Important Information About The Medical Devices

 Medical devices make up a huge and complex field in this world. There are a lot of devices which ranges from anything between a pacemaker and a thermometer. In these products they also come with some particular markings such as CE marking for medical devices and the FDA 510 K and also the NIOSH Certification etc. so firstly we would be talking about the medical devices CE marking which shows that the particular device which will meet the legal requirement for the major medical devices. If you want to place a CE mark on some certain medical device. The FDA, the US food and the drug regulatory body, has made a definition for all the devices. It always considers a particular medical device as an instrument, machine, apparatus, contrivance, implant, or the other similar related things

There are also some of the FDA 510k Consultants which has the lunar role for regulating all the medical devices in the industry. It is the one of the best software CE marking for all the medical devices, a role which has assumed all the considering to the serious health implications that are even for a smaller fault in a device which can cause something.

There is also some particular medical device classification of the medical devices such as:

1. Class 1 medical device.

2.Class 2 medical device.

3. Class III Medical Device.

What do you mean by FDA approval?

An FDA approval is for the medical devices which mean that the particular product is always ready and certified as it is ready for the marketing. Everytype of manufacturer has to get the FDA approval for their marketing advice. It has to always get this clearance through the premarket notification or what is being called as the FDA 510 K. The FDA will clear out the device which has been sent to the approval, or even reject it. If the device will meet the stringent criteria which is set by the FDA for the approval, then it is always considered as approved.

Is the 510(K) important for all the medical devices?

The answer is a big no. Not all the devices are in a need of going through the 510(K) process. Devices which are classified under, means that those devices which pose the least risk for the user don’t need a 510 (K). Only a few of the Class II and most of the Class III devices, which entails a higher risk for the user, are subjected to the510 (K) premarket approvals.

There is also some of the European authorized representative which helps the people by serving them as the legal entity which is designated by the non European Union manufacturers. The EU representative is the particular person which is designated, where it is applicable, to represent the companies which are not based in the Europe regarding the obligations that they have under the GDPR. Therefore it is the best thing that you can get.

The US FDA Consultants are also good at the Biocompatibility testing which can help you in a lot of ways by getting your device tested and approved.

Medical devices - Class III: General Controls and Premarket Approval

A Class III device needs to go through premarket approval (PMA) by the FDA before it can be marketed for use. Class III devices are usually invasive, life-sustaining, life-supporting, or is used “in preventing impairment of human health or if the device presents a potential unreasonable risk of illness or injury”.

In order to CE mark Class III devices the following requirements should be met to this end:

• Technical File for each family of devices should be prepared. This file should contain legal information, documentation, manufacturing process and performance of the product to show its effectiveness and safety. It includes the product Risk Analysis according to the EN 14971 harmonized European Standard, material safety data sheets, biocompatibility of materials, hygiene and sterility tests, manufacturing processes control procedures, operation manual/instructions, and any relevant documentation, as required by Exhibit I “Essential Requirements” of MDD, including clinical and medical support information. According to the type of device, some of these requirements may not apply.

• The Manufacturer must implement a Medical Quality Management System that will comply with the requirements of the MDD 93/42/EEC directive. The best, it to adopt a harmonized standard such as ISO 13485:2003 which s now the gold QMS standard in this Industry. In addition, we recommend, for commercial reasons, that this system should meet ISO 9001:2000, but ISO 9001:2000 alone does not comply with the requirements of the medical equipment directives. For more information, see CE QMS Requirements.

• Choose Conformity Assessment Route: refer the flow chart below.

• Declaration of Conformity.

• Ensure the device is a Class II medical device.

• Vigilance and Post Market Surveillance. (affix ce marking approval & market the products)

The conformity assessment routes for Class III Medical Devices

 

In the case of devices falling within Class III, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:

1. follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); or
2. follow the procedure relating to the EC type-examination set out in Annex III, coupled with:

(i) The procedure relating to the EC verification set out in Annex IV; or

(ii) The procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance).

Class III controls are similar to those for Class IIb devices but additionally require the manufacturer to submit the design dossier to the Notified Body for approval under Annex II and do not allow the Annex III/Annex VI option.

There are two routes:

1. Notified Body must carry out either an Annex II audit of the full quality assurance system (ISO 13485:2003), plus that the manufacturer must submit the design dossier to the Notified Body for approval under Annex II, or
2. Type-examination (Annex III) plus one of the two options given here:
   • Examination and testing of each product or homogenous batch of products (Annex IV); or
   • Audit of the production quality assurance system (Annex V  ISO 13485:2003 (excluding Design)

Once the manufacturer has received certification from the Notified Body he may CE mark his products and place them on the market.