers should pay particular attention to this issue when formulating contractual agreements.

Importers cannot execute their responsibilities unless the legal manufacturers enables them to do so by supplying the necessary documents and accurate information. Secure electronic database and data exchange solutions, on both sides, are required to ensure the correct data is transmitted to the correct entity in the correct timeframe and stored appropriately.

Manufacturers should realise championing their importers to comply with the myriad of regulations encourages the building of a strategic partnership which supports a stronger supply chain.

Medical device manufacturers must provide regulatory teams with the tools and resources to ensure smooth and compliant interactions with their linked economic operators as supply chain partners rather than third-party service providers.

KimYoung@instem.com

K Young

References:

EU Commission Blue Guide 2016 (updates currently in draft) https://ec.europa.eu/growth/content/%E2%80%98blue-guide%E2%80%99-implementation-eu-product-rules_en

EU Importer/Distributor Fact Sheet https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/importersdistributors_factsheet_en.pdf

Photo: Photo by Pat Whelen on Unsplash

Authorised Representatives: Effective Collaboration Required

Are you a global medical device organisation without a physical location in Europe? Of course, you are aware of the medical device regulation MDR 2017/745 mandatory requirement to appoint an EU Authorised Representative [(AR) or (EC REP)] to represent your company to the European competent authorities. Remember, this legal obligation is applicable for the marketing of all classes of medical devices, whether or not a notified body is required for CE marking. If you do not appoint a representative, you risk interruption to your supply chain.

Who is the AR?

An AR is any natural or legal entity established within the European Union who has received and accepted a written mandate from a manufacturer located outside the EU, to act on the manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s legal obligations under the Regulations for specific device families. (A manufacturer may have more than one authorised representative!)

What is the written mandate?

The mandate is the agreement document signed by the authorised representative and the manufacturer declaring the specific tasks to be performed by the AR on behalf of the manufacturer. The Authorised Representative will assume and share appreciably more risk and liability than currently assigned under the medical device directive.

What are an AR’s specific legal obligations which require effective collaboration?

As per MDR Article 11 (3), the agreed mandate shall require, and the manufacturer shall enable, the authorised representative to perform the following minimum tasks in relation to the devices that it embodies:

  • The AR must verify that the EU declaration of conformity (DoC) and technical documentation (TF) have been prepared and,
  • when applicable, that an appropriate conformity assessment procedure has been performed by the manufacturer;
  • The AR must keep available a copy of the TF, the EU DoC and, if applicable, maintain a copy of the relevant certificate, including any amendments and supplements, issued according to Article 56 (Certificates of Conformity), at the disposal of competent authorities (CA) for the period of 10 years (15 years for implantables) after the last device has been placed on the market

The manufacturer must enable access for the AR to the current DoC, TF and certificates of conformity for the device family as specified and all updates for 10+ (or 15+) years, including the ability to produce the current version as and when requested by the competent authorities. The AR must fulfil and perform these activities for all device classes, as applicable.

  • The AR must register with EUDAMED prior to a conformity assessment requiring notified body involvement and verify that the manufacturer has complied with the EUDAMED registration obligations for UDI for all device classes
  • The AR, when requested, must provide the CA with all the information and documentation necessary to demonstrate the conformity of a device, in the official language determined by the Member State

The mandate should specify who is responsible for obtaining and updating the translated conformity documentation and how the AR will be allowed access to the perform documentation assessments and verifications.

  • The AR is required to forward to the manufacturer any request by a competent authority for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device
  • The AR must cooperate with the competent authorities on any corrective or preventative action taken to eliminate or, mitigate the risks posed by the devices for which they are responsible

The mandate should include methods of communication and information exchange according to your internal procedures and timeliness of appropriate actions.

  • The AR must immediately inform the manufacturer about complaints from healthcare professionals, patients and end users about suspected incidents related to a device for which they have been designated

The AR and manufacturer will need secure processes and systems for monitoring, capturing, analysing and exchanging complaints data.

Suppose there is a need for a change of authorised representative for a device family. During the transition period, your organisation must communicate and exchange information with both the outgoing and the new authorised representative (MDR Article 12).

Are Authorised Representatives Audited?

The Competent Authority may audit an AR at any time, including unannounced, to determine if they understand their role, have direct access to the manufacturers documentation and have systems in place to ensure fulfilment of its role according to their mandate.

The AR will dictate and manage your relationship as legal manufacturer, including specified liabilities, with the competent authorities.

  1. Are you ready to begin communicating with and sharing your most valuable company asset, technical file documentation, as obligatory for the next 10 -15+ years for each device?
  2. Can your regulatory information management system effectively and securely comply with the required 3rd party data exchange?
  3. Have you upgraded your procedures to incorporate these additional communication and data exchange actions, including staff training?
  4. Do you have senior management and key stakeholder commitment for supporting these new collaborative commitment activities?

Regulatory professionals, please engage with your internal cross-functional teams, you are the experts in creating the appropriate MDR strategy. Do not let a lack of organisational understanding of the vital importance of the AR collaboration activities negatively impact MDR compliance and therefore successful management of your medical device supply chain.

Next time: Importers

KimYoung@instem.com

K Young

References:

Factsheet for ARs, importers and distributors: https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/importersdistributors_factsheet_en.pdf

MDR overview: https://ec.europa.eu/health/md_newregulations/getting_ready/authorised_representatives_importers_distributors_en

Actor registration module: https://ec.europa.eu/health/md_eudamed/actors_registration_en

Actor roles: https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/md_actor_roles_srn_en.pdf

Photo by Paweł Czerwiński on Unsplash

26 May 2021 and the Burden of Mandatory Collaboration

As an industry, we are all very much aware of that the requirement for compliance with European Medical Device Regulation 2017/745 is fast approaching. The looming 26 May 2021 deadline, coupled with the legislation governing medical device marketing across the UK due to Brexit, is fraught with new and amended challenges for the medical device industry.

Regulatory affairs teams across the globe are struggling to develop and implement the essential processes and procedures for administration of the commitments, as intended by the regulation, for their organisation’s multiple economic operators executing multiple functions, in what may be a very convoluted supply chain.

MDR articles 10, 11, 12, 13, 14, 15, 16, 17, 22, 23 and 25 though short in length, each describe an increased burden of responsibility for mandatory collaboration and legal liability amongst and between the members of the medical device supply chain. Each member in the chain has a role in supporting the compliance obligations of the rest of the “team”.

These economic operators and supply chain organisations are the downstream users of your most precious company asset – the confidential data, generated at great expense, to support the compliant marketing of your life enhancing medical device.

Who are the key players in the European medical device supply chain?

For example, how do you certify your distributors and importers will comply as follows:

Chapter III Article 25

Identification within the supply chain

1. Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices.

2. Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 10(8) (10 years or 15 years for implantables):

  • (a) any economic operator to whom they have directly supplied a device;
  • (b) any economic operator who has directly supplied them with a device;
  • (c) any health institution or healthcare professional to which they have directly supplied a device.

Optimistically, there are those regulatory professionals sitting in an enviable position with the capability to confidently describe and confirm readiness to comply with the MDR obligations related to supply chain traceability.

Let’s play 20 questions to see how you fare?

  1. Do you know exactly how you will manage transmission and exchange of your most valuable company asset?
  2. Are you in a perfect situation to keep your intellectual property from the badies?
  3. What checks are in place to ensure your data cannot be compromised by an external entity?
  4. Are your economic operators also working for your competitors?
  5. What are the security mechanisms for limiting or prohibiting downloading, for example, onto user desktops or printing data?
  6. Have you implemented an internal and external training programme for all parties (management and end users) to ensure procedures are followed to safeguard data integrity?
  7. Do you have the means to manage granular access control relating to read/write permissions, roles and responsibilities, including for example affiliate organisations?
  8. Will the staff at the economic operator have the ability to access your data from their home office?
  9. How will you manage data exchange for complaints and vigilance related activities?
  10. How will you guarantee each economic operator will have access to the current document version?
  11. What are your long term archival systems and disaster emergency plans for data transmissions?
  12. Can you identify a single point of contact for each entity + holiday cover?
  13. Does your organisation and each economic operator share a similar risk tolerance culture?
  14. Have they agreed to notify you when the competent authority conducts audits?
  15. Will you participate in competent authority audits for your economic operators?
  16. Will your organisation conduct unannounced audits of each establishment ?
  17. Who is responsible in your organisation to run and analyse data audit trails and reports?
  18. How will you assure consistency in data content and transmission across each economic operator?
  19. Are your proposed processes and procedures scalable as you add to your product portfolio and expand into new markets?
  20. Is your software solution a general-purpose tool or a tool specifically designed for data transfer functionality?

Were you able to successfully answer each question for ALL of the players in your European supply chain? Have you mapped your EU supply chain……

Whether your economic operators are internal or external, medical device legal manufacturers will require an investment in resources and a solution technology to meet the ever-increasing compliance needs of the regulatory team to stay ahead of the competition to ensure the smooth sailing for your devices into the hands of the end user.

Your supply chain, and thus revenue stream, is only as strong as the weakest link.

Next time, let’s discuss ways to strengthen those fragile collaboration links.

KimYoung@instem.com

K Young

References:

Regulation (EU) 2017/745

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Photo by Jackson Simmer on Unsplash

China – NMPA:396

Nǐ hǎo

Which photo best depicts your China regulatory strategy?

Last week I attended an excellent webinar sponsored by RAPS presented by Grace Fu Palma CEO of China Medical Devices (gpalma@chinameddevice.com). Grace provided the attendees with a very clear summary on the philosophies of the intended Chinese NMPA (ex-CFDA, ex-SFDA) programme for medical device and IVD legislation. Regulatory affairs team should always seek to obtain an understanding of the preamble and basis for health authority rationale which supports decision making thinking when determining your best approach to regulatory compliance.

The NMPA was very busy in 2020 and released 396 guidelines and notices. Such a surge surely exemplifies the impression that medical device and IVD regulation certainly looms large on their list of objectives.

The lists below provides a small sample for each category:

Industry Standards
Medical Electronic Equipment Part 2-56: Requirements for Basic Safety and Performance of Thermometers
Surgical Implants. Active Implantable Medical Devices Part 5: Circulation Support Devices
Ophthalmic Optics Intraocular Lens Part 8: Basic Requirements
YY/T 1752-2020 Basic Data Set of Medical Device Unique Identification Database
YY/T 1753-2020 Guidelines for Filling in the Unique Identification Database
Reagents (kits) for nucleic acid amplification detection – Implementation 01 Jan 2021
Artificial Intelligence Medical Device Quality Requirements and Evaluation Part 1: General requirements for datasets
Technical Review Guidelines
Guidelines for the Technical Review of Allowable Changes in In Vitro Diagnostic Reagents (Draft for Comments)
Technical Guideline on Raw Material Change Evaluation of a Non-active Device
Technical Review Guideline on Medical Device Software
Quality and Post Market Surveillance
Regulations on Surveillance and Sampling Inspection of Medical Device Quality, NMPA, 2020 #9
Specification on regular risk evaluation report of medical devices
Guidelines on Product Adverse Event Risk Assessment for Medical Device Registrants
Clinical Evaluation
Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation
Class III Medical Devices Requiring Clinical Trial Approval Catalogue (draft for comments)
Revised list of medical devices exempt from clinical trials (draft)

Many of these 396 new/updated/draft documents affect both external and domestic companies manufacturing for the Chinese market. For those corporations operating outside of China, it is vital for the global regulatory team, especially those responsible for global strategy, to ensure a thorough understanding of each document and not just rely on the translation.

Having lived and worked in many countries (including China), I truly understand the level of patience and perseverance required to successfully navigate multicultural segues. Regular communications, clear demarcation of responsibilities for project activities and real time regulatory data exchange processes, pillared in conjunction with cross cultural understanding (important whenever you are engaging with any local team) will effectively support regulatory compliance management.  

The brilliant NMPA presentation concluded with an emphasis on additional legal responsibilities for all players in the medical device marketing and supply chain, including an increase in penalties for non-compliance.

Regulatory Affairs teams: Do not rely on the lucky cat.

KimYoung@instem.com

K Young

References:

https://chinameddevice.com/

Photo by Malvestida Magazine on Unsplash

Photo by Paico Oficial on Unsplash

Internal Regulatory Intelligence

All regulatory affairs professionals are aware that keeping up to date with the global regulatory environment is an essential part of the day to day job description. There will be someone on your team, no matter how large or small, responsible for monitoring the thing that is the world wide web in order to extract data pertinent to your product portfolio. The information extracted from various external repositories is reviewed, assessed, collated, analysed, processed, interpreted, communicated and archived as regulatory intelligence.

Internal regulatory data and intelligence is an often forgotten, yet critical source of information. Every organisation’s electronic files provide a rich source of data for strategic registration planning and policy creation. Those regulatory team members searching for “intelligence” must be able to access and review historical interactions coupled with product and registration data such as:

  • Average time from submission of new application/registration or change request until health authority approvals
  • Previously received queries from health authorities and acceptance of company responses
  • Quality and quantity of interactions with specific health authority personnel as relationships are developed
  • Which products with the same or similar modification were managed successfully in order to support change impact assessments
  • Which implemented regulatory strategies in the targeted regions were not successful and required re-submission or withdrawal
  • Colleague experiences during execution of previous roles
  • Lessons learned following major regulatory project activities
  • All registration history for all products across all marketed regions

Without a centralised repository for product and registration data, regulatory affairs teams will struggle to quickly and efficiently obtain the strategically valuable key information unique to their organisations that is essential to provide thorough and complete regulatory guidance to business executives. Do not allow a flawed regulatory strategy, due to lack of accurate internal data, be accountable for missing key regulatory targets which impact your revenue stream and deprive patients of life enhancing products.

KimYoung@instem.com

K Young

Combination Products: MDR and Brexit

Hashtags#: To date, LinkedIn identifies 162 followers of #combinationproducts whereas the values for followers of #medicaldevice and #pharmaceuticals are 42 thousand and >1 million respectively. I find the figure for combination product followers disheartening especially when ascribing the low number as a direct proportion of individuals interested in this product category v number of possible LinkedIn regulatory affairs professionals engaged in combination product compliance. (Granted this interpretation is woefully unscientific – just presenting the observation for debate.)

The pharmaceutical and medical device industries are diligently striving to implement procedures, processes, justifications and documented evidence to support and manage compliance against Article 117 of the medical device regulation in time for the 26 May 2021 date of application. Article 117 of the medical device regulation, these two short paragraphs, strikes fear and uncertainty into the working lives of all regulatory professionals responsible for the life-cycle maintenance of any integral drug-device combination product (DDCs) destined for the European market or those markets reliant on CE marking for registration:

“Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of Regulation (EU) 2017/745 of the European Parliament and of the Council, a product is governed by this Directive, the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer’s EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.”

“If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation issued by a notified body designated in accordance with that Regulation for the type of device in question.”

The notified body, BSI Netherlands, has recently published notification to the regulatory world that they are the first to issue a Notified Body Opinion in relation to the requisites of Article 117. One adept manufacturer has already successfully manoeuvred through the process and obtained the golden chalice. There may be a glimmer of hope for those struggling regulatory operational teams, to hear the success story at a future virtual event.

The MDR also stipulates requirements for those medical devices containing medicinal substances, when the device has the primary mode of action, via classification rules 14 (medicine is integral and ancillary) and 21 (substance is intended to be introduced into the body).  

Be advised that due to (or in spite of) Brexit, the MHRA will continue to regulate DDC products and devices containing medicines, according to the EU MDD as transposed by the UK MDR 2002 (as amended). Of course, compliance is not free:

MHRA Drug-device combination products: fees

Device which incorporates a known medicinal substance from a source previously used in medicinal products or in medical devices where the MHRA has previously been consulted£4,136
Request by a notified body to the MHRA to supply an additional assessment report£818
Device which incorporates a known medicinal substance from a new source£9,640
Notified body request to the MHRA to supply an additional assessment report£2,228
Device incorporating a new active substance£42,296
Request by a notified body for the MHRA to supply an additional assessment report£10,501

As of 01 January 2021, all medical devices placed on the market or put into service in the UK must be registered with MHRA. This obligation for registration also includes medical devices, such as syringes or spoons, that are co-packaged (non-integral) with a medicinal product.

Be reminded that non-UK manufacturers must assign a UK Responsible Person (UKRP) to complete the registration process. The MHRA has allocated a grace period for the notification, based upon classification. This grace period only applies to those medical device products which previously did not need to be registered with the MHRA. If your new device to be placed on the UK market post-Brexit would have required registration with the MHRA prior to 30 December 2020, then the grace period does not apply and immediate registration is necessary.

Pharmaceutical regulatory affairs teams, please reach out to your medical device regulatory colleagues for support and collaboration. Allow them the opportunity to impart the requisite knowledge and expertise to overcome the combination product legislative challenges, for successful goal achievement – ensuring life-enhancing products remain in the marketplace for our patients.

K Young

KimYoung@instem.com

References:

MDR 2017_745

BSI Article 117 NBoP

MHRA Fees

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BLOG Intelligence

Instem provides advanced and best-in-class IT solutions & services to the global life sciences community to improve the productivity of their processes in the discovery and development of new drugs (human and veterinary), medical devices, invitro diagnostics, therapies and products. Instem delivers these software solutions and services across the entire lifecycle of product development, from concept, pre-clinical, clinical, registration to obsolescence.

This week, I would like to give a shout out to some of my blogger colleagues as Instem. In support of our mission to help clients bring their life enhancing products to market faster, every two weeks they offer experienced insight & solutions to common challenges and a platform for professional engagement.

In Silico Insider is written by subject matter expert, Glenn J. Myatt, the co-founder and head of Leadscope (An Instem company) with over 25 years’ experience in computational chemistry/toxicology. He holds a BSc in Computing from Oxford Brookes University, a MSc in Artificial Intelligence from Heriot-Watt University and a Ph.D. in Chemoinformatics from the University of Leeds. Glenn thrives on providing his loyal readership with an inside track when it comes to In Silico Safety Assessments. This blog is a must-go-to resource for scientists and professionals working in the Computational Toxicology field. https://insilicoinsider.blog/

Marc Ellison, Instem’s Director of SEND solutions, is a self-confessed SEND nerd who loves geeking out about everything to do with SEND. Marc is an active CDISC volunteer and member of the CDISC SEND extended leadership team. Be on the look-out every other Wednesday for Marc’s offering of sensible insights and subject matter expert opinions to help you navigate the challenges and opportunities that arise from the SEND standard. https://sensiblesend.blog/

The bi-weekly Pharma Whisper blog was created by Olaf Schoepke, Vice President Regulatory Solutions in order to share useful information about key industry regulations along with insights about how organizations are improving the efficiency of regulatory operations information management. https://pharmawhisper.blog/

Please be sure to pass the links for this brilliant information to your multi-disciplinary colleagues, remember regulatory success begins with effective collaboration.

KimYoung@instem.com

K Young

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UKCA for Medical Devices

I recently attended a brilliantly presented BSI webinar entitled: “UKCA for Medical devices and IVDs, are you ready?” which provided additional insight and confirmation of the UKCA conformity assessment process. I also propose a heartfelt thank you to Dr. Jayanth Katta for taking his time to provide the medical device and IVD industries with guidance.

Presentation highlights:

  1. Each legal manufacturer may assign only one UKRP in the UK
  2. EU CE marked products currently on the market in the UK may remain on the market (until 30 June 2023) however, these products must be registered with the MHRA according to the classification schedule
  3. Manufacturers continuing to market CE marked product must assign a UKRP, however they do not yet need to be identified on the labelling
  4. When BSI CE0086 certificates expire (or require amendments) they will automatically convert to UKCA certifications and be subjected to UKCA legislation

Conformity Assessment

  1. Note that conformity assessment models will differ between and amongst the UKABs
  2. BSI will start accepting UKCA applications during the last week of January but please note that they are still grappling with closing out actions relating to MDD deadlines
  3. For those manufacturers lucky enough to obtain CE2797 certification may be able to gain UKCA certification via an abridged review process
  4. For those manufacturers who obtain CE marking (directive or regulation) through a non-BSI EU NB, UKCA conformity assessment will follow the principles of EC certificate transfer

New Products

  1. BSI will endeavour to execute combined CE and UKCA assessments for medical devices whenever possible. This activity, is of course, subject to a number of caveats.
  2. The decision whether to submit and maintain combined or separate technical file documentation remains with the manufacturer
  3. Inconsistent classification should not impact a potential combined assessment

Due to the significant differences between the regulatory requirements for IVDD and IVDR, it is unlikely that a combined technical file and conformity assessment would be feasible.

During this unprecedented and challenging time, medical device and IVD regulatory professionals certainly have to keep a vast number of plates spinning in order to ensure their company’s products remain compliant for marketing. Those of you with the in decision making roles, please guarantee that your Reg Ops teams are equipped with the necessary tools and resources to support their revenue generating activities.

KimYoung@instem.com

K Young

References

https://www.bsigroup.com/en-GB/medical-devices/brexit-medical-devices/

Brexit for Medical Devices

As of 23.00 on 31st December 2020 the United Kingdom officially (and finally) withdrew as a member of the European Union (EU).

Firstly, a geography lesson: the sovereign nation commonly known as the United Kingdom consists of the island of Great Britain (England, Scotland and Wales) and the north east part of the island of Ireland (Northern Ireland).

The separation of the UK (GB + NI) from the EU has not only severed alignment with Europe but has also led to the partitioning of the application of legislation for medical and invitro diagnostic device registration, approval and marketing between Great Britain and Northern Ireland, per terms of the Northern Ireland Protocol.

Legislation Requirements

  • Products destined for the EU market must be MDR compliant as of 26 May 2021
  • Products destined for the NI market must be MDR compliant as of 26 May 2021
  • Products destined for the GB market will continue compliance with Medical Device Regulation 2002

Notified Bodies

  • UK approved body certification for NI is only valid for Northern Ireland (UKNI)
    • Note NI based manufacturers can continue to place CE and CE UKNI marked devices on the Great Britain market after 30 June 2023
  • UK approved body certification for GB is only valid for Great Britain (UKCA)
  • EU notified body certification for EU is valid for Northern Ireland (CE)

Authorised Representatives

  • UK Responsible Person is required for registration for non-UK based manufacturers to market in Great Britain
  • GB based manufacturers must appoint an EU or Northern Ireland-based Authorised Representative to market in Europe

CE Marking

  • EU will no longer accept CE certification from UK notified bodies from 01 January 2021
  • GB will accept EU CE marking until 30 June 2023 – however certification changes/updates during this period will necessitate a UKCA assessment

Labelling

  • UK CA mark mandatory on labelling for GB market from 01 July 2023
  • EU market will accept both CE and UK CA on labelling
  • CE + UKNI must appear on labelling for Northern Ireland market when certified by UK approved body
  • CE + UKNI labelling is not valid for EU

Registrations

  • MHRA will not have access to the EUDAMED database
  • All device products for GB market must be registered with the MHRA according to classification schedule (30 April, 31 August, 31 December 2021)
  • Where the manufacturer is in the UK or the Authorised Representative is in Northern Ireland, the following devices should be registered with the MHRA (no grace period)
    • Class I devices
    • Custom-made devices
    • General IVDs

These bullet points are just the highlights.

Please read the MHRA guidances and then read them again. When you think you may have thoroughly digested the information, discuss with your colleagues. Determination of how to maintain the lifecycle of your products for the EU, GB, and NI markets requires not only comprehensive knowledge of the regulations but also an intimate relationship with your entire portfolio. Implementation of a reliable electronic regulatory database is the essential tool to support compliance in this new environment, dependence on manual spreadsheets with their limitations, is significantly outmatched.

Comments respectfully requested

K Young

KimYoung@instem.com

References:

https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr

https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#contents

https://geology.com/world/british-isles.shtml

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