Medical Devices - Regulatory Updates December Volume 1
Converting Centrally Authorised Products (CAPs) to UK Marketing Authorizations (MAs) from 1 January 2021, 'grandfathering' and managing lifecycle changes
This guidance covers 'grandfathering' and managing the lifecycle changes of medicinal products.
This guidance will apply from 1 January 2021 in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) 2019. It is our intention to update these Regulations to reflect the change of implementation dates following the Transition Period.
From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which were taken or carried out at EU-level except for decisions on Marketing Authorisation (MA) applications made through the European procedures to market products in Northern Ireland.
ANSM: EUDAMED database for medical devices: launch of the module for registering operators
The European Commission has announced the launch on December 1, 2020 of the first module of the EUDAMED medical device database. This module, called ACTORS, intended for economic operators and European health authorities will make it possible to prepare the entry into force of the new European regulation for medical devices, the date of which initially planned for 2020 has been postponed to May 26, 2021, due to COVID-19.
Information for economic operators
The registration of the operators concerned in the ACTORS module can be carried out from December 2020 on a voluntary basis with a view to the issuance of the SRN by the Agency.
- All manufacturers, assembly representatives (art. 22) and importers of medical devices, including those who have already registered with the ANSM, are invited to register in the ACTORS module, from this date in order to prepare the requirements of regulation 2017/745.
- These records allow these operators to meet their activity declaration obligations under Articles L.5211-3-1 and R. 5211-65 of the Public Health Code and exempt them, for these activities, from a national level registration.
- However, for activities for which operators do not have to register in EUDAMED (for example distributors, manufacturers of tailor-made MDs, etc.), the dedicated activity declaration of these operators to the ANSM continues in accordance with the provisions of Articles L. 5211-3-1, R. 5211-52, R. 5211-65 of the Public Health Code, pending new national provisions and this in addition to EUDAMED declarations for other activities if applicable.
MHRA: On-site access to Electronic Health Records by Sponsor representatives in clinical trials
The following guidance has been jointly developed by the Health Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
This guidance is for Sponsors, Contract Research Organisations (CROs) and investigator sites when considering management of personal data processed in relation to research. It should be read in conjunction with the HRA/MHRA joint advice on Data Protection Impact Assessments (DPIAs). In this context ‘processing’ also means access to EHRs.
The data collected and analyzed during clinical trials are verified and overseen by clinical trial Sponsors via representatives such as Clinical Research Associates (CRAs) or monitors. They will review the medical records to ensure that they match the data collected by the Sponsor, via Source Data Verification (SDV). The trial participants consent to this access of their medical records in writing, as part of the consent to take part in the clinical trial.
Clinical Trial Exemption (CTX) scheme renamed as Clinical Trial Approval (CTA) scheme
The Therapeutic Goods Administration (TGA) has changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical Trial Approval (CTA) scheme.
The name change from CTX to CTA more accurately reflects the nature of the scheme under the Therapeutic Goods Act 1989, which involves sponsors applying for the TGA's approval to supply unapproved therapeutic goods in Australia via a clinical trial despite the therapeutic goods not being entered in the Australian Register of Therapeutic Goods (ARTG). The scheme's previous name of CTX underscored the exemption given by the TGA to a sponsor from entering their therapeutic good in the ARTG before conducting a clinical trial.
The accompanying Clinical Trial Notification (CTN) scheme remains unchanged whereby any therapeutic goods used in clinical trials do not require evaluation and entry in the ARTG, although the TGA still needs to be notified of the sponsor's intent to conduct a clinical trial involving the unapproved good.
The TGA has updated our online information and application forms to reflect this name change from CTX to CTA. For consistency, they ask that relevant agencies and stakeholders also update their own documentation. The names of the clinical trials schemes are not explicitly mentioned in therapeutic goods legislation, so the proposed change will only impact our online information, application forms, and the Australian clinical trial handbook.
Updates to electronic application for a Conformity Assessment Certificate
The electronic application form for a Conformity Assessment Certificate that is accessible via the TGA Business Services (TBS) portal has been updated.
Under Application Type:
- Initial application from 'New conformity assessment certificate(s)' option
- Substantial change notification and application from 'Change to an existing certificate(s)' option
- Recertification of an expiring certificate when applying for recertification of a Conformity Assessment Certificate. This option was not available in the previous electronic form.
Under Device Details:
- Removal of the reference to NZ manufacturers in the context of CE certification, in accordance with the EU Medical Devices Directives.
Under the European Community - Australia Mutual Recognition Agreement (EC-MRA), the TGA can only to issue a CE certificate under MRA to Australian manufacturers.
Pilot Implementation of Food and Drug Administration (FDA) eService’s Portal System for License to Operate (LTO) Application of Medical Device Establishments
The Food and Drug Administration (FDA) is currently developing the FDA eService’s Portal System – an online platform for a streamlined License to Operate (LTO) application of FDA-regulated establishments.
In this regard, FDA is issuing this Advisory to inform all stakeholders that the application for eLTO for Medical Device Establishments within National Capital Region (NCR) is now on its pilot implementation. The eService’s Portal is accessible through this link eservices.fda.gov.ph/with the scope of the application is limited for the time being:
|FDA eService’s Portal for LTO Application for Medical Device Establishments|
|Location of Establishment||National Capital Region (Metro Manila)|
|LTO Establishment Application||Distributor (Wholesaler, Importer, Exporter), and Trader of Medical Devices, in-vitro diagnostic device, reagents, equipment or devices used for treating sharps, pathological and infectious waste and water purification system|
|Type of LTO Application||Initial, Renewal, and Variation|
|Fees to be Paid||Based on current issuance on Fees and Charges (Reference: DOH Administrative Order No. 50 s. 2001)|
|Validity of Initial LTO||Two (2) years|
|Start of Pilot Implementation||23 November 2020|
|End of Pilot Implementation||07 December 2020|
For this Pilot Run, applications for Renewal and Variation in the LTO using the eService’s Portal are only functional if the approved initial LTO is applied using the eService’s Portal.
For those with existing LTO application via ePortal, you may opt to apply to the eService’s Portal for a new fee. Previous payment will be forfeited as the application has already been processed.
Please follow Annex A of this Advisory for the Guideline and Checklist of Requirements, and Annex B for the Step-by-Step Guide in applying via eService’s Portal and the procedure for checking of application status.
Notice on matters related to on-site consultation on technical issues before the acceptance of medical device registration
The technical issues before medical device registration On-site consultation related matters are announced as follows:
1. On-site consultation time
From December 11, 2020 (Friday), every Friday (except statutory holidays) from 13:30 to 16:30 in the afternoon.
2. On-site consultation location
State Drug Administration Administrative Acceptance Service Hall (1st Floor, Gate 3, Dacheng Plaza, 28 Xuanwumen West Street, Xicheng District, Beijing)
3. Consultation department arrangement: still maintain the current rotation group, namely:
The first group: review one, review two, clinical and biostatistics one;
The second group: review three, review four, and review five;
The third group: Review six departments, clinical and biostatistics two, and integrated business department.
For the specific rotation arrangements of each consulting department, please pay attention to the notices on the consultation work arrangements for medical device registration before the acceptance of medical devices regularly published on our center website and We Chat public account.
4. Consultation Form
According to the situation of the prevention and control of the new crown pneumonia epidemic in Beijing, the consultation on technical issues before the registration of medical devices is carried out by appointment on-site consultation and non-appointment email consultation.