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UDI : FDA versus EU with CND taking center stage than GMDN

September 24, 2020 EU MDR

With increasing concerns for patient safety and efficient supply chain management, a single, globally harmonized identification system for medical devices is needed.

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Medical Devices - Regulatory Updates - September Vol. 2

September 17, 2020 Regulatory Updates

The UK has left the EU, and the transition period after Brexit comes to an end this year. Stakeholders need to get ready for new rules from 1 January 2021.

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Medical Devices - Regulatory Updates - September Vol. 1

September 03, 2020 Regulatory Updates

As of 1 September 2020, all medical devices used by care providers must have a CE marking. Since mid-March, due to shortages caused by the corona pandemic.

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Medical Devices - Regulatory Updates - August Volume 2

August 19, 2020 Regulatory Updates

In line with a reduction in restrictions, the inspectorate plans to resume an on-site UK risk-based GxP inspection programme starting in September.

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Devices and Diagnostics: 439 Clinical Studies for COVID-19

August 10, 2020 Covid-19

Based on number of clinical studies conducted on devices in each country, below shows TOP 10 countries:

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Medical Devices - Regulatory Updates - August Volume 1

August 04, 2020 Regulatory Updates

The European Commission has published an overview of the information that will be publicly available under EP and Council Regulation (EU) 2017/745 on medical devices.

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How companies Acquiring Healthcare solutions from SaMD resources

July 27, 2020 SaMD

With the new generation of medical devices, the software content in the devices is ever increasing.Software as a Medical Device (SaMD) brings new opportunities.

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For Med Device Companies, Why Resilience is more important now?

July 20, 2020 LCM

In the midst of the Covid-19 crisis, we have become painfully aware of the fragility of supply chains, health care, and other critical systems. Many leaders have announced.

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Medical Devices - Regulatory Updates - July Volume 2

July 16, 2020 Regulatory Updates

On the 9th of July 2020 the European Commission has adopted a Communication to help national authorities, businesses and citizens prepare for the inevitable changes.

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Medical Devices - Regulatory Updates - July Volume 1

July 02, 2020 Regulatory Updates

Due to the corona crisis the majority of the clinical trials conducted were put on hold. Since the Dutch Government currently gradually reduces the restrictive measures.

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Medical Devices - Regulatory Updates - June Volume 2

June 17, 2020 Regulatory Updates

The European Commission’s Medical Device Coordination Group (MDCG) issued guidance explaining the process for transitioning CE certificates

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Medical Devices - Regulatory Updates - June Volume 1

June 3, 2020 Regulatory Updates

The AEMPS extends the deadline until May 25, 2021 for the adequacy of the labeling and the instructions for use of medical devices as a consequence of the changes made by Brexit

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IVD Clinical Performance Studies for FDA & EU

June 02, 2020 IVDR

At present, the regulatory discussion pretty much focuses on MDR Regulation (EU) 2017/745 on medical devices. However, it seems the impact of Regulation (EU) 2017/746 on in vitro medical devices (IVDR).

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ISO 14971:2019 – Updates & older Version Differences

May 27, 2020 EU MDR

The third edition of ISO 14971 was finally released in December 2019 and it replaces ISO 14971:2007. The risk management process itself remains largely unchanged.

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Proactive strategies for Devices to minimize disruption

May 15, 2020 LCM

It is know that Medical devices have long as well as highly regulated life cycles. Most manufacturers handle their devices in market properly with measures like routine and reactive quality, complaint handling and safety.

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EU MDR Implementation Extension - Helps in Compliance Planning

May 07, 2020 EU MDR

We all aware that the implementation date of Medical Device Regulations (EU) 2017/745 (EU MDR) been extended by one year (26 May 2021) and the amendment was published...

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IVDR requirements for SOFTWARE

April 24, 2020 IVDR

Software fulfilling the definition of an in vitro diagnostic medical device falls under the In vitro diagnostic medical device regulation (EU) 2017/746 (IVDR). In the past, several of these are self-certified...

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FDA/EU/MHRA/TGA suggestions for ongoing clinical studies

April 08, 2020 EU MDR

There are several suggestions, recommendations from different health authorities for manufacturers to handle clinical trial aspects during this very challenging time of COVID.

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Real-World Approach in Collecting Clinical Data for MDR & IVDR

April 06, 2020 EU MDR

The deadline for MDR is drawing near and for IVDR too there is not much time. In such a situation, manufacturers are busy in the process of collecting all sorts of data.

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SSCP for Devices: Challenges and Approach

November 25, 2019 EU MDR

As per EU MDR, for class III and implantable devices (other than custom-made or investigational devices), a manufacturer needs to provide a summary of safety and clinical performance (SSCP).

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6 Best Practices to Navigate and Sustain Regulatory Labeling Compliance

November 18, 2019 Labeling

It has always been a difficult task to be compliant with the changing regulatory norms. When it comes to labeling, the criticality doubles as it becomes necessary to not only be compliant but to even...

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RAPS - 2019 Regulatory Convergence Round-up by MakroCare

October 03, 2019 EU MDR

Recently concluded RAPS- 2019 regulatory convergence at Philadelphia, PA was attended by a good number of representatives from pharma, biotech and device industries, from vendors offering...

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Deadline Extended for DMF Type III eCTD Submissions by FDA

August 29, 2019 eCTD

This being the third time in a row, the United States Food and Drug Administration (USFDA) has extended the compliance date for the submission of Type III Drug Master Files (DMFs) in electronic...

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Regulatory CMC Changes for Pharmaceutical Products

August 07, 2019 CMC

All the biopharmaceutical companies must follow respective nation’s laws or regulations in order to develop, manufacture and sale their pharmaceutical products. Before any biopharmaceutical product...

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Post Market Surveillance Planning and Challenges under EU MDR

July 11, 2019 EU MDR

PMS is a collection of processes and activities used to monitor the performance of a medical device. These activities are designed to generate information regarding use of the device to expediently...

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EUDAMED and EU Medical Device Nomenclature

March 20, 2019 EU MDR

The European Commission explain the details of how a future system for medical device nomenclature will help to support the EU’s new device and IVD regulations, as well as the Eudamed database...

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Use of Retrospective RWD for EU MDR Compliance

March 12, 2019 EU MDR

As EU MDR has already entered into force and will be applicable in May 2020, the device companies are getting geared up to be MDR compliant. EU MDR enforces stringent requirements related to...

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Med Device PMCF: How to get right Sample size

March 05, 2019 PMCF

Post Marketing Clinical Follow (PMCF) is a continuous process to assess and analyze clinical data pertaining to device to verify the clinical safety and performance of the device when used as...

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Labeling findings from FDA and other Agencies audits summary

March 01, 2019 Labeling

Regulatory environment has become increasingly complex and making drug labeling a highly regulated and closely monitored activity. As some of you are aware, Health authorities are specific...

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Effect of GDPR on Medical Devices in EU

February 25, 2019 EU MDR

Growth of technology brought forth internet enabled Medical Devices which can help with everything from the monitoring of patients to the collection and use of statistical data. This helps to improve...

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