Hi everyone, I am in the middle of compiling the technical file for our classIIb dental laser. The engineer and I were going through Annex 1 (essential requirements) of MDD 07/47/EC (the updated MDD 93/42/EEC) and we have some questions that I'm hoping you have some insight on.

Annex 1 - Section 6a
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.

- What are the guidelines to completing a clinical evaluation to conform to Annex X? As I understand it, we can either have a critical evaluation made of scienctific literature (but there would need to be an equivalent product out there that we could compare ours to), or a critical evaluation of the clinical data is required. How much data is required for the clinical evaluation? How did you set up your clinical investigations? What is the simplest way we can come up with a document showing we did one?

Annex 1 - Section 11 - Protection Against Radiation
11.2.1. Where devices are designed to emit hazardous levels of radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent in the emission, it must be possible for the user to control the emissions. Such devices shall be designed and manufactured to ensure reproducibility and tolerance of relevant variable parameters.

- Our dental laser has a screen which allows the user to control and wattage of the laser. Does this satisfy this requirement?

11.3.1. Devices shall be designed and manufactured in such a way that
exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible.

- How do we prove that the laser was manufactured to reduce unintended emission? What kind of documentation are they looking for?

Section 12.5
12.5. Devices must be designed and manufactured in such a way as to
minimize the risks of creating electromagnetic fields which could
impair the operation of other devices or equipment in the usual environment.

- Is this related to an FCC ID? Well I guess the FCC ID would probably only apply to USA, but would we be able to use that as evidence? What standard applies regarding electromagnetic fields?

Thanks everyone! I know this is a big post. I really appreciate any help you have to offer!

Annex I - Section 6a

You may started off with a scientific literature evaluation for establishing a Technical File but for Class IIb & III product, a clinical invstigation and evaluation have to be carried out. Some would do a literature review, put the product in market and conduct clinical investiogation as aprt of vigilent & post-market production requirement to make sure that the product is safe and effective.

Annex 1 - Section 11 - Protection Against Radiation

Check it out whether the radiation is under Class I or II. A simple laser point used in lecture hall is Class I but if use to as a weapon - it is adifferent classification. Prepare documentatiion to support the Class I laser requirement.

Section 12.5
Check if your device is EMC or EMI compliance. Set to UL for testing.

Regarding section 12.5:
Your question was :what standard applies regarding electromagnetic fields?

The answer to your question is:

EN 60601-1-2:2001
Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
and
Amendment A1:2006 to EN 60601-1-2:2001