Dear Customers and Partners
Corona has changed everything, but between the COVID-19 measures and regulatory fast tracks, there are certain changes unrelated to COVID-19 that one needs to be aware of. You can find a selection of these changes in this newsletter.
In April all eyes were on how quickly the European Commission proposed, passed, and published the delay to the Medical Device Regulation (MDR) in the Official Journal. Thanks to the publication on 24 April 2020, it is now official that the new date of full application of the MDR is 26 May 2021 and that the current Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) will continue to apply until 26 May 2021.
This gives the European Commission more time to designate additional notified bodies. As of today, there are 14 notified bodies designated under the MDR and three under the IVDR. The extra time also allows time to create further guidance documents and structures. Recently, the MDCG has issued various guidance documents to support the MDR implementation. The postponement gives manufacturers more time to ensure MDR compliance, and especially to ramp up the collection of clinical data, including PMCF.
The FDA has been busy releasing Emergency Use Authorizations (EUAs), having expedited regulatory pathways that healthcare providers need most such as ventilators, face masks and PPE, and test kits. It also announced the postponement of domestic and foreign routine surveillance inspections, and extended the response due dates for pending marketing authorizations.
ISS Knowledge Management Team
- EU - MDR one-year delay official after amending regulation is published in EU Official Journal
- EU - MDCG guidance documents
- EU - Team NB issues position paper on documentation requirements for combination products
- Germany - DiGAV entered into force after publication in Bundesgesetzblatt
- EU - Medtech Europe issues position paper on the use of state-of-the-art standards in the absence of harmonised standards
- EU - Fast track approval – conformity assessment and market surveillance within the context of COVID-19
- Brazil - Changes regulation on change notifications for medical devices
- Canada - Changes policy for annual renewal fees and updates application forms
- USA - FDA informs about extension of response due dates for pending marketing authorizations
- USA - FDA guidance on nonbinding feedback after FDA inspections
- USA - Updated guidance on ecopy program for medical device submissions
- USA - Guidance on third party review program finalized
- USA - Guidance on appeal processes of PMA review decisions published
- USA - FDA issues cybersecurity warning for certain devices using a wireless communication technology known as Bluetooth Low Energy
- EAEU - New draft on registration procedure
- Kazachstan - Slight ease in medical device examination
- Russia - Draft to align safety and effectiveness evaluation with EAEU and on SaMD
- Russia - New rules for medical devices containing alcohol
- Australia - Another consultation on scope pf regulated software products
- China - UDI database publicly available
- China - Timeline extended for renewal applications due to COVID-19
- China - NMPA plans to do more inspections
- China - New adverse event monitoring guidelines
- China - Updates various standards
- Hong Kong - Accepts device approvals from South Korea
- Indonesia - New Medical Device Division domain and withdrawal of devices containing mercury
- Philippines - Implementation of new rules delayed due to COVID-19
- Singapore - Updated guidance on change notifications
- Thailand - New labelling requirements for products containing alcohol postponed
- AHWP - Changes name to Global Harmonization Working Party (GHWP)
- IMDRF - Published various important guidances
The European Commission adopted a proposal on 3 April 2020 to postpone the application date of the Medical Devices Regulation (MDR) by one year to 26 May 2021. The European Parliament voted in favour of the Commission’s proposal on 17 April, which was published in the Official Journal on 24 April 2020.
The European Commission informed about the impact of the delay on the Eudamed database. The new plan now is to make the module on actor registration available first, deploying it by March 2021 at the latest. The module on UDI/device registration and the module on certificates and notified bodies will be made available by May 2021. The remaining modules will become available afterwards as soon as they are functional.
TEAM NB published a statement on the new EU Regulation 2020/561 amending the medical device regulation (EU) 2017/745. Welcoming the amendment, TEAM NB recommends to all manufacturers and stakeholders in the medical device sector to pursue their original plans for the transitioning from the Directives MDD/AIMDD to the Regulation 2017/745.
Team-NB statement on MDR date of application postponement (Team NB, 28.04.2020).
MedTech Europe welcomes the postponement of the DoA of the MDR. Medtech Europe urges for similar action the IVDR and regrets that the EU institutions and national authorities have decided not to establish the immediate possibility for EU-wide derogations to be granted to critically needed IVDs, as has now been done for certain medical devices.
MedTech Europe welcomes the amendment of the Medical Devices Regulation and urges similar action for the IVD Regulation (Medtech Europe, 22.04.2020).
Swiss Medtech informed its Members about the consequences of the delay, which include that Swiss medical devices can be placed on the market within the EU single market up until 26 May 2021 without the need to fulfill non-member country requirements.
Information to the Swiss medical technology industry (Swiss Medtech, 17.04.2020).
The European Commission is now publishing guidance documents and other documents related to the implementation of the EU’s Medical Device Regulation (MDR) at a high rate, including the most recent update of the manufacturer incident report form.
In the second week of March, the long-awaited guidance document on the interpretation of the words “significant change” was endorsed by the MDCG. The guidance provides decision-making criteria and flowcharts to determine whether a change is significant.
The following guidance documents on clinical evaluation and clinical investigations were published:
- MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software (17.03.2020).
- MDCG 2020-5 Clinical Evaluation - Equivalence. A guide for manufacturers and notified bodies (24.04.2020).
- MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies (24.04.2020).
- MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies (24.04.2020).
- MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies (24.04.2020).
The following guidance documents were recently updated:
- MDCG 2019-8 v2 - Guidance document - Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (16.03.2020).
- MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR) (17.03.2020).
- MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI (17.03.2020).
TEAM-NB has issued a position paper on documentation requirements for drug/device combination products, focusing on products that fall under the scope of Article 117 of the EU’s Medical Device Regulation (MDR).
Drug/Device Combinations: New Position Paper Explains Notified Body Responsibilities (Medtech Insight, 09.04.2020 -$).
On 21 April 2020, the Digitale Gesundheitsanwendungen-Verordnung (DiGAV) came into force in Germany, one day after publication in the Bundesgesetzblatt. It is accompanied by an extensive Guidance issued by the Medicines and Medical Devices Agency (BfArM).
Digitale-Gesundheitsanwendungen-Verordnung (DiGAV) (Bundesministerium für Gesundheit).
Medtech Europe issues position paper on the use of state-of-the-art standards in the absence of harmonised standards
Medtech Europe issued a position paper to explore alternative solutions to consider in the absence of harmonized standards (and the Standardisation Request, which is the prerequisite for harmonization) under the MDR.
The Commission has published Recommendation (EU) 2020/403, which states that to address the shortage of personal protective equipment (PPE) necessary in the context of the COVID-19 outbreak, market surveillance authorities may (even though the conformity assessment procedures, including the affixing of CE marking, have not been fully finalized according to the harmonized rules) authorize the provision of these products on the EU market for a limited period and while the necessary procedures are being carried out.
The Resoultion No. 340/2020 published in March 2020 and the IN 61/2020 (lists types of changes and their classification) came into effect on 01 April 2020. Changes are now classified in three categories.
- Major change (approval required)
- Medium change (notification required)
- Minor change (self-documentation)
Effective date of the new regulation: 01 April 2020
RDC 340/2020 (ANVISA, 11.03.2020).
IN 61/2020 (ANVISA, 11.03.2020).
As per 01 April 2020 revised fees and policies came into effect which applies to Class II, III and IV medical devices holding a valid licence. Up today fees were paid per active license and gross revenue. This system is changed with the new policy and fees will be charged by establishment annual gross revenue. Deadline remains 01 November each year.
As of 01 April 2020, Health Canada will
- No longer credit fees based on a product’s gross revenue but by establishment size and annual gross revenue.
- Grant fee mitigations for small businesses (<100 employees or annual gross revenue between CAD $30’000 and $5 million, regardless of the geographic location). Section 2.3 Mitigation measures in the guidance document.
- Reduce the fee (by 25%) in case they do not reach the performance standard of 20 days to update the Medical Device Licence Listing Database after receiving the Annual Notification Package. Section 2.4 Missed Performance Standards in the guidance document.
From 01 April 2021 onwards fees will increase annually. Fees for the next year will be published in fall on HC Fees website. Fees for different medical device applications from 2020-2024 are visible here in table format.
Small Business Status
The small business status is granted after formal registration at HC via their https://dmdsba%2Dapemim.hc%2Dsc.gc.ca/app/">Secure Web Portal Account. If you do not yet have such an account follow the steps on the HC website closely to get the activation code and all setup properly:
- Small business fee reduction measures
- Before you apply for small business status
- How to apply for small business status
- After you apply for small business status
Evidence to apply for a small business status (might be asked from HC at any time):
- Records that identify the number of persons employed for the previous fiscal year
- Financial statements
- Tax returns
- Corporate and/or management organization charts
- Other official documents issued or certified by a business registration authority
To reflect this change various forms and guidances were were updated:
- Class II Medical Device Licence Amendment Application Form (HC, 15.04.2020).
- Application for a New Medical Device Licence for a Private Label Medical Device (HC, 07.04.2020).
- Medical Devices Licence Amendment Fax-Back Form – Guidance for Guidance for Changes to the Manufacturer's Name and / or Address of Existing Device Licences Only (HC, 23.04.2020).
- Medical Devices Licence Amendment Fax-back Form - Guidance For Non-significant Additions/deletions (HC, 15.04.2020).
- Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device (HC, 09.04.2020).
In a letter to the industry, the FDA explains the steps (CDRH) that prioritize work that advances the nation’s response during this national emergency, such as hosting teleconferences rather than in-person meetings with industry scheduled through 31 May 2020.
For marketing applications on hold as of 16 March 2020, where the response due date is on or before June 30, 2020, CDRH has further extended response due dates by 90 days for Premarket Notifications (510(k)s), Premarket Approval (PMA) applications (original and supplements), Humanitarian Device Exemption (HDE) applications (original and supplements) and De Novo classification requests. CDRH intends to extend this due date automatically; no extension requests are necessary to be submitted.
Updated Letter to Industry on COVID-19 (FDA, 04.04.2020).
A new guidance has been released concerning non-binding feedback after certain FDA inspections of device establishments. The guidance explains how a request for non-binding feedback from the FDA regarding actions the company proposes to address certain kinds of inspectional observations that have been documented.
Nonbinding Feedback After Certain FDA Inspections of Device Establishments (FDA, April 2020).
FDA finalizes medical device post-inspection feedback guidance (RAPS, 22.04.2020).
This guidance describes how the FDA is implementing the eCopy Program under section 745A(b) of the FD&C Act. The inclusion of an eCopy is expected to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version.
eCopy Program for Medical Device Submissions (FDA, 27.04.2020).
The FDA finalized the guidance on its 510(k) third party review program (3P510k) detailing how it will determine whether different types of devices are eligible for third party review and explaining how third party review organizations are recognized under the program.
510(k) Third Party Review Program (FDA, March 2020).
The FDA issued a guidance document providing the Center for Devices and Radiological Health (CDRH
interpretation of crucial provisions outlined in section 517A of FD&C Act. Section 517A of the FD&C Act contains provisions for documenting and reviewing certain decisions in the premarket review of device submissions. The document outlines the provisions about requests for appeals of significant decisions under as well as for the timeframes and procedures of regulatory decisions and actions taken by CDRH under 21 CFR 800.75.
(FDA, March 2020).
FDA issues cybersecurity warning for certain devices using a wireless communication technology known as Bluetooth Low Energy
The FDA informs about the SweynTooth family of cybersecurity vulnerabilities, which may introduce risks for certain medical devices. Security researchers have identified 12 vulnerabilities, named “SweynTooth,” associated with a wireless communication technology known as Bluetooth Low Energy (BLE). BLE allows two devices to “pair” and exchange information to perform their intended functions while preserving battery life.
Russia and Eurasia
Aim of this draft is to reduce cost and time to register products in EAEU member states.
Draft Amendment (EEC, 20.02.2020).
The Amendment Order No 736 published in March 2020 introduces that testing is slightly simplified and no longer required for products already registered in EU, USA or Japan as well as in case of renewals. Overall examination procedure and timelines remain the same.
Amendment to Order No 736 on “Approval of the Rules for Examination of Medicines and Medical Products” (Ministry of Health, 21.03.2020).
This draft is another step in the long ongoing project to harmonize regulations in EAEU. The rules published now for comments shall align the safety and effectiveness evaluation of medical devices with EAEU. After review of the draft manufacturers ready for MDR/IVDR compliance might not face huge additional requirements.
Draft amendment to the rules for registration and examination of safety, quality and effectiveness of medical devices (Department of Technical Regulation, 18.02.2020).
The draft (announced in November 2019) is published for comments and aligned with IMDRF guidances.
Announcement 297/20 (Roszdravnadzor, 13.02.2020).
New Order No 7975 on medical devices containing alcohol requires notification of medical devices concerned until July 2020 with documentation as required in Resolution No. 774.
Aim is to setup a list of medical devices containing alcohol not regulated under the general alcohol regulations in Russia (Federal Law 117).
Order No. 7975 (Roszdravnadzor, 23.10.2019).
Resolution No. 774 (Russian Federation, 15.06.2019).
Asia & Oceania
TGA started another consultation to exempt or exclude specific software-based medical devices from the regulatory framework. Concerned are low-risk medical devices or software regulated under another framework. The consultation includes i.a. clinical decision support software or consumer software depending on the intended use but only software that meets the definition of a medical device.
Consultation: Scope of regulated software-based products (TGA, 03.2020).
The NMPA UDI database is open for public and manufacturers since March 2020. Implementation is planned to start with Class III products from 01 October 2020 on.
Directlink: NMPA UDI Database
Medical Device Unique identification database shared with outside the world (NMPA, 31.03.2020).
CMDE announced that applications notified to submit additional technical reviews last year in February 2019 and would have needed to submit information until February 2020 (and to the end of the outbreak) will get another year to submit their information and encourages to use the eRPS system (due to temporary suspension of the on-site application acceptance).
器审中心关于落实《市场监管总局 国家药监局 国家知识产权局支持复工复产十条》有关事宜的通告（2020年第7号(CMDE, 26.02.2020).
Circular No. 9 of 2020 informs that NMPA plans to inspect medical device operations to ensure safety and effectiveness of the approved products and adds measures on quality check, responsibilities on the regulatory professionals involved and prohibits to accept gifts from overseas companies.
Circular No. 9 of 2020 (NMPA, 13.03.2020).
The Circular No 25 published in April 2020 updates
- - Definitions (e.g. serious injury, group adverse events or key monitoring)
- - Reporting timelines (time is extended slightly, e.g. serious injury 20 days, death 7 days)
- - Documentation (e.g. adverse event reporting form, requirement for periodic risk assessment report)
Circular No 25 (NMPA, 03.04.2020).
In 2020 NMPA plans to review various industry standards and publishes new ones. Besides many others the draft to adapt the latest IEC 60601-1 3rd Edition is important.
Announcement on 2020 medical device industry standards revision plan (NMPA, 17.03.2020).
IEC 60601-1 DRAFT GB 9706.1
The trial programm (limited to certain Class II, III and IV devices) scheduled to go on until end of March continues until end of 2020. Under this programm local responsible persons (LRPs) can demonstrate conformity with the essential principles on safety and performance of medical devices by providing MFDS approvals.
Continuance of trial to accept marketing approval obtained from the Ministry of Food and Drug Safety of Korea for listing application of medical devices under the Medical Device Administrative Control System (MDACS) (Medical Device Division, Department of Health, 10.03.2020).
The Directorate for Pharmaceuticals and Medical Devices in Indonesia changed beginning of March 2020, their domain from depkes.go.id to
Official Information (Ministry of Health Indonesia, 02.03.2020).
In addition regulation to withdraw medical devices containing mercury was published Withdrawal and removal of medical devices that contain mercury (Medical Device Division, 27.01.2020).
And after analysis good submission practices were published to inform on Class A and B filing Analysis and evaluation of industry capability in fulfilling Class A and B good submission practice (Medical Device Division, 03.02.2020).
PFDA intended to implement a new medical device authorization program in March 2020 but due to COVID-19 this is delayed and some services will not be available.
The update includes, besides others, a new possibility to bundle change notifications and a flowchart for changes on software for IVDs. The draft was published in December 2019.
GN-21: Guidance on Change Notification for Registered Medical Devices, rev. 4.7 (HSA, February 2020).
The new labelling requirements for products containing alcohol introduced in September 2019 should have been come into force in March 2020 and those products would have been subsequent to a stricter medical device regulation from then onwards.
Due to a possible shortage of such products during COVID-10 the regulation is postponed indefinitely and will implement it later again.
The new regulation defines as well information on the labelling such as
- Name and concentration of all components
- Number of the registration or notification
- Terms (if applicable): “for disinfection”, “single use only” or “for external use only”, “flammable substance” etc. (in red letters and in Thai language).
The name (and logo) change is done to better reflect the working party with members not only from Asia but as well from Africa, Middle East and South America.
New website www.ghwp.info will be endorsed at the next annual AHWP meeting in Singapore (postponed from March to June 2020).
Press release (AHWP, 30.03.2020).
In March IMDRF published various important new final guidances.
The cybersecurity guidance draft was published in December 2019 and the recent final guidance is the first one published by IMDRF on this subject.
Final Guidance: Principles and Practices for Medical Device Cybersecurity (IMDRF, 18.03.2020).
In the final Adverse Event terminology guidance (4th Edition) published, mostly terminologies are updated, revised or added (e.g. a new Annex G about medical device parts and components terminology was added).
In the EU the IMDRF terminology for adverse event monitoring is mandatory since January 2020.
Final Guidance: Terminologies for Categorized Adverse Event Reporting, Edition 4 (IMDRF, 18.03.2020).
This guidance (revised GHTF document) describes regulatory pathways for personalized medical devices (as defined in IMDRF document N49 Definitions for Personalized Medical Devices).
Final Guidance: Personalized Medical Devices – Regulatory Pathways (IMDRF, 18.03.2020).
- Schweiz: DSG-Revision: Erste Eckpunkte des neuen Datenschutzgesetzes stehen fest (Lexology, 13.02.2020).
- Regulatory operations, ethics and the global landscape (RAPS, 20.04.2020).
- Medtronic names its first chief inclusion and diversity officer (MassDevice, 24.02.2020).
- Australia: Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices (21.02.2020).
- Managing healthcare cybersecurity in 2020 pt.1 (BSI Compliance Navigator, 27.02.2020).
- European Parliament Approves Resolution on Artificial Intelligence (Lexology, 14.02.2020)