by OMC Medical | May 24, 2021 | Regulation, Swiss AR
Medical devices are regulated by: the Swiss Agency for Therapeutic Product
Manufacturer Responsibility
- Ensuring medical devices are placed on the market is in accordance with the requirement of the medical device ordinance.
- Affixing the conformity mark and carrying out clinical evaluation according to Article 61 EU MDR.
- Keep technical documentation, declaration of conformity & any other certificates updated.
- At the request of a competent authority, the manufacturer should submit the technical documentation as per List Annexes II and III EU-MDR.
- Manufacturers must have at least one person in their organisation responsible for compliance with the regulations.
- A manufacturer based outside Switzerland must appoint an authorised representative.
- EUDAMED Registration, UDI
Mutual Recognition Agreement (MRA) between EU and Switzerland: Possible situations
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MRA updated before 26th May 2021
Depending on the terms of MRA, this situation will exempt the manufacturer from EU member states from the Swiss Authorized Representative(AR) requirement. European AR will be accepted as same as Swiss ARs and vice versa. Manufacturers outside the EU and Switzerland will still need to appoint EU AR or Swiss AR.
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MRA updated after 26th May 2021
This situation will require manufacturers from the EU and outside of the EU to appoint a Swiss AR. Between 26th May 2021 and the MRA update, Switzerland will be considered a third country for the EU during the transition period. MedDo will need to get updated suitable to the situation. Depending on the MRA status between the EU and Switzerland and the manufacturer’s location, the manufacturer has to decide if they should appoint a Swiss AR.
Switzerland Authorised Representative
- A Swiss authorized representative(Swiss AR) is a legal person appointed by a manufacturer established outside of Switzerland to place the products on the Swiss market.
- A written mandate/letter designating an authorised representative for a medical device manufacturer is mandatory.
- The manufacturer can appoint only a single Authorised representative in Switzerland.
- According to the Swiss ordinance on medical devices, the authorized representative is responsible for any product defects. AR is jointly and severally liable for product defects with the manufacturer.
Role of Authorised Representative
- Verify that the declaration of conformity and technical documentation has been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
- Keep available a copy of the technical documentation, the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, at the disposal of competent authorities for the period.
- Comply with the registration obligations and verify that the manufacturer has complied with the registration obligations.
- In response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the member state concerned.
- Forward to the manufacturer any request by a competent authority of the member state in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device.
- Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
- Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
- Terminate the mandate if the manufacturer acts contrary to its obligations under this regulation.
Registration in EUDAMED
- Eudamed is the European Databank on Medical Devices. It’s a secure, web-based portal developed by the European Commission to implement.
- The system is a collection of databases and electronic systems. It will function as a registration system, a collaborative system, a notification system, and a dissemination system (open to the public) and will be interoperable.
- Register at here: https://webgate.ec.europa.eu/eudamed/landing-page#/
- EUDAMED is structured around 6 interconnected electronic systems and a public website:
❑ Actors registration (Economic Operators)
❑ UDI/Devices registration
❑ Notified Bodies and Certificates
❑ Clinical Investigations and performance studies
❑ Vigilance and post-market surveillance
❑ Market Surveillance
Information in EUDAMED
Depending on the applicable directive, Eudamed2 contains data
a) On registration of manufacturers, authorised representatives, and devices
b) Declaration of conformity
c) Justification of the classification according to annex IX
d) A copy of the ISO certificate/Proof of QMS
e) Relating to certificates issued, modified, supplemented, suspended,
withdrawn, or refused
f) Obtained in accordance with the Medical DeviceVigilance System
g) Information on clinical investigations
Product Information
- The product information includes the labelling and the instructions for use.
- Must be written in the three official languages German, French, and Italian.
- Users are provided with additional information on request to be submitted in one of the official languages.
- The notice for products exclusively for demonstration and exhibition purposes should be present.
- Misleading or contradicting information about the intended use, safety and performance of a product is prohibited.
The latest update for Manufacturers in the EU & Swiss
EU Manufacturer exporting to Swiss: Need to appoint Swiss AR, update the labelling for MDR products & follow third country requirements
Timeline to appoint Swiss AR:
Swiss Manufacturer Exporting to EU:
- For MDR regulated devices & class I devices: Follow third country requirements from 26th May 2021.
- For MDD certified devices: No third country requirements, they will be regulated under MRA, free access to EU market as before until May 2024.
These requirements are subject to change depending on the MRA between the EU and Switzerland.
How we assist you with this process?
- Act as your Swiss Authorised Representative
- MedDO compliance
- EUDAMED registration
- Product information translations in German, French, Italian language
- EU MDR, IVDR gap analysis
by OMC Medical | Apr 30, 2021 | Newsletter
April Newsletter 2021: EU REGULATIONS
Factsheet for Class I – Medical Devices | 28 April Newsletter 2021
European commission published a Factsheet for Class I- Medical Devices based on MDCG 2019-5 rev. 1. for class I medical device manufacturers.
It summarizes the necessary steps to ensure the compliance of class I medical with applicable requirements of the EU-MDR 2017/745. The class I medical devices includes devices which are already placed in the market under MDD requirements and new devices expected to place on the market.
The FAQ give in factsheet helps to understand the requirements for Instruction for use and labels for class I device.
Guidance on basic UDI-DI and changes to UDI-DI MDCG 2018-1 Rev.4 | 27 April Newsletter 2021
Medical Device Coordination Group issued a Guidance on BASIC UDI-DI and changes to UDI-DI. This guidance explains the Basic UDI-DI & explain requirements of new UDI-DI for the device.
The Basic UDIDI is the primary key. It is not visible on any trade item. Basic UDI-DI is used for connecting devices with same intended purpose, risk class and essential design and manufacturing characteristics.
The new UDI-DI should be assigned to the device whenever there is a change that will lead to mislead the traceability of the device. These include changes in the following:
• Name or trade name
• Device version or model
• Labelled as single use
• Packaged sterile
• Need for sterilization before use
• Quantity of devices provided in a package
• Critical warnings or contra-indications (e.g. Containing latex or dehp)
• CMR /endocrine disruptors.
Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation MDCG
2021-6 | 22 April Newsletter 2021
Medical Device Coordination Group published Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation. This document is intended for clinical investigation sponsors.
The Q&A lays out the regulatory pathway for clinical investigations, also delivers guidance on difference between requirements
as per EU-MDR compared to Directive 93/42/EEC and 90/385/EEC, pilot clinical investigation, responsibilities of sponsor, safety reporting requirements, modifications to clinical investigations, timeline for clinical investigations, clinical investigation reports, arrangement for the transitional period.
Guidance on standardization for medical devices MDCG 2021-5 | 16 April 2021
Guidance on standardization for medical devices by MDCG explains general framework, development, and standardization of different harmonized European standards in support of the new legislative framework if the EU for medical device.
The new EU legislative framework on medical devices consists of three current Directives and two new Regulations. The guidance also provides adequate reference list for legal and guidance framework of EU.
Commission implementing decision (EU) 2021/611 | 14 April 2021
Following standards have been included in list of harmonized standards on biological evaluation of medical devices, packaging for terminally sterilized medical devices, sterilization of health care products and clinical investigation of medical devices for human subjects:
EN ISO 10993-16:2017
EN ISO 10993-18:2020
EN ISO 11607-1:2020
EN ISO 11737-2:2020
EN ISO 14155:2020
EN ISO 11607-2:2020
Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 MDCG 2021-4 | 09 April 2021
This document by Medical device coordination group includes indications for IVDR provisions for class D device related to notified body and EU reference laboratory (EURL) during transition period of EU legislation till 26 May 2022.
According to EU IVDR, in vitro medical device manufacturer needs to submit an application to notified body. As a part of conformity assessment for class D devices, whenever necessary specific elements might be reviewed by experts panel or tested in EURL.
This guidance issue helps class D IVD manufacturer.
Updated Implementation Rolling Plan – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 09 April 2021
The implementation rolling plan list down essential implementing acts and other relevant initiatives that the European commission has approved or will do so in the future.
UK MHRA
Medicines and Medical Devices Act 2021
An Act has been passed by UK government for patient safety related to human medicines and medical devices, veterinary medicines. This bill is to ensure the human safety by providing the regulations, enforcements for manufacture, marketing, and sales.
MHRA fees | 1 April 2021
The UK Government has published a new guidance to understand the changes to MHRA fees for 2021 – This guidance includes current MHRA fees for different categories of license, fees definition. These fees have come in force from 1 January 2021.
US FDA
FDA Emergency Use Authorization (EUA) routes for medical devices: Updated overview
April 5 2021
Due to Covid-19 last year FDA issued Emergency Use Authorization route for the in vitro diagnostics for the detection and/or diagnosis of COVID-19 personal respiratory protective devices, and other medical devices, including alternative products used as medical devices. This list has been updated with new tests and devices.
ASCA-Accredited Testing Laboratories | 14 April 2021
The FDA announces medical device testing laboratories accredited under ASCA program.
Medical Device Classification Regulations to Conform to Medical Software Provisions in the 21st Century Cures | 19 April 2021
FDA removes some software functions from medical device classification regulations to reflect the changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (the Cures Act).
This rule updates eight classification regulations. They do not include software functions that are excluded from the device definition by section 520(o)(1) of the FD&C Act hence does not fall under FDA’s device statutory authority.
HEALTH CANADA
Notice: Technical requirements for anti-microbial claims for medical masks | 21 April 2021
Health Canada publishes the notice for safety and effectiveness requirements for class I medical masks and face coverings with antimicrobial claims.
Face covers protecting the face from droplets or air particle without the anti-microbial claims are not considered as medical device. All new class I medical device mask with claim should support evidence and reports of necessary test for example Bacterial Filtration Efficiency (BFE).
Notice lists down total of nine safety and effectiveness requirement.
JAPAN PMDA
Digitization of package inserts | 27 April 2020
Japan PMDA issues guidance on package insert digitization requirements. Due to Pharmaceutical Machinery Act from now all the package inserts will be replaced by GS1 barcode or two-dimensional code which will contain the information regarding medical device.
This code will be scanned by PI (Package insert)-navi, A Smartphone App on phone or tablet to read the information like Emergency safety information such as package inserts, revision instruction reflection history, examination report / re-examination report, etc.
INDIA CDSCO
Regulation of CT Scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with effect from April 1st 2021
CDSCO India has passed an order for all implantable devices, CT scan equipment, MRI equipment, Defibrillators, PET equipment Dialysis machine, X-ray machine and bone marrow cell separator.
According to the order importers and manufacturers are required to take import/manufacturing license from the central licensing authority or state licensing authority from 1st April 2021 onwards.
AUSTRALIA TGA
TGA presentation: The regulation of medical device software | 14 April 2021
Therapeutic goods administration (TGA) of Australia has published the presentation on the regulation of medical device software on their website.
The presentation gives information on when a software can be considered as a medical devices and regulatory changes for medical device software.
CHINA NPMA
NMPA publishes guidelines for Device Master File (DMF) submissions | April 2021
National Medical Products Administration (NMPA) has released the guidance for DMF record filing requirements. It includes the necessary registration data for DMF filing application process for filing or renewal of DMF.
CMDE has announced the electronic DMF submissions using eRPS system. This announcement has included the guidance for application to become Certificate authority and format and content of DMF.
NMPA China Allows Laboratory Developed Test (LDT) | 29 April 2021
The new “Regulation for Medical Device Administration and Supervision”, Order 739 effecting from 1st June 2021 is replacing the Order 680. Article 53 in the order 739 allows the development of laboratory developed test (LDT) in China.
It allows the china medical institution to develop its own IVD reagents based on the clinical needs of the institutions. The medical institutions should meet certain criteria to produce its own IVD reagents.
Class II Medical Device Guidelines March 2021 | 16 April 2020
NMPA’s Center of Medical Device Evaluation (CMDE) and local testing centers has published the Class II medical device guidelines for 22 medical devices. This guideline instructs the renewals and new registrations process for the 22 Class II medical devices. Guidelines for devices used in Clinical Chemistry,
Orthopedic, General Hospital, Anesthesiology, Radiography, Gastroenterology / Urology has been issued.
PAKISTAN DRAP
Deployment of Pakistan Integrated Regulatory Information Management System At DRAP| 26 April 2020
Drug regulatory authority of Pakistan (DRAP) commences the use of Pakistan Integrated Regulatory Information Management System (PIRIMS) for the optimization of regulatory submission process. This digital platform will be used for new online applications of new drug manufacturing licenses (DML). The direct submission for DML will not be accepted.
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