Steps for Getting CE Marking

  This subject is not unknown to anyone dealing with medical devices however just to reiterate the subject let us remember the objective. This is systematic planned process that contributes to continuous generation, collection, analysis, and evaluation of clinical data on a particular device. These words have lot of significance and each one has its own importance. Let us learn about how to accomplish that task. Before we go into this it is utmost   important to learn about the compliance requirement as defined in the various regulatory documents. This requirement is not new and was available in earlier document MDD also but with MDR coming into picture, there is lot of new requirements added to new devices also for the older devices which were already approved and had  CE mark. It is important to understand some guidelines MEDDEV 2.7/1 Rev 4 (2016) MDDG 2020–5 and 2020–6 and requirements from ISO 14155. Clinical Evaluation Report  is always a topic of audit by notif...

  As old manufacturer of medical device you were naturally MDD compliant and to remain in business you will have to become   MDR compliant   too. As Medical device business you also must have accounted the compliance cost  t o your product to assess the product cost and added your profitability to arrive at Product cost. The same exercise is now necessary as compliance cost will increase, in some cases substantially if your product class changes from say II to III. It is also difficult to explain to customer about increase in compliance cost may be some doctor may understand but overall, its difficult task. In view of this, whole exercise needs to be done with minimum expense and least possible time, so your approach must be thorough professional. Taking clue from  part I blog  let us ask some questions to ourselves and get answer ready and actions if needed. Study of guidance document MEDDEV 2.7.1 is must. 1. Clinical evaluation now applies to all classes ...

  MDD (Medical device directive) which was regulation for medical devices then in some EU countries is now getting replaced with new regulation called MDR (Medical Device Regulation) MDR is designed to be an improved version and one of the important facts is that it influences and effective in   all 27 member EU states including UK . Legal base of regulation will shift to EU and not like MDD where individual country was involved. One of the important steps i s  that even current companies with their products already in the market are also going to be influenced by new regulation and they must ensure their existing product comply to  MDR . This will help overall improvement in the field of medical device. Making some empirical comparison;  MDR is four times bigger document than MDD . The word safety appears 290 times as compared to 40 times in MDD. This itself explains the impact. Nothing is removed from MDD but lots of additions have been made in MDR. All additi...

  Without going into definition of compliance as it is clear precise word but has lot of implications on your product and business. Compliance is not a choice, but it is must. It is not debatable. Though guidelines are available it becomes difficult to interpret sometime leading to wrong path. Taking compliance lightly may lead to product safety issues thus heavy price to business. In Medical device field like any othe r  pharmaceutical, cosmetic product field, regulators have laid down certain rules and conditions for product safety and for the benefit of consumers who uses these products. Once you are compliant to say, USFDA requirement, it automatically means that products are safe to use, thus it gives sort of certification to consumers. Having said this, why it is necessary to have  USFDA consultant ? Regulatory requirements are everchanging phenomenon and it is difficult to keep chasing the same and understanding the compliance need for each requirement. That is whe...