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.
Each legal manufacturer may assign only one UKRP in the UK
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
Manufacturers continuing to market CE marked product must assign a UKRP, however they do not yet need to be identified on the labelling
When BSI CE0086 certificates expire (or require amendments) they will automatically convert to UKCA certifications and be subjected to UKCA legislation
Note that conformity assessment models will differ between and amongst the UKABs
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
For those manufacturers lucky enough to obtain CE2797 certification may be able to gain UKCA certification via an abridged review process
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
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.
The decision whether to submit and maintain combined or separate technical file documentation remains with the manufacturer
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.
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.
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
UK approved body certification for NI is only valid for Northern Ireland (UKNI)
NoteNI 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)
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
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
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
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
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.
Devices without a medical purpose are excluded from the scope of the Medical Device and Active Implantable Medical Device Directives, however a group of such products are now regulated in the Medical Device Regulation 2017/745 due for application on 26 May 2021. The rationale behind their inclusion is based upon potential unreasonable risks these device types may impart upon use. The legislation applies to these products regardless of whether the point of use is at home by the end consumer or in a healthcare professional setting.
List of product groups WITHOUT an intended medical purpose now within scope of MDR:
Products under scope of Annex XVI do not need to comply with the MDR until the common specifications (CS) for the respective product types have been adopted and published by the Commission. This publication is envisaged as being not later than 26 May 2021. Adherence to the CS will be mandatory for manufacturers 6 months from date of issue or from 26 May 2021 (whichever is earlier). Note, according to the MDR implementation rolling plan, these CS were due Q4 2020, the Commission may not meet this deadline as they remain in the planning stage. Until the CS are published, individual Member States’ national qualification of products described in Annex XVI will remain in force.
Common specifications (CS) refer to technical and/or clinical requirements (other than a standard), that provide a means of complying with the legal obligations applicable to the device. It is anticipated that the CS for Annex XVI products will take into account existing harmonised standards which apply to analogous medical devices. These new CS will at a minimum, incorporate requirements for risk management and may even include clinical evaluation for assessing safety.
Overall execution of compliance for these devices must take into account the state of the art, and in particular, existing standards for comparable devices with a medical purpose, based on similar technology. Even if not yet required to comply with the MDR, Annex XVI product manufacturers need to prepare NOW for compliance:
assign risk classification
comply with Common Specifications
have an authorised representative in the EU, if the manufacturer is outside the EU
maintain technical documentation including declaration of conformity;
affix CE marking
assign a unique device identifier (UDI) and submit data to EUDAMED
submit Economic Operator information to Eudamed
appoint a person responsible for regulatory compliance
maintain a quality management system
post-market surveillance and vigilance requirements, including field safety corrective actions and reporting serious incidents to the competent authority
monitor compliance for organisations in the supply chain e.g. distributors
maintain insurance against potential product liability.
Additionally, there are mandatory requirements for manufacturers to provide consumers with certain information, an example – implant cards for those receiving implantable devices, such as dermal fillers.
Do not exhale a sigh of relief if your non-medical device product does not currently fall under the regulation. The EC will continue to monitor for any risks identified and failure of safe performance of this product class, thus possibly (probably) adding additional device descriptions under the scope of MDR Annex XVI.
And, do not forget about United Kingdom and Switzerland……
For the manufacturers of these devices, it will no longer be a case of “sell them and forget them”.
If you are a manufacturer of an Annex XVI device destined for or already marketed in Europe and are struggling to cope, please get in touch.
Regulatory Relief To Support Economic Recovery; Request for Information (RFI)
AGENCY: Office of the Secretary, Department of Health and Human Services.
ACTION: Request for information.
75720 Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices
The United States Department of Health and Human Services (HHS) is considering making permanent and/or keeping as temporary the regulatory standards and amendments promulgated in response to the COVID–19 crisis, issued in order to improve early access to care and reduce costs.
The HHS, via executive presidential order, has an obligation to continue to remove regulatory barriers that could be challenging to the American economic recovery. In compliance with this obligation, the Department is reviewing certain regulatory practices.
HHS intends that some of these regulatory changes and flexibilities will remain temporary, some permanent, or permanent with modification. Through the mechanism of this RFI, HHS is seeking to gather feedback and relevant evidence from the key stakeholders to support their decision making process—healthcare providers, advocacy groups; industry trade groups; health insurance issuers, research and policy experts; industry and professional associations; patients and patient advocacy groups; Medicare and Medicaid beneficiaries, and any other interested members of the public.
Here is your opportunity to help shape, amend and/or request discontinuation of the regulatory changes implemented by the FDA via the Emergency Use Authorisation (EUA).
Based upon commenters evidence, the HHS will consider phasing out or discontinuing regulatory changes that show the negative impacts outweighing any benefit of the regulatory change on a temporary basis or would have negative impacts outweighing the benefits if continued beyond the current crisis.
Attachment A of the federal register notice provides a list (note it is declared not exhaustive) of the regulatory changes for which the HHS is requesting feedback. Items 22 through 74, relate to the FDA and includes issues relating to animal medicines, decontamination procedures, ventilators, hand sanitisers and PPE equipment.
The key questions presented for comments:
Of the regulatory changes that have been made in response to the crisis, please identify which changes;
a. Have been beneficial to healthcare providers, human services systems, or to the patients and clients, and under what circumstances;
b. Have been detrimental to healthcare providers, human services systems, or to the patients and clients, and under what circumstances;
c. Have been beneficial to healthcare providers, human services systems, or to the patients and clients on a temporary basis, but would be detrimental if continued following the current crisis
Of the regulatory changes that have been implemented in response to the pandemic, please identify which changes:
a. Should be maintained only for the duration of the pandemic
b. Should be maintained permanently
c. Should be extended for a period of time, however not made permanent
d. Should be modified but maintained after the end of the pandemic, and thus made permanent with modifications
e. Should be discontinued immediately
If you are an interested party and/or a key stakeholder, to be assured that your comments are considered, you must submit your evidence electronically to http://www.regulations.gov no later 11:59 p.m. on 28 December 2020.
It must be further noted that all comments received before the close of the comment period will be available for viewing by the public.
Please see the link below to view the RFI document and the relevant Attachment A.
Some of you may remember the Taiwan Food and Drug Administration (TFDA) Unique Device Identification (UDI) Guidance published on 30 October 2015 which kick started the voluntary UDI pilot programme.
On 05 November 2020, the TFDA published a new draft guidance document for public consultation. The guidance document, “Requirements for the Single Identification Code to be Published on the Labels of Medical Devices”, outlines new requirements for the creation and application of UDI information for the medical devices and in vitro diagnostics under TFDA regulation. As the draft document is open to public consultation, concerned parties now have until 04 Jan 2021 to provide feedback via the channels listed below:
Webpage of the “Health and Welfare Law Search System” or “Public Policy Network Participation Platform-Zhongkai Talking”
Food and Drug Administration, Ministry of Health and Welfare
No. 161-2 , Kunyang Street , Nangang District, Taipei City
The draft guideline pronounces the following requirements:
The single package or device body of Class II and Class III medical devices should be marked with a unique device identifier (UDI); if the single package or the device is too small, the UDI should appear on the smallest saleable unit.
The owner or registrant of the medical device license shall upload the product corresponding information (see below Table I) of the identification code to the TFDA medical device identification system database
The following medical devices are exempt from marking UDI:
Special devices for export only
Medical devices and in vitro diagnostic medical equipment that are non-implantable medical equipment components for single use only and are not used separately and sold.
The draft also states that the coding principles will generally follow the International Medical Device Regulators Forum (IMDRF) recommendations.
Similar to other regional UDI database requirements, the owner or registrant of the medical device license shall register on the UDID platform before the device enters the market. If a device change results in an updated DI, the owner or registrant of the medical device license, must upload the new DI and corresponding information into the UDID prior to the new product entering circulation.
Mandatory implementation for Class III implantables to begin 01 June 2021.
Table I: Information to be provided to TFDA UDID
Timelines and data exchange requirements to meet the ever evolving global UDI obligations must be captured in your regulatory assessment and regulatory strategy communications.
For those regulatory professionals who thought the UDI quagmire was sorted, have you thought about the unique identification requirements as legislated by Peoples Republic of China via the NMPA? On 10 August 2020 the NMPA launched Unique Device Identification (UDI) Database on its website.
From 01 January 2021 (43 days from blog posting date)
the first group of 64 Class III medical devices shall have unique identifiers
Please be aware, even though only 50 data attributes are necessary for submission to the China UDID database, less than US FDA and significantly less than under MDR, 30% of these attributes are UNIQUE for China UDI. Thus, yet another set of regulatory data to capture and maintain.
It really took a bit of trolling through the internet to finally find a complete list (in English) of the 64 devices assigned for the first phase of UDI implementation (It would appear that access to English translations of the 64 product names are carefully shrouded in unobtainability ):
The Chinese medical device and in vitro diagnostic market is growing substantially. When conceiving and articulating your global regulatory strategy, the requirements for global UDI demand to be at the forefront for accurate decision making. Regulatory professionals, ensure that senior management understands your operational workflow constraints and prerequisites for capturing, maintaining, accessing, amending and transmitting global UDI data necessary for maintaining compliance and therefore marketability. Compliance translates into revenue and patient satisfaction.
As always, please refer to the original NMPA data sources for confirmation of requirements as translations may be inaccurate.
If your organisation does not have a physical location in Europe, you are required, by the medical device regulation MDR 2017/745, to appoint an EU Authorised Representative (AR) or (EC REP) to represent your company to the European authorities. You must retain an AR for as long as you market your medical device in Europe. This legal obligation is effective 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, your products destined for the EU market may be stopped at the border.
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 particular 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. The MDR stipulates a list of minimum requirements for mandate declaration and agreement.
What are an AR’s specific legal obligations according to the regulation?
As per 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 and technical documentation have been prepared and, when applicable, that an appropriate conformity assessment procedure has been performed by the manufacturer;
This task requires the AR is allowed access to the manufacturers DoC andTFs for the device family as specified and has the applicable expertise to determine compliance
The AR must keep available a copy of the technical documentation, 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 devices specified and all updates for up to 15 years, including the ability to produce the current version when requested by the CA.
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
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 mandate should include methods of communication and timeliness of appropriate actions
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
As the AR will be held jointly and separately liable for defective medical devices, one can assume that an AR will be monitoring a manufacturers compliance very thoroughly and insistent on complete cooperation with CAs
The AR must immediately inform the manufacturer about complaints from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated
The AR and manufacturer will need processes and systems for monitoring, capturing, analysing and exchanging complaints data
The AR is obligated to terminate the mandate if the manufacturer acts contrary to its legal obligations as per the Regulation.
The change of authorised representative requires an agreement that defines the arrangements between the manufacturer and both the outgoing and the new authorised representative (Article 12). Changing an AR may be costly as the AR details are included in the labelling.
Be mindful that Article 11(4) also specifies the tasks that a manufacturer cannot delegate via the mandate agreement to their AR. This includes requirements related to the device design, QMS system, clinical evaluation, writing technical documentation and labelling; as these are the individual responsibilities of the manufacturer.
Does having an Authorised Representative impact labelling? The manufacturer must include the name and address of the AR on the product label, outer packaging and/or Instructions for Use. This information of the AR should be shown next to the official logo.
Are Authorised Representatives Audited?
The Competent Authority can 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.
What about Brexit?
Following the UK’s departure from the European Union, anyone based outside the United Kingdom (EU or non-EU) will require a UK-based responsible person to act on behalf of the manufacturer to initiate or continue selling in the UK. This includes registering with the MHRA before the device is placed on the UK market. Furthermore, UK-based companies will require an EU-based AR, as illustrated above, to initiate or continue selling in the EU.
Non-European Medical Device Manufacturers:
Your choice for authorised representative is critical for initiating and/or continuing the successful marketing of your devices within the European community.
Your AR will dictate and manage your relationship with the competent authorities.
Your appointed AR must be willing and capable to share and administer legal obligations under the Regulation to support your products.
Are you ready to begin communicating with and sharing your technical documentation as obligatory for the next 10 -15 years?
Within each regional UDI system (Unique Device Identification), manufacturers are legally obliged to identify and register their medical devices. It all instances, this is not just about receiving a single UDI code, and recording what was submitted and to which authority, but requires the collection, management and submission of perhaps a hundred odd data elements in addition to the UDI code. A fact often overlooked and underappreciated.
Meeting these complicated and variable needs for each health authority’s “unique” device identification requirement in a global environment is an arduous task. UDI data compliance adds an additional layer of complexity to an already resource stretched team. Managing the regulatory data across regions, languages, timezones and facilities without a robust and efficient process is not sustainable. Non-compliance is not an option.
As always, please free to contact me with blog comments or suggestions for future post topics. I appreciate all feedback 🙂
The topics for discussion serve as a stark reminder that our medical device industry remains inadequately prepared for application of the MDR and IVDR regulations. For example:
Path to Compliance: Industry EU MDR
EUDAMED update: Status and Future Timelines of Implementation of the EUDAMED Database
Strategies to Manage your Distributor Regulatory Risk
Meeting the New PMS Reporting Requirements of MDR & IVDR with Future-Proof Systems
Granted, I understand that 2020 has been a challenging, arduous and hellacious year but it appears, based upon some of the audience questions, that there are organisations who have not yet begun considering how they will implement actions to ensure compliance.
If an organisation is still asking basic questions today, at 233 days (5352 hours) until application of MDR, when will they actually be prepared??
I would really like someone to explain to me, just what is the problem with preparedness??
Is it a lack of understanding or awareness of the requirements?
Who lacks the understanding?
How do we get them to understand?
Is it a lack of resources?
How to approve the funding allocations?
Do they think application will be delayed again, therefore have even more time?
Wishing for another crisis? I hope not.
This lack of readiness does not bode well for the future of the European medical device market from 2021. Well at least in the immediate future.
Will those companies who are “ready” dominate the EU market?
Will the smaller SMEs disappear altogether?
What will happen to product availability?
I know that I have asked a lot of questions. If anyone has the answers, I would love to hear from you.
European Regulatory requirements1 DISTRIBUTORS of medical devices or in vitro diagnostic devices have specific obligations to fulfil under Article 14 of both the MDR and IVDR.2,3 Distributors will have to verify whether:
the device has the (CE) mark and an EU Declaration of Conformity has been issued;
the importer’s name is affixed on each device or is in the attached documentation (where applicable);
the device bears a unique device identifier assigned by the manufacturer (where applicable);
the device is labelled properly and has instructions for use (IFUs) in an official language of the country in which it will be marketed
In addition, distributors are responsible for:2,3
ensuring storage and transportation of devices under appropriate conditions as defined by the manufacturer; and
notifying the manufacturer and competent authorities when they suspect a device has been falsified or presents a serious risk to patient health
These are the facts.
A question for medical device and IVD distributors: How will you ensure compliance?
As the regulatory operations teams working for medical device and IVD manufacturers are struggling to manage the myriad of internal MDR/IVDR data requirements,
Who in your organisation is managing and supporting all of your economic operators to ensure no disruption to your supply chain and revenue stream?
Are you assuming your distributors have got it covered as it is their responsibility?
Can you even link your economic operators to a specific device or even device family?
How will you exchange the necessary data between yourselves and your disparate distribution chain?
For those of you who cannot confidently answer these questions, I suggest giving me a call.